A randomized, double-blind, active-controlled, parallel-group, multicenter study to determine the efficacy and safety of albiglutide as compared with sitagliptin in subjects with type 2 diabetes mellitus with renal impairment

INTERVENTION: Arm 1 (Experimental): albiglutide Intervention: Drug: albiglutida 30 mg weekly subcutaneous injection + sitagliptin matching placebo Arm (Active Comparator): sitagliptin albiglutide matching placebo + sitagliptin Intervention: Drug: albiglutide matching placebo + sitagliptin CONDITION: PRIMARY OUTCOME: Evaluation of the efficacy of albiglutide as compared with sitagliptin on the HbA1c change from Baseline; NAME OF THE RESULT: Glycosylated hemoglobin (HbA1c); USED MEASURING METHOD :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.; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time Frame: Week 26 SECONDARY OUTCOME: 1. HbA1c change from Baseline over time ; 2. Fasting plasma glucose (FPG) change from Baseline over time ; 3. Time to hyperglycemia rescue ; 4. Change from Baseline in body weight ; 5. The effect of plasma concentrations of albiglutide on glycemic control (population PK/PD) ; NAME OF THE RESULT: 1. HbA1c ; 2. Fasting plasma glucose ; 3. hyperglycemia ; 4. body weight ; 5. PK/PD parameters ; USED MEASURING METHOD :1. 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 ; 2. 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. ; 3. 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. ; 4. 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. ; 5. Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. ; ; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE SECONDARY RESULT: 1. Time Frame: up to 26 weeks ; 2. Time Frame: up to 26 weeks ; 3. Time Frame: 26 weeks ; 4. Time Frame: up to 26 weeks ; 5. Time Frame: 26 weeks ; 6. Time Frame: 26 weeks 2. •BMI >/=20 kg/m2 and /=0.8 ng/mL (>/=0.26 nmol/L) 4. •HbA1c between 7.0% and 10.0%, inclusive. Other protocol‐defined inclusion criteria apply. INCLUSION CRITERIA: 1. Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications