Trial Outcomes & Findings for A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment. (NCT NCT01098539)

Last Updated: 2017-02-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

507 participants

Primary outcome timeframe

Baseline; Week 26

Results posted on

2017-02-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	249	246
Overall Study COMPLETED	198	178
Overall Study NOT COMPLETED	51	68

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	26	26
Overall Study Protocol Violation	1	4
Overall Study Noncompliance	3	5
Overall Study Lost to Follow-up	4	4
Overall Study Withdrawal by Subject	12	26
Overall Study Physician Decision	5	3

Baseline Characteristics

A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albiglutide 30 mg n=249 Participants 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.	Sitagliptin 100 mg n=246 Participants 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.	Total n=495 Participants Total of all reporting groups
Age, Continuous	63.2 Years STANDARD_DEVIATION 8.37 • n=5 Participants	63.5 Years STANDARD_DEVIATION 9.02 • n=7 Participants	63.3 Years STANDARD_DEVIATION 8.69 • n=5 Participants
Gender Female	113 Participants n=5 Participants	116 Participants n=7 Participants	229 Participants n=5 Participants
Gender Male	136 Participants n=5 Participants	130 Participants n=7 Participants	266 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	36 Participants n=5 Participants	42 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	45 Participants n=5 Participants	33 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	112 Participants n=5 Participants	111 Participants n=7 Participants	223 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 26

Population: 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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=242 Participants 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.	Sitagliptin 100 mg n=236 Participants 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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26	-0.83 Percentage of HbA1c in the blood Standard Error 0.062	-0.52 Percentage of HbA1c in the blood Standard Error 0.063

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 8, 12, 16, and 20

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF Week 4, n=237, 234	-0.43 Percentage of HbA1c in the blood Standard Deviation 0.460	-0.37 Percentage of HbA1c in the blood Standard Deviation 0.512
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF Week 12, n=242, 236	-0.69 Percentage of HbA1c in the blood Standard Deviation 0.840	-0.56 Percentage of HbA1c in the blood Standard Deviation 0.989
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF Week 16, n=242, 236	-0.75 Percentage of HbA1c in the blood Standard Deviation 0.886	-0.56 Percentage of HbA1c in the blood Standard Deviation 1.103
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF Week 8, n=242, 236	-0.60 Percentage of HbA1c in the blood Standard Deviation 0.663	-0.52 Percentage of HbA1c in the blood Standard Deviation 0.785
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF Week 20, n=242, 236	-0.79 Percentage of HbA1c in the blood Standard Deviation 0.890	-0.54 Percentage of HbA1c in the blood Standard Deviation 1.083

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 4, n=233, 228	-0.43 Percentage of HbA1c in the blood Standard Deviation 0.463	-0.37 Percentage of HbA1c in the blood Standard Deviation 0.512
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 48, n=172, 139	-1.01 Percentage of HbA1c in the blood Standard Deviation 0.884	-0.89 Percentage of HbA1c in the blood Standard Deviation 0.977
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 52, n=157, 118	-1.04 Percentage of HbA1c in the blood Standard Deviation 0.796	-1.03 Percentage of HbA1c in the blood Standard Deviation 0.883
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 8, n=222, 213	-0.63 Percentage of HbA1c in the blood Standard Deviation 0.677	-0.56 Percentage of HbA1c in the blood Standard Deviation 0.794
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 12, n=224, 216	-0.71 Percentage of HbA1c in the blood Standard Deviation 0.832	-0.62 Percentage of HbA1c in the blood Standard Deviation 0.940
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 16, n=218, 209	-0.75 Percentage of HbA1c in the blood Standard Deviation 0.885	-0.63 Percentage of HbA1c in the blood Standard Deviation 1.085
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 20, n=207, 196	-0.86 Percentage of HbA1c in the blood Standard Deviation 0.852	-0.71 Percentage of HbA1c in the blood Standard Deviation 0.931
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 26, n=202, 178	-0.93 Percentage of HbA1c in the blood Standard Deviation 0.806	-0.80 Percentage of HbA1c in the blood Standard Deviation 0.887
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Week 36, n=192, 155	-1.01 Percentage of HbA1c in the blood Standard Deviation 0.808	-0.82 Percentage of HbA1c in the blood Standard Deviation 1.014

SECONDARY outcome

Timeframe: Baseline; Week 26

Population: ITT Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=244 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	-1.42 Millimoles per liter (mmol/L) Standard Error 0.183	-0.22 Millimoles per liter (mmol/L) Standard Error 0.184

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 8, 12, 16, 20, and 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 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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF Week 4, n=244, 240	-1.47 Millimoles per liter (mmol/L) Standard Deviation 3.054	-0.84 Millimoles per liter (mmol/L) Standard Deviation 2.670
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF Week 8, n=244, 240	-1.19 Millimoles per liter (mmol/L) Standard Deviation 3.115	-0.82 Millimoles per liter (mmol/L) Standard Deviation 3.169
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF Week 12, n=244, 240	-1.35 Millimoles per liter (mmol/L) Standard Deviation 2.930	-0.81 Millimoles per liter (mmol/L) Standard Deviation 3.214
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF Week 16, n=244, 240	-1.34 Millimoles per liter (mmol/L) Standard Deviation 3.070	-0.49 Millimoles per liter (mmol/L) Standard Deviation 3.440
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF Week 20, n=244, 240	-1.37 Millimoles per liter (mmol/L) Standard Deviation 3.198	-0.62 Millimoles per liter (mmol/L) Standard Deviation 3.257

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
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 Week 4, n=231, 226	-1.55 Millimoles per liter (mmol/L) Standard Deviation 2.859	-0.76 Millimoles per liter (mmol/L) Standard Deviation 2.569
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 Week 8, n=221, 210	-1.24 Millimoles per liter (mmol/L) Standard Deviation 2.896	-0.74 Millimoles per liter (mmol/L) Standard Deviation 2.877
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 Week 12, n=224, 216	-1.46 Millimoles per liter (mmol/L) Standard Deviation 2.623	-0.88 Millimoles per liter (mmol/L) Standard Deviation 2.723
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 Week 20, n=207, 191	-1.51 Millimoles per liter (mmol/L) Standard Deviation 2.859	-1.00 Millimoles per liter (mmol/L) Standard Deviation 2.474
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 Week 36, n=186, 149	-1.42 Millimoles per liter (mmol/L) Standard Deviation 2.788	-0.92 Millimoles per liter (mmol/L) Standard Deviation 2.628
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 Week 1, n=219, 217	-0.82 Millimoles per liter (mmol/L) Standard Deviation 2.572	-0.93 Millimoles per liter (mmol/L) Standard Deviation 2.207
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 Week 2, n=226, 223	-1.28 Millimoles per liter (mmol/L) Standard Deviation 2.569	-0.66 Millimoles per liter (mmol/L) Standard Deviation 2.319
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 Week 3, n=230, 219	-1.25 Millimoles per liter (mmol/L) Standard Deviation 3.168	-0.88 Millimoles per liter (mmol/L) Standard Deviation 2.136
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 Week 16, n=214, 204	-1.41 Millimoles per liter (mmol/L) Standard Deviation 2.796	-0.55 Millimoles per liter (mmol/L) Standard Deviation 3.023
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 Week 26, n=200, 177	-1.54 Millimoles per liter (mmol/L) Standard Deviation 2.507	-0.58 Millimoles per liter (mmol/L) Standard Deviation 2.673
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 Week 48, n=165, 140	-1.08 Millimoles per liter (mmol/L) Standard Deviation 2.720	-0.58 Millimoles per liter (mmol/L) Standard Deviation 2.725
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 Week 52, n=149, 114	-1.06 Millimoles per liter (mmol/L) Standard Deviation 2.850	-0.96 Millimoles per liter (mmol/L) Standard Deviation 2.281

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population. Only those participants available at the indicated time point were assessed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=242 Participants 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.	Sitagliptin 100 mg n=236 Participants 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.
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF HbA1c <6.5%	37 Participants	29 Participants
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF HbA1c <7.0%	103 Participants	72 Participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT Population. Only those participants available at the indicated time point were assessed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=242 Participants 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.	Sitagliptin 100 mg n=236 Participants 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.
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 HbA1c >=1.0%	102 Participants	77 Participants
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 HbA1c >=1.5%	49 Participants	38 Participants
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 HbA1c >=2.0%	26 Participants	17 Participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT Population. Only those participants available at the indicated time point were assessed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=157 Participants 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.	Sitagliptin 100 mg n=118 Participants 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.
Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC HbA1c <6.5%	44 Participants	27 Participants
Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC HbA1c <7.0%	98 Participants	61 Participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT Population. Only those participants available at the indicated time point were assessed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=157 Participants 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.	Sitagliptin 100 mg n=118 Participants 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.
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 HbA1c >=1.5%	43 Participants	30 Participants
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 HbA1c >=1.0%	79 Participants	65 Participants
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 HbA1c >=2.0%	20 Participants	15 Participants

SECONDARY outcome

Timeframe: Week 2 to Week 52

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 2	0 Participants	2 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 4	0 Participants	2 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 12	2 Participants	5 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 16	5 Participants	6 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 26	15 Participants	29 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 8	1 Participants	3 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 20	9 Participants	14 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 36	25 Participants	47 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 48	33 Participants	53 Participants
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Week 52	44 Participants	68 Participants

SECONDARY outcome

Timeframe: Week 2 to Week 52

Population: ITT Population

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Time to Hyperglycemic Rescue Through Week 52	NA Weeks There were too few events of hyperglycemia rescue (\<50% of participants with events) to calculate the median and confidence interval.	NA Weeks There were too few events of hyperglycemia rescue (\<50% of participants with events) to calculate the median and confidence interval.

SECONDARY outcome

Timeframe: Baseline; Week 26

Population: ITT Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=244 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Change From Baseline in Body Weight at Week 26: LOCF	-0.79 Kilograms Standard Error 0.192	-0.19 Kilograms Standard Error 0.194

SECONDARY outcome

Timeframe: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Change From Baseline in Body Weight Through Week 26: LOCF Week 3, n=244, 240	-0.25 Kilograms Standard Deviation 1.392	0.01 Kilograms Standard Deviation 1.530
Change From Baseline in Body Weight Through Week 26: LOCF Week 4, n=244, 240	-0.33 Kilograms Standard Deviation 1.456	0.09 Kilograms Standard Deviation 1.806
Change From Baseline in Body Weight Through Week 26: LOCF Week 12, n=244, 240	-0.47 Kilograms Standard Deviation 2.055	0.03 Kilograms Standard Deviation 2.254
Change From Baseline in Body Weight Through Week 26: LOCF Week 1, n=225, 225	-0.17 Kilograms Standard Deviation 1.215	0.12 Kilograms Standard Deviation 1.237
Change From Baseline in Body Weight Through Week 26: LOCF Week 2, n=241, 238	-0.21 Kilograms Standard Deviation 1.317	-0.02 Kilograms Standard Deviation 1.423
Change From Baseline in Body Weight Through Week 26: LOCF Week 8, n=244, 240	-0.58 Kilograms Standard Deviation 1.768	0.02 Kilograms Standard Deviation 1.952
Change From Baseline in Body Weight Through Week 26: LOCF Week 16, n=244, 240	-0.63 Kilograms Standard Deviation 2.197	-0.08 Kilograms Standard Deviation 2.564
Change From Baseline in Body Weight Through Week 26: LOCF Week 20, n=244, 240	-0.69 Kilograms Standard Deviation 2.556	-0.07 Kilograms Standard Deviation 2.878

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=246 Participants 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.	Sitagliptin 100 mg n=240 Participants 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.
Change From Baseline in Body Weight Through Week 52: OC Week 48, n=172, 140	-0.93 Kilograms Standard Deviation 3.829	0.07 Kilograms Standard Deviation 3.349
Change From Baseline in Body Weight Through Week 52: OC Week 1, n=225, 225	-0.17 Kilograms Standard Deviation 1.215	0.12 Kilograms Standard Deviation 1.237
Change From Baseline in Body Weight Through Week 52: OC Week 2, n=232, 227	-0.21 Kilograms Standard Deviation 1.339	-0.01 Kilograms Standard Deviation 1.438
Change From Baseline in Body Weight Through Week 52: OC Week 3, n=236, 224	-0.24 Kilograms Standard Deviation 1.404	0.03 Kilograms Standard Deviation 1.544
Change From Baseline in Body Weight Through Week 52: OC Week 4, n=235, 230	-0.31 Kilograms Standard Deviation 1.466	0.10 Kilograms Standard Deviation 1.827
Change From Baseline in Body Weight Through Week 52: OC Week 8, n=226, 214	-0.61 Kilograms Standard Deviation 1.800	0.05 Kilograms Standard Deviation 2.012
Change From Baseline in Body Weight Through Week 52: OC Week 12, n=228, 219	-0.45 Kilograms Standard Deviation 2.091	0.16 Kilograms Standard Deviation 2.193
Change From Baseline in Body Weight Through Week 52: OC Week 16, n=223, 210	-0.68 Kilograms Standard Deviation 2.226	0.07 Kilograms Standard Deviation 2.589
Change From Baseline in Body Weight Through Week 52: OC Week 20, n=211, 198	-0.76 Kilograms Standard Deviation 2.619	0.09 Kilograms Standard Deviation 2.976
Change From Baseline in Body Weight Through Week 52: OC Week 26, n=202, 178	-0.87 Kilograms Standard Deviation 2.856	-0.04 Kilograms Standard Deviation 3.465
Change From Baseline in Body Weight Through Week 52: OC Week 36, n=190, 155	-0.92 Kilograms Standard Deviation 3.551	0.01 Kilograms Standard Deviation 2.975
Change From Baseline in Body Weight Through Week 52: OC Week 52, n=157, 119	-0.82 Kilograms Standard Deviation 3.931	0.31 Kilograms Standard Deviation 3.685

SECONDARY outcome

Timeframe: 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)

Population: ITT population. Only participants with data available at the indicated time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg n=228 Participants 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.	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.
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 Week 8, Pre-dose, n=223	3005.80 nanograms per milliliter (ng/mL) Standard Deviation 1788.544	—
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 Week 8, Post-dose, n=220	3452.62 nanograms per milliliter (ng/mL) Standard Deviation 1912.329	—
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 Week 16, Pre-dose, n=215	2994.15 nanograms per milliliter (ng/mL) Standard Deviation 1759.161	—
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 Week 16, Post-dose, n=205	3583.06 nanograms per milliliter (ng/mL) Standard Deviation 2239.026	—

Adverse Events

Albiglutide 30 mg

Serious events: 30 serious events

Other events: 174 other events

Deaths: 0 deaths

Sitagliptin 100 mg

Serious events: 33 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER