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This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for 14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin 850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg, 20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID. Subjects will return for a follow-up visit 7-10 days after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2330672 10 mg | Experimental | Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 10 mg BID for 14 days. |
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| GSK2330672 20 mg | Experimental | Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 20 mg BID for 14 days. |
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| GSK2330672 30 mg | Experimental | Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 30 mg BID for 14 days. |
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| GSK2330672 90 mg | Experimental | Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by GSK2330672 90 mg BID for 14 days. |
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| GSK2330672-matched placebo | Placebo Comparator | Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by matching placebo (of GSK2330672) BID for 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2330672 | Drug | GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment. | Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours) |
| Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) >= 3× upper limit of normal (ULN) and total bilirubin >=2 × ULN (>35% direct) or ALT >=3 × ULN and international normalized ratio >1.5. | Up to 14 days (treatment period) |
| Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided. | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chula Vista | California | 91910 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 201351 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 187 participants were screened, of these, 112 were screen failures and 75 entered the run-in period. Five participants were withdrawn prior to taking a metformin dose in the 14 days of run-in period. A total of 64 participants were randomized to receive investigational product, as 6 participants were withdrawn prior to randomization.
The study was conducted from 27 August 2014 to 30 January 2015. After interim analysis of safety, tolerability, pharmacodynamic and/or pharmacokinetic (PK) data, GSK2330672 10 and 20 milligram (mg) doses were dropped and GSK2330672 60 mg was added.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive matching placebo solution of GSK2330672 orally twice daily (BID) for 14 days. Participants drank the contents of dosing bottle (45 milliliters [mL]) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sitagliptin 50 mg | Active Comparator | Subjects will receive metformin 850 mg BID for 13-15 days during the run in period followed by Sitagliptin 50 mg BID for 14 days. In this study, sitagliptin 50 mg BID will be provided as open-label (unblinded) study treatment. |
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| Placebo | Drug | Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed |
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| Sitagliptin | Drug | Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days |
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| Metformin | Drug | Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14 |
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| Up to Day 15 |
| Number of Participants With Abnormal Clinical Chemistry With PCI | Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: >=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: >=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: >=1.5× ULN). | Up to Day 15 |
| Number of Participants With Abnormal Urinalysis Data | Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, >30, WBC: none seen, 0-5, 1, 2, 4, <5, 6-10, 11-30, 19, >30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality. | Baseline (pre-dose Day -1), Day 7 and 15 |
| Summary of Urinalysis Data-mean Specific Gravity | Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020. | Baseline (pre-dose Day -1), Day 7 and 15 |
| Summary of Urinalysis Data-mean pH | Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Baseline (pre-dose Day -1), Day 7 and 15 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented. | Up to Day 15 |
| Change From Baseline in Vital Signs Assessments-temperature | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. | Baseline (pre-dose Day -1) and, Day 7, 15 |
| Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. | Baseline (pre-dose Day -1) and Day 7, 15 |
| Change From Baseline in Vital Signs Assessments-heart Rate | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. | Baseline (pre-dose Day -1) and Day 7, 15 |
| Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions. | Up to Day 15 (administered after every in-house bowel movement) |
| Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions. | Up to Day 15 (administered after every in-house bowel movement) |
| Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in >=2 levels. | Day 7 and 14 |
| Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15. | Up to Day 15 |
| PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | The time at which Cmax observed was determined directly from the raw concentration-time data. | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 |
| PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | PK population. Only those participants available at the specified time points were analyzed. | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 |
| Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs. | Baseline (pre-dose Day -1) and Day 7, 14 |
| Ratio to Baseline in Fasting Apolipoprotein B | Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs. | Baseline (pre-dose Day -1) and Day 7, 14 |
| Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses | The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2). | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14 |
| Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses | The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin. | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14 |
| Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10) | The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14 |
| Miami |
| Florida |
| 33169 |
| United States |
| GSK Investigational Site | Baltimore | Maryland | 21225 | United States |
| GSK Investigational Site | San Antonio | Texas | 78209 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 201351 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201351 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201351 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201351 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201351 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201351 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| FG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| FG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| FG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| FG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| FG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
| FG007 | Run-in Only | Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| BG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| BG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| BG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| BG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| BG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| BG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
| BG007 | Run-in Only | Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| BG008 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment. | Safety population was used which was defined as all participants enrolled into the study who received at least one dose of study drug (including GSK2330672, GSK2330672-matched placebo, sitagliptin and metformin). Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Mg/deciliter | Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours) |
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| Primary | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) >= 3× upper limit of normal (ULN) and total bilirubin >=2 × ULN (>35% direct) or ALT >=3 × ULN and international normalized ratio >1.5. | Safety population. | Posted | Count of Participants | Participants | Up to 14 days (treatment period) |
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| Primary | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. | Safety population | Posted | Count of Participants | Participants | Up to Day 15 |
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| Primary | Number of Participants With Abnormal Clinical Chemistry With PCI | Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: >=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: >=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: >=1.5× ULN). | Safety population. | Posted | Count of Participants | Participants | Up to Day 15 |
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| Primary | Number of Participants With Abnormal Urinalysis Data | Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, >30, WBC: none seen, 0-5, 1, 2, 4, <5, 6-10, 11-30, 19, >30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality. | Safety population. | Posted | Count of Participants | Participants | Baseline (pre-dose Day -1), Day 7 and 15 |
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| Primary | Summary of Urinalysis Data-mean Specific Gravity | Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (pre-dose Day -1), Day 7 and 15 |
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| Primary | Summary of Urinalysis Data-mean pH | Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline (pre-dose Day -1), Day 7 and 15 |
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| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented. | Safety population | Posted | Count of Participants | Participants | Up to Day 15 |
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| Primary | Change From Baseline in Vital Signs Assessments-temperature | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Degree Celsius | Baseline (pre-dose Day -1) and, Day 7, 15 |
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| Primary | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (pre-dose Day -1) and Day 7, 15 |
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| Primary | Change From Baseline in Vital Signs Assessments-heart Rate | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (pre-dose Day -1) and Day 7, 15 |
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| Primary | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions. | Safety population | Posted | Mean | Standard Deviation | Count of bowel movements | Up to Day 15 (administered after every in-house bowel movement) |
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| Primary | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions. | Safety population. Only those participants available at the specified time points were analyzed. For each BSFS scale rating the "Number of Participants Analyzed" represents the number of participants reporting that rating not the number evaluated. | Posted | Number | Events | Up to Day 15 (administered after every in-house bowel movement) |
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| Primary | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in >=2 levels. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Day 7 and 14 |
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| Primary | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15. | Safety population | Posted | Count of Participants | Participants | Up to Day 15 |
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| Secondary | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided. | The PK population was used which was defined as participants from the safety population who had plasma metformin, sitagliptin, and/or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 |
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| Secondary | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | The time at which Cmax observed was determined directly from the raw concentration-time data. | PK population. Only those participants available at the specified time points were analyzed. | Posted | Median | Full Range | Hour | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 |
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| Secondary | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | PK population. Only those participants available at the specified time points were analyzed. | PK population. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour×ng/mL | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 |
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| Secondary | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs. | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Baseline (pre-dose Day -1) and Day 7, 14 |
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| Secondary | Ratio to Baseline in Fasting Apolipoprotein B | Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs. | Safety population | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Baseline (pre-dose Day -1) and Day 7, 14 |
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| Secondary | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses | The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2). | PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ng/mL | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14 |
|
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| Secondary | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses | The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin. | PK population. | Posted | Median | Full Range | Hour | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14 |
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| Secondary | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10) | The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. | PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour×ng/mL | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14 |
|
|
AEs and SAEs were collected from run-in period until the follow-up contact (7-10 days after discharge). SAEs and non-SAE were reported from treatment period only (up to 14 days).
Safety population used for assessment of safety results.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 0 | 13 | 0 | 13 | 9 | 13 |
| EG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 0 | 5 | 1 | 5 | 3 | 5 |
| EG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 0 | 9 | 0 | 9 | 8 | 9 |
| EG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. | 0 | 13 | 0 | 13 | 8 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA version | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA version | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA version | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA version | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA version | Systematic Assessment |
| |
| Scleral hyperaemia | Eye disorders | MedDRA version | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA version | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA version | Systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA version | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583160 | 3-((((3R,5R)-3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,4-benzothiazepin-8-yl)methyl)amino)pentanedioic acid |
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| Fasting, Day 14 |
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| WM AUC(0-24 hour), Day 7 |
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| WM AUC(0-24 hour), Day 14 |
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| An estimation approach was used. | Mean Difference (Net) | 13.22 | 2-Sided | 95 | -9.84 | 36.27 | Comparison for fasting, Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -21.77 | 2-Sided | 95 | -41.43 | -2.10 | Comparison for fasting, Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -23.10 | 2-Sided | 95 | -42.63 | -3.57 | Comparison for fasting, Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -11.79 | 2-Sided | 95 | -30.85 | 7.28 | Comparison for fasting, Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -10.04 | 2-Sided | 95 | -27.66 | 7.57 | Comparison for fasting, Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -15.14 | 2-Sided | 95 | -37.72 | 7.43 | Comparison for WM AUC(0-24 hour), Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -2.10 | 2-Sided | 95 | -23.66 | 19.45 | Comparison for WM AUC(0-24 hour), Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -20.66 | 2-Sided | 95 | -38.75 | -2.57 | Comparison for WM AUC(0-24 hour), Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -21.70 | 2-Sided | 95 | -39.70 | -3.71 | Comparison for WM AUC(0-24 hour), Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -10.62 | 2-Sided | 95 | -28.62 | 7.38 | Comparison for WM AUC(0-24 hour), Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -26.03 | 2-Sided | 95 | -41.94 | -10.12 | Comparison for WM AUC(0-24 hour), Day 7 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -12.10 | 2-Sided | 95 | -33.56 | 9.36 | Comparison for fasting, Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | 4.33 | 2-Sided | 95 | -15.91 | 24.57 | Comparison for fasting, Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -25.29 | 2-Sided | 95 | -42.56 | -8.02 | Comparison for fasting, Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -19.97 | 2-Sided | 95 | -37.12 | -2.82 | Comparison for fasting, Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -21.82 | 2-Sided | 95 | -38.56 | -5.08 | Comparison for fasting, Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -18.01 | 2-Sided | 95 | -33.48 | -2.55 | Comparison for fasting, Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -11.20 | 2-Sided | 95 | -33.21 | 10.81 | Comparison for WM AUC(0-24 hour), Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | 4.80 | 2-Sided | 95 | -16.22 | 25.81 | Comparison for WM AUC(0-24 hour), Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -15.23 | 2-Sided | 95 | -32.86 | 2.41 | Comparison for WM AUC(0-24 hour), Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -17.01 | 2-Sided | 95 | -34.56 | 0.53 | Comparison for WM AUC(0-24 hour), Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -23.94 | 2-Sided | 95 | -41.49 | -6.39 | Comparison for WM AUC(0-24 hour), Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| An estimation approach was used. | Mean Difference (Net) | -19.45 | 2-Sided | 95 | -34.96 | -3.93 | Comparison for WM AUC(0-24 hour), Day 14 | Superiority or Other | An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate. |
| OG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
| OG007 | Run-in Only | Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
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| OG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
| OG007 | Run-in Only | Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
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| OG001 | GSK2330672 10 mg BID | Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing.
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| GSK2330672 10 mg BID |
Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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| OG002 | GSK2330672 20 mg BID | Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG003 | GSK2330672 30 mg BID | Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG004 | GSK2330672 60 mg BID | Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG005 | GSK2330672 90 mg BID | Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. |
| OG006 | Sitagliptin 50 mg BID | Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. |
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