Trial · Interventional
CompletedPhase 3Results postedRegistry dataJapan
1 trial · 1 completed · 1 with posted results
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT01733758Feb 2013 to Feb 2015
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.
Experimental
Albiglutide 30 mg weekly
Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
Experimental
Albiglutide 50 mg weekly
Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
Placebo comparator
Placebo
Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52
Active comparator
Liraglutide 0.9 mg daily
Subjects will be randomly assigned to open-label liraglutide for 52 weeks
Outcomes the sponsor listed as primary.
Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time frame · Baseline and Week 24
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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (\<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
Time frame · Baseline and Week 24
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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.
Change From Baseline in HbA1c at Week 52
Time frame · Baseline and Week 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 on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24
Time frame · Week 24
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as \<6.5% and \<7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52
Time frame · Week 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. Clinically meaningful levels of response in HbA1c are defined as \<6.5% and \<7.0%.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame · Baseline and Week 24
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time frame · Baseline and Week 52
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.
Change From Baseline in Body Weight at Week 24
Time frame · Baseline and Week 24
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.
Change From Baseline in Body Weight at Week 52
Time frame · Baseline and Week 52
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.
Time to Study Withdrawal Due to Hyperglycemia
Time frame · Baseline through Week 52
Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to \<Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to \<Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to \<Week 52, confirmed a second evaluation within 7 days.
Time to Study Withdrawal for Any Reason
Time frame · Baseline through Week 52
Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of HbA1c in the blood) | Spread |
|---|---|---|
| Placebo | 0.25 | 0.068 |
| Albiglutide 30 mg Weekly | -1.10 | 0.047 |
| Albiglutide 50 mg Weekly | -1.30 | 0.049 |
| Open-Label Liraglutide 0.9 mg Daily | not posted | – |
| Group | Value (Percentage of HbA1c in the blood) | Spread |
|---|---|---|
| Placebo | 8.16 | 0.877 |
| Albiglutide 30 mg Weekly | 8.06 | 0.783 |
| Albiglutide 50 mg Weekly | 8.15 | 0.825 |
| Open-Label Liraglutide 0.9 mg Daily | 8.07 | 0.787 |
| Group | Value (Percentage of HbA1c in the blood) | Spread |
|---|---|---|
| Placebo | -1.07 | 0.695 |
| Albiglutide 30 mg Weekly | -1.07 | 0.790 |
| Albiglutide 50 mg Weekly | -1.34 | 0.753 |
| Open-Label Liraglutide 0.9 mg Daily | -1.17 | 0.776 |
| Group | Value (Percentage of participants) |
|---|---|
| Placebo | 1 |
| Albiglutide 30 mg Weekly | 31 |
| Albiglutide 50 mg Weekly | 47 |
| Open-Label Liraglutide 0.9 mg Daily | 29 |
| Group | Value (Percentage of participants) |
|---|---|
| Placebo | 14 |
| Albiglutide 30 mg Weekly | 44 |
| Albiglutide 50 mg Weekly | 53 |
| Open-Label Liraglutide 0.9 mg Daily | 27 |
| Group | Value (Milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| Placebo | 159.3 | 37.07 |
| Albiglutide 30 mg Weekly | 157.1 | 33.81 |
| Albiglutide 50 mg Weekly | 158.7 | 32.82 |
| Open-Label Liraglutide 0.9 mg Daily | 157.2 | 31.22 |
| Group | Value (Milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| Placebo | 154.5 | 35.65 |
| Albiglutide 30 mg Weekly | 154.7 | 29.36 |
| Albiglutide 50 mg Weekly | 159.8 | 33.52 |
| Open-Label Liraglutide 0.9 mg Daily | 157.4 | 30.27 |
| Group | Value (Kilograms (kg)) | Spread |
|---|---|---|
| Placebo | 68.65 | 12.088 |
| Albiglutide 30 mg Weekly | 69.46 | 13.453 |
| Albiglutide 50 mg Weekly | 71.54 | 12.907 |
| Open-Label Liraglutide 0.9 mg Daily | 72.65 | 13.758 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo - Before Switch(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. | – | 0 / 77 | 33 / 77 |
| Placebo - After Switch(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52. | – | 0 / 65 | 24 / 65 |
| Albiglutide 30 mg WeeklyParticipants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52. | – | 5 / 160 | 85 / 160 |
| Albiglutide 50 mg WeeklyParticipants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52. | – | 6 / 150 | 76 / 150 |
| Open Label Liraglutide 0.9 mg DailyParticipants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52. | – | 0 / 103 | 46 / 103 |
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