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This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albiglutide | Active Comparator | albiglutide weekly subcutaneous injection + sitagliptin matching placebo |
|
| sitagliptin | Active Comparator | albiglutide matching placebo + sitagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albiglutide | Biological | albiglutide weekly subcutaneous injection + sitagliptin matching placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline; Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. |
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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 | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39963952 | Derived | Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2. | |
| 25387217 | Derived | Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836. |
| 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 |
|---|---|---|---|
| 114130 | Study Protocol | 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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Eligible participants entered into 2 weeks of Pre-screening and Screening; 4 weeks of Run-in/stabilization; 52-week Treatment Period for evaluation of efficacy and safety and 8 weeks of post treatment Follow-up. A total of 771 participants were screened, 507 were randomized and 495 received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Albiglutide 30 mg | Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| sitagliptin | Drug | albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment) |
|
| Baseline; Weeks 4, 8, 12, 16, and 20 |
| Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. | Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region. | Baseline; Week 26 |
| Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. | Baseline; Weeks 4, 8, 12, 16, 20, and 26 |
| Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52 |
| Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF | The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Week 26 |
| Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF | The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Week 26 |
| Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC | The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Week 52 |
| Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC | The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Week 52 |
| Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 | Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. | Week 2 to Week 52 |
| Time to Hyperglycemic Rescue Through Week 52 | Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks. | Week 2 to Week 52 |
| Change From Baseline in Body Weight at Week 26: LOCF | Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region. | Baseline; Week 26 |
| Change From Baseline in Body Weight Through Week 26: LOCF | Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. | Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26 |
| Change From Baseline in Body Weight Through Week 52: OC | Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. | Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52 |
| Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 | Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide. | Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide) |
| Gulf Shores |
| Alabama |
| 36542 |
| United States |
| GSK Investigational Site | Huntsville | Alabama | 35801 | United States |
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| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
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| GSK Investigational Site | Mogi das Cruzes | 08780 - 090 | Brazil |
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| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55116 | Germany |
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| GSK Investigational Site | Port Elizabeth | Eastern Cape | 6014 | South Africa |
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| GSK Investigational Site | Durban | KwaZulu-Natal | 4092 | South Africa |
| GSK Investigational Site | Phoenix | KwaZulu-Natal | 4068 | South Africa |
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| GSK Investigational Site | Coventry | West Midlands | CV2 2DX | United Kingdom |
| GSK Investigational Site | Birmingham | B9 5SS | United Kingdom |
| GSK Investigational Site | Hertfordshire | United Kingdom |
| GSK Investigational Site | Hull | HU3 2RW | United Kingdom |
| GSK Investigational Site | Liverpool | L9 7AL | United Kingdom |
| GSK Investigational Site | Livingston | EH54 6PP | United Kingdom |
| GSK Investigational Site | London | SE1 9NH | United Kingdom |
| GSK Investigational Site | Plymouth | PL6 8BX | United Kingdom |
| GSK Investigational Site | Swansea | SA6 6NL | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114130 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114130 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114130 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114130 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114130 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114130 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Albiglutide 30 mg | Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
| BG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 Glycosylated Hemoglobin (HbA1c) at Week 26 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c in the blood | Baseline; Week 26 |
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| Secondary | Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Percentage of HbA1c in the blood | Baseline; Weeks 4, 8, 12, 16, and 20 |
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| Secondary | Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Percentage of HbA1c in the blood | Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Millimoles per liter (mmol/L) | Baseline; Week 26 |
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| Secondary | Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline; Weeks 4, 8, 12, 16, 20, and 26 |
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| Secondary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52 |
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| Secondary | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF | The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | ITT Population. Only those participants available at the indicated time point were assessed. | Posted | Number | Participants | Week 26 |
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| Secondary | Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF | The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | ITT Population. Only those participants available at the indicated time point were assessed. | Posted | Number | Participants | Week 26 |
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| Secondary | Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC | The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | ITT Population. Only those participants available at the indicated time point were assessed. | Posted | Number | Participants | Week 52 |
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| Secondary | Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC | The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | ITT Population. Only those participants available at the indicated time point were assessed. | Posted | Number | Participants | Week 52 |
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| Secondary | Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 | Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. | ITT Population | Posted | Number | Participants | Week 2 to Week 52 |
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| Secondary | Time to Hyperglycemic Rescue Through Week 52 | Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks. | ITT Population | Posted | Median | 95% Confidence Interval | Weeks | Week 2 to Week 52 |
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| Secondary | Change From Baseline in Body Weight at Week 26: LOCF | Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Kilograms | Baseline; Week 26 |
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| Secondary | Change From Baseline in Body Weight Through Week 26: LOCF | Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Kilograms | Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26 |
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| Secondary | Change From Baseline in Body Weight Through Week 52: OC | Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Kilograms | Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52 |
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| Secondary | Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 | Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide. | ITT population. Only participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide) |
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Serious adverse events (SAEs) and non-serious AEs were collected from the time of study participation consent through Week 60, or the final follow-up visit for participants who discontinued active participation in the study (up to Study Week 60).
On-therapy SAEs and non-serious AEs (events with a start date on or after the first day of study medication [SM] and within 56 days after the end of SM) were collected in members of the Safety Population, comprised of all randomly assigned study participants who received at least one dose of SM.
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 | Albiglutide 30 mg | Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. | 30 | 249 | 174 | 249 | ||
| EG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. | 33 | 246 | 162 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac disorder | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia necrotising | Infections and infestations | MedDRA | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
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| Pyelonephritis chronic | Infections and infestations | MedDRA | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
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| Benign pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Pleural mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Rectosigmoid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cerebrovascular disorder | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
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| Viith nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Pain | General disorders | MedDRA | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Spinal ligament ossification | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Chronic obstructive pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Prostatomegaly | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Arterial thrombosis limb | Vascular disorders | MedDRA | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral vascular disorder | Vascular disorders | MedDRA | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Sternal fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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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 |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C534611 | rGLP-1 protein |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided
| Male |
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| American Indian or Alaskan Native |
|
| Asian - Central/South Asian Heritage |
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| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| Native Hawaiian or Other Pacific Islander |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
|
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| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
|
|
| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
|
|
| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
|
|
| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
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| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
|
|
| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
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Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
|
|
Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
|
|
| OG001 | Sitagliptin 100 mg | Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant's severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion. |
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