Diabetes Mellitus, Type 2
Conditions
Keywords
GSK716155, liraglutide, albiglutide, open-label
Brief summary
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
Detailed description
This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.
Interventions
albiglutide weekly subcutaneous injection
liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications * BMI \>/=20kg/m2 and \</=45 kg/m2 * Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L) * HbA1c between 7.0% and 10.0%, inclusive * Female subjects of childbearing potential must be practicing adequate contraception.
Exclusion criteria
* History of cancer * History of treated diabetic gastroparesis * Current biliary disease or history of pancreatitis * History of significant GI surgery * Recent clinically significant cardiovascular and/or cerebrovascular disease * Hypertension * History of human immunodeficiency virus infection * History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C * History of alcohol or substance abuse * Female subject is pregnant, lactating, or \<6 weeks postpartum * Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast * History of type 1 diabetes mellitus * Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide) * Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies * History or family history of thyroid disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 | Baseline and Week 32 | 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 32 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32 | Baseline and Week 32 | 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 was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. 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 considered in the treatment week if they had received at least one dose in that treatment week. |
| Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 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 was calculated as the post-Baseline value minus the value at Baseline. 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 considered in the treatment week if they had received at least one dose in that treatment week. |
| Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Baseline, Weeks 4, 6, 12, 18 and 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 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 considered in the treatment week if they had received at least one dose in that treatment week. |
| Time to Hyperglycemia Rescue at Week 32 | Week 32 | Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) \>=280 milligram/decilitre (mg/dL) \>= Week 2 and \< Week 4, FPG \>=250 mg/dL \>= Week 4 and \<Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- \>= Week 12 and \<Week 26, or HbA1c ≥8.5% \>= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32. |
| Mean Change From Baseline in Body Weight at Week 32 | Baseline and Week 32 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. 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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. |
| Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32 | Week 32 | Number of participants who achieved HbA1c response levels of \<6.5% and \<7.0% at Week 32 were assessed. 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. |
Countries
Australia, Israel, Peru, Philippines, South Korea, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Eligible participants entered into 2 weeks of Prescreening and Screening; 4 weeks of Run-in/stabilization; a 32-week Treatment Period for evaluation of efficacy and safety and 8 weeks of post treatment Follow-up. A total of 1764 participants were screened, 841 were randomized and 812 received at least one dose of study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Albiglutide 50 mg Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6. | 404 |
| Liraglutide 1.8 mg Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg. | 408 |
| Total | 812 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 31 | 41 |
| Overall Study | Conflicting HbA1c Results at Screening | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 8 |
| Overall Study | Noncompliance | 4 | 5 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 12 |
Baseline characteristics
| Characteristic | Albiglutide 50 mg | Liraglutide 1.8 mg | Total |
|---|---|---|---|
| Age, Continuous | 55.4 Years STANDARD_DEVIATION 10.11 | 55.8 Years STANDARD_DEVIATION 9.95 | 55.6 Years STANDARD_DEVIATION 10.03 |
| Gender Female | 213 Participants | 190 Participants | 403 Participants |
| Gender Male | 191 Participants | 218 Participants | 409 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 47 Participants | 29 Participants | 76 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 30 Participants | 37 Participants | 67 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 3 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 26 Participants | 18 Participants | 44 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 17 Participants | 19 Participants | 36 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 276 Participants | 285 Participants | 561 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 266 / 404 | 289 / 408 |
| serious Total, serious adverse events | 20 / 404 | 23 / 408 |
Outcome results
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
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 32 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.
Time frame: Baseline and Week 32
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Albiglutide 50 mg | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 | -0.78 Percentage of HbA1c in the blood | Standard Error 0.047 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 | -0.99 Percentage of HbA1c in the blood | Standard Error 0.046 |
Mean Change From Baseline in Body Weight at Week 32
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. 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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.
Time frame: Baseline and Week 32
Population: ITT Population. Only those participants available at the indicated time point were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albiglutide 50 mg | Mean Change From Baseline in Body Weight at Week 32 | -0.62 Kilograms | Standard Deviation 3.118 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Body Weight at Week 32 | -2.21 Kilograms | Standard Deviation 4.147 |
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32
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 was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. 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 considered in the treatment week if they had received at least one dose in that treatment week.
Time frame: Baseline and Week 32
Population: ITT Population. Only those participants available at the indicated time point were assessed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32 | -1.22 Millimoles per liter (mmol/L) | Standard Error 0.115 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32 | -1.68 Millimoles per liter (mmol/L) | Standard Error 0.115 |
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 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 was calculated as the post-Baseline value minus the value at Baseline. 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 considered in the treatment week if they had received at least one dose in that treatment week.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 6, n= 400, 402 | -1.25 Millimoles per liter (mmol/L) | Standard Deviation 2.317 |
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 1, n=386, 381 | -0.98 Millimoles per liter (mmol/L) | Standard Deviation 1.939 |
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 12, n= 400, 402 | -1.73 Millimoles per liter (mmol/L) | Standard Deviation 2.526 |
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 2, n= 399, 398 | -1.33 Millimoles per liter (mmol/L) | Standard Deviation 2.194 |
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 18, n= 400, 402 | -1.44 Millimoles per liter (mmol/L) | Standard Deviation 2.362 |
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 3, n= 400, 402 | -1.61 Millimoles per liter (mmol/L) | Standard Deviation 2.067 |
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 26, n= 400, 402 | -1.14 Millimoles per liter (mmol/L) | Standard Deviation 2.694 |
| Albiglutide 50 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 4, n= 400, 402 | -1.52 Millimoles per liter (mmol/L) | Standard Deviation 2.148 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 26, n= 400, 402 | -1.64 Millimoles per liter (mmol/L) | Standard Deviation 2.717 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 2, n= 399, 398 | -2.25 Millimoles per liter (mmol/L) | Standard Deviation 2.296 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 3, n= 400, 402 | -2.43 Millimoles per liter (mmol/L) | Standard Deviation 2.47 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 4, n= 400, 402 | -2.45 Millimoles per liter (mmol/L) | Standard Deviation 2.381 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 6, n= 400, 402 | -2.11 Millimoles per liter (mmol/L) | Standard Deviation 2.451 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 12, n= 400, 402 | -2.10 Millimoles per liter (mmol/L) | Standard Deviation 2.59 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 18, n= 400, 402 | -1.74 Millimoles per liter (mmol/L) | Standard Deviation 2.704 |
| Liraglutide 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 | Week 1, n=386, 381 | -1.62 Millimoles per liter (mmol/L) | Standard Deviation 2.116 |
Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 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 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 considered in the treatment week if they had received at least one dose in that treatment week.
Time frame: Baseline, Weeks 4, 6, 12, 18 and 26
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albiglutide 50 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 12, n=398, 402 | -0.88 Percentage of HbA1c in the blood | Standard Deviation 0.824 |
| Albiglutide 50 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 6, n=398, 401 | -0.66 Percentage of HbA1c in the blood | Standard Deviation 0.566 |
| Albiglutide 50 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 18, n=398, 402 | -0.87 Percentage of HbA1c in the blood | Standard Deviation 0.921 |
| Albiglutide 50 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 4, n=387, 392 | -0.52 Percentage of HbA1c in the blood | Standard Deviation 0.481 |
| Albiglutide 50 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 26, n=398, 402 | -0.79 Percentage of HbA1c in the blood | Standard Deviation 0.968 |
| Liraglutide 1.8 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 26, n=398, 402 | -1.00 Percentage of HbA1c in the blood | Standard Deviation 0.969 |
| Liraglutide 1.8 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 6, n=398, 401 | -0.94 Percentage of HbA1c in the blood | Standard Deviation 0.569 |
| Liraglutide 1.8 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 12, n=398, 402 | -1.18 Percentage of HbA1c in the blood | Standard Deviation 0.798 |
| Liraglutide 1.8 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 18, n=398, 402 | -1.13 Percentage of HbA1c in the blood | Standard Deviation 0.904 |
| Liraglutide 1.8 mg | Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 | Week 4, n=387, 392 | -0.73 Percentage of HbA1c in the blood | Standard Deviation 0.447 |
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32
Number of participants who achieved HbA1c response levels of \<6.5% and \<7.0% at Week 32 were assessed. 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.
Time frame: Week 32
Population: ITT Population. Only those participants available at the indicated time point were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Albiglutide 50 mg | Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32 | HbA1c <7.0% | 168 Participants |
| Albiglutide 50 mg | Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32 | HbA1c <6.5% | 78 Participants |
| Liraglutide 1.8 mg | Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32 | HbA1c <7.0% | 208 Participants |
| Liraglutide 1.8 mg | Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32 | HbA1c <6.5% | 113 Participants |
Time to Hyperglycemia Rescue at Week 32
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) \>=280 milligram/decilitre (mg/dL) \>= Week 2 and \< Week 4, FPG \>=250 mg/dL \>= Week 4 and \<Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- \>= Week 12 and \<Week 26, or HbA1c ≥8.5% \>= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.
Time frame: Week 32
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albiglutide 50 mg | Time to Hyperglycemia Rescue at Week 32 | NA Weeks |
| Liraglutide 1.8 mg | Time to Hyperglycemia Rescue at Week 32 | NA Weeks |