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To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days. |
|
| GW823093C 15 mg | Experimental | Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
|
| GW823093C 30 mg | Experimental | Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW823093 15mg | Drug | White opaque capsule containing 15mg of GW823093 as free base |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax) | PK parameters were calculated using data at the actual time of blood collection. Cmax was determined from plasma concentration-time data, using standard model independent methods. | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: Time at Which Cmax Was Observed (Tmax) | PK parameters were calculated using data at the actual time of blood collection. Tmax was determined from plasma concentration-time data, using standard model independent methods. | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: Half Life of Terminal Elimination Phase (t1/2) | PK parameters were calculated using data at the actual time of blood collection. T1/2 was determined from plasma concentration-time data, using standard model independent methods. | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: Area Under the Plasma Drug Concentration Versus Time Curve Extrapolated to Infinity (AUC[0-inf]), AUC From 0 to the Last Measurable Concentration (AUC[0-t]) | PK parameters were calculated using data at the actual time of blood collection. AUC[0-inf] and AUC[0-t] was determined from plasma concentration-time data, using standard model independent methods. | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) | PK parameters were calculated using data at the actual time of blood collection. %AUCex was determined from plasma concentration-time data, using standard model independent methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is serious corresponding to those listed in above definition. |
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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 |
A total of 30 participants were randomized in the study. After screening, participants were washed off of diabetes medications for two weeks prior to the first dose of study medication.
This study was conducted across two centers in Japan from 22 March 2006 to 28 June 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days. |
| FG001 | GW823093C 15 mg | Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
| FG002 | GW823093C 30 mg | Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
| BG001 | GW823093C 15 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax) | PK parameters were calculated using data at the actual time of blood collection. Cmax was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population comprised of all participants who received an active dose of GW823093C and for whom PK data was collected. | Posted | Geometric Mean | 95% Confidence Interval | Nanograms per milliliter (ng/mL) | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
AEs and SAEs were collected up to post-study screen (Follow-up [7 days after the last dose of study medication]).
Safety Population was used for the analysis.
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| 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 received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| GW823093 placebo capsule | Drug | Matching placebo of GW823093 capsule or 15mg capsule |
|
| GW823093 30mg | Drug | White opaque capsule containing 15mg of GW823093 as free base |
|
| Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: Constant Rate of Elimination (lambda_z) | PK parameters were calculated using data at the actual time of blood collection. Lambda_z was determined from plasma concentration-time data, using standard model independent methods. | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: Total Clearance (CL/F) | PK parameters were calculated using data at the actual time of blood collection. CL/F was determined from plasma concentration-time data, using standard model independent methods. | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: Apparent Volume of Distribution (Vz/F) | PK parameters were calculated using data at the actual time of blood collection. Vz/F was determined from plasma concentration-time data, using standard model independent methods. | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Standard PK Parameter: R[Cmax], Extent of Accumulation (Ro), Steady State Accumulation Ratio (Rs) | PK parameters were calculated using data at the actual time of blood collection. R[Cmax], Ro and Rs were determined from plasma concentration-time data, using standard model independent methods. R[Cmax] = Cmax (Day 7)/Cmax (Day 1), Ro = AUC(0-tau) (Day 7)/ AUC(0-tau) (Day 1) and Rs = AUC(0-tau) (Day 7)/ AUC(0-inf) (Day 1). | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
| Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7) | For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing ethylenediamine tetraacetic acid (EDTA2K) and centrifuged at approximately 4 degree Celsius, at approximately 2500 revolution per minute (rpm) for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. DPP-IV inhibition was estimated by using the percent change from pre-dose of DPP-IV activity. DPP-IV inhibition was done at pre-dose, 0.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr and 24 hr. | Day 7 |
| DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2K and centrifuged at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis has been presented in analysis. Unit of measure: Nano mole per minute per milliliter (nmol/min/mL). | Baseline (Day -1) and Day 7 |
| Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of active GLP-1 concentrations, approximately 3 mL of whole blood was collected into a vacuum tube containing DPP-IV inhibitor, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | Baseline (Day -1) and Day 7 |
| Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma insulin, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | Baseline (Day -1) and Day 7 |
| Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma glucagons concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing aprotinin, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | Baseline (Day -1) and Day 7 |
| C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma C-peptide concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | Baseline (Day -1) and Day 7 |
| Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma glucose concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing sodium fluoride, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | Baseline (Day -1) and Day 7 |
| Up to post-study screen (Follow-up [7 days after the last dose of study medication]) |
Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
| BG002 | GW823093C 30 mg | Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| GW823093C 30 mg |
Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. |
|
|
| Primary | Standard PK Parameter: Time at Which Cmax Was Observed (Tmax) | PK parameters were calculated using data at the actual time of blood collection. Tmax was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population. | Posted | Median | Full Range | Hour | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Standard PK Parameter: Half Life of Terminal Elimination Phase (t1/2) | PK parameters were calculated using data at the actual time of blood collection. T1/2 was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population. | Posted | Geometric Mean | 95% Confidence Interval | Hour | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Standard PK Parameter: Area Under the Plasma Drug Concentration Versus Time Curve Extrapolated to Infinity (AUC[0-inf]), AUC From 0 to the Last Measurable Concentration (AUC[0-t]) | PK parameters were calculated using data at the actual time of blood collection. AUC[0-inf] and AUC[0-t] was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population. | Posted | Geometric Mean | 95% Confidence Interval | Hr.ng/mL | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Standard PK Parameter: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) | PK parameters were calculated using data at the actual time of blood collection. %AUCex was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population. | Posted | Geometric Mean | 95% Confidence Interval | Percentage of AUCex | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Standard PK Parameter: Constant Rate of Elimination (lambda_z) | PK parameters were calculated using data at the actual time of blood collection. Lambda_z was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population. | Posted | Geometric Mean | 95% Confidence Interval | 1/hr | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Standard PK Parameter: Total Clearance (CL/F) | PK parameters were calculated using data at the actual time of blood collection. CL/F was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population. | Posted | Geometric Mean | 95% Confidence Interval | Liter per hour (L/hr) | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Standard PK Parameter: Apparent Volume of Distribution (Vz/F) | PK parameters were calculated using data at the actual time of blood collection. Vz/F was determined from plasma concentration-time data, using standard model independent methods. | PK Parameter Population. | Posted | Geometric Mean | 95% Confidence Interval | L | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Standard PK Parameter: R[Cmax], Extent of Accumulation (Ro), Steady State Accumulation Ratio (Rs) | PK parameters were calculated using data at the actual time of blood collection. R[Cmax], Ro and Rs were determined from plasma concentration-time data, using standard model independent methods. R[Cmax] = Cmax (Day 7)/Cmax (Day 1), Ro = AUC(0-tau) (Day 7)/ AUC(0-tau) (Day 1) and Rs = AUC(0-tau) (Day 7)/ AUC(0-inf) (Day 1). | PK Parameter Population. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr) |
|
|
|
| Primary | Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7) | For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing ethylenediamine tetraacetic acid (EDTA2K) and centrifuged at approximately 4 degree Celsius, at approximately 2500 revolution per minute (rpm) for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. DPP-IV inhibition was estimated by using the percent change from pre-dose of DPP-IV activity. DPP-IV inhibition was done at pre-dose, 0.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr and 24 hr. | Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available. | Posted | Number | Percent inhibition | Day 7 |
|
|
|
| Primary | DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2K and centrifuged at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis has been presented in analysis. Unit of measure: Nano mole per minute per milliliter (nmol/min/mL). | Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available. | Posted | Mean | Standard Deviation | nmol/min/mL | Baseline (Day -1) and Day 7 |
|
|
|
|
| Primary | Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of active GLP-1 concentrations, approximately 3 mL of whole blood was collected into a vacuum tube containing DPP-IV inhibitor, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | PD Parameter Population. | Posted | Mean | Standard Deviation | Picomole (pM) | Baseline (Day -1) and Day 7 |
|
|
|
|
| Primary | Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma insulin, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | PD Parameter Population. | Posted | Mean | Standard Deviation | Micro units per milliliter (µU/mL) | Baseline (Day -1) and Day 7 |
|
|
|
|
| Primary | Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma glucagons concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing aprotinin, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | PD Parameter Population. | Posted | Mean | Standard Deviation | Picogram per milliliter (pg/mL) | Baseline (Day -1) and Day 7 |
|
|
|
|
| Primary | C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma C-peptide concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | PD Parameter Population. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day -1) and Day 7 |
|
|
|
|
| Primary | Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7 | For the analysis of plasma glucose concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing sodium fluoride, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section. | PD Parameter Population. | Posted | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) | Baseline (Day -1) and Day 7 |
|
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is serious corresponding to those listed in above definition. | Safety Population comprised of all participants who received study medication (active or placebo). | Posted | Count of Participants | Participants | Up to post-study screen (Follow-up [7 days after the last dose of study medication]) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | GW823093C 15 mg | Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | GW823093C 30 mg | Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. | 0 | 10 | 0 | 10 | 0 | 10 |
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.
| AUC(0-inf), Day 1 |
|
| AUC(0-inf), Day 7 |
|
| Rs |
|
| Title | Measurements |
|---|---|
|
| 1hr |
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| 1.5hr |
|
| 2hr |
|
| 3hr |
|
| 4hr |
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| 6 hr |
|
| 8 hr |
|
| 12 hr |
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| 24 hr |
|
|
| AUC(0-24 hr), Day -1 |
|
| AUC(0-24 hr), Day 7 |
|
AUC(0-12 hr), Day 7
| Double-delta analysis |
| Mean Difference (Final Values) |
| -2.16 |
| 2-Sided |
| 95 |
| -2.33 |
| -1.98 |
The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. |
| Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | -1.98 | 2-Sided | 95 | -2.15 | -1.82 | The point estimate is the least square mean difference between placebo and GW 823093C 15 mg. | Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | -2.12 | 2-Sided | 95 | -2.28 | -1.95 | The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. | Superiority or Other |
|
| AUC(0-24 hr), Day -1 |
|
| AUC(0-24 hr), Day 7 |
|
AUC(0-12 hr), Day 7
| Double-delta analysis |
| Mean Difference (Final Values) |
| 5.21 |
| 2-Sided |
| 95 |
| 3.70 |
| 6.73 |
The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. |
| Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | 3.22 | 2-Sided | 95 | 1.90 | 4.54 | The point estimate is the least square mean difference between placebo and GW 823093C 15 mg. | Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | 4.39 | 2-Sided | 95 | 3.10 | 5.68 | The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. | Superiority or Other |
|
| AUC(0-24 hr), Day -1 |
|
| AUC(0-24 hr), Day 7 |
|
AUC(0-12 hr), Day 7
| Double-delta analysis |
| Mean Difference (Final Values) |
| 1.21 |
| 2-Sided |
| 95 |
| -3.30 |
| 5.72 |
The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. |
| Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | -1.35 | 2-Sided | 95 | -5.20 | 2.50 | The point estimate is the least square mean difference between placebo and GW 823093C 15 mg. | Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | 1.48 | 2-Sided | 95 | -2.47 | 5.43 | The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. | Superiority or Other |
|
| AUC(0-24 hr), Day -1 |
|
| AUC(0-24 hr), Day 7 |
|
AUC(0-12 hr), Day 7
| Double-delta analysis |
| Mean Difference (Final Values) |
| -16.2 |
| 2-Sided |
| 95 |
| -28.4 |
| -3.9 |
The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. |
| Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | -10.9 | 2-Sided | 95 | -23.1 | 1.4 | The point estimate is the least square mean difference between placebo and GW 823093C 15 mg. | Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | -15.6 | 2-Sided | 95 | -27.9 | -3.3 | The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. | Superiority or Other |
|
| AUC(0-24 hr), Day -1 |
|
| AUC(0-24 hr), Day 7 |
|
AUC(0-12 hr), Day 7
| Double-delta analysis |
| Mean Difference (Final Values) |
| 0.43 |
| 2-Sided |
| 95 |
| -0.47 |
| 1.32 |
The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. |
| Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | 0.35 | 2-Sided | 95 | -0.37 | 1.07 | The point estimate is the least square mean difference between placebo and GW 823093C 15 mg. | Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | 0.48 | 2-Sided | 95 | -0.24 | 1.21 | The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. | Superiority or Other |
|
| AUC(0-24 hr), Day -1 |
|
| AUC(0-24 hr), Day 7 |
|
AUC(0-12 hr), Day 7
| Double-delta analysis |
| Mean Difference (Final Values) |
| -9.0 |
| 2-Sided |
| 95 |
| -29.8 |
| 11.7 |
The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. |
| Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | -15.9 | 2-Sided | 95 | -33.2 | 1.4 | The point estimate is the least square mean difference between placebo and GW 823093C 15 mg. | Superiority or Other |
| AUC(0-24 hr), Day 7 | Double-delta analysis | Mean Difference (Final Values) | -6.2 | 2-Sided | 95 | -23.4 | 11.1 | The point estimate is the least square mean difference between placebo and GW 823093C 30 mg. | Superiority or Other |
| Title | Measurements |
|---|---|
|