Clinical Trial Details
| Trial ID: | L4113 |
| Source ID: | NCT01733758 |
| Associated Drug: | Albiglutide 30 Mg Weekly |
| Title: | A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01733758/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Albiglutide 30 mg weekly|DRUG: Albiglutide 50 mg weekly|DRUG: Placebo|DRUG: Liraglutide 0.9 mg daily |
| Outcome Measures: | Primary: Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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., Baseline and Week 24|Mean HbA1c at Baseline, Week 24, and Change From Baseline at 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., Baseline and Week 24 | Secondary: Change From Baseline in HbA1c at 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., Baseline and Week 52|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, 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., Week 24|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, 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%., Week 52|Change From Baseline in Fasting Plasma Glucose (FPG) at 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., Baseline and Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at 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., Baseline and Week 52|Change From Baseline in Body Weight at 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., Baseline and Week 24|Change From Baseline in Body Weight at 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., Baseline and Week 52|Time to Study Withdrawal Due to Hyperglycemia, 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., Baseline through Week 52|Time to Study Withdrawal for Any Reason, 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., Baseline through Week 52 |
| Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 494 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-02 |
| Completion Date: | 2015-02 |
| Results First Posted: | 2015-05-18 |
| Last Update Posted: | 2016-09-22 |
| Locations: | GSK Investigational Site, Aichi, 456-0058, Japan|GSK Investigational Site, Chiba, 263-0043, Japan|GSK Investigational Site, Ehime, 790-0067, Japan|GSK Investigational Site, Ehime, 792-0045, Japan|GSK Investigational Site, Ehime, 792-8586, Japan|GSK Investigational Site, Fukuoka, 810-0014, Japan|GSK Investigational Site, Fukuoka, 812-0053, Japan|GSK Investigational Site, Fukuoka, 815-8588, Japan|GSK Investigational Site, Fukuoka, 819-0168, Japan|GSK Investigational Site, Fukushima, 960-0418, Japan|GSK Investigational Site, Fukushima, 961-0416, Japan|GSK Investigational Site, Fukushima, 963-8851, Japan|GSK Investigational Site, Fukushima, 964-8501, Japan|GSK Investigational Site, Gunma, 370-3573, Japan|GSK Investigational Site, Gunma, 379-0116, Japan|GSK Investigational Site, Hiroshima, 731-0103, Japan|GSK Investigational Site, Hokkaido, 040-8585, Japan|GSK Investigational Site, Hokkaido, 062-0007, Japan|GSK Investigational Site, Hokkaido, 070-0002, Japan|GSK Investigational Site, Hokkaido, 072-0012, Japan|GSK Investigational Site, Hokkaido, 080-0010, Japan|GSK Investigational Site, Hokkaido, 080-0016, Japan|GSK Investigational Site, Hyogo, 670-0074, Japan|GSK Investigational Site, Ibaraki, 300-0835, Japan|GSK Investigational Site, Ibaraki, 300-1512, Japan|GSK Investigational Site, Ibaraki, 311-0113, Japan|GSK Investigational Site, Kagawa, 760-0017, Japan|GSK Investigational Site, Kagawa, 760-0076, Japan|GSK Investigational Site, Kagoshima, 890-0061, Japan|GSK Investigational Site, Kanagawa, 212-0024, Japan|GSK Investigational Site, Kanagawa, 232-0064, Japan|GSK Investigational Site, Kanagawa, 235-0045, Japan|GSK Investigational Site, Kanagawa, 238-0011, Japan|GSK Investigational Site, Kanagawa, 242-0004, Japan|GSK Investigational Site, Kanagawa, 253-0044, Japan|GSK Investigational Site, Kochi, 780-0088, Japan|GSK Investigational Site, Kumamoto, 862-0976, Japan|GSK Investigational Site, Kumamoto, 866-8660, Japan|GSK Investigational Site, Kumamoto, 867-0041, Japan|GSK Investigational Site, Kyoto, 600-8558, Japan|GSK Investigational Site, Kyoto, 601-1495, Japan|GSK Investigational Site, Miyagi, 980-0021, Japan|GSK Investigational Site, Miyagi, 985-0852, Japan|GSK Investigational Site, Nagano, 385-0022, Japan|GSK Investigational Site, Nagano, 399-0006, Japan|GSK Investigational Site, Nagano, 399-0036, Japan|GSK Investigational Site, Nara, 634-0007, Japan|GSK Investigational Site, Oita, 870-0039, Japan|GSK Investigational Site, Oita, 876-0851, Japan|GSK Investigational Site, Okinawa, 901-0243, Japan|GSK Investigational Site, Osaka, 530-0001, Japan|GSK Investigational Site, Osaka, 530-0004, Japan|GSK Investigational Site, Osaka, 530-0012, Japan|GSK Investigational Site, Osaka, 532-0026, Japan|GSK Investigational Site, Osaka, 536-0023, Japan|GSK Investigational Site, Osaka, 538-0044, Japan|GSK Investigational Site, Osaka, 577-0803, Japan|GSK Investigational Site, Saitama, 332-0012, Japan|GSK Investigational Site, Saitama, 350-0035, Japan|GSK Investigational Site, Saitama, 350-0851, Japan|GSK Investigational Site, Saitama, 354-0031, Japan|GSK Investigational Site, Saitama, 355-0321, Japan|GSK Investigational Site, Saitama, 358-0011, Japan|GSK Investigational Site, Shizuoka, 424-0855, Japan|GSK Investigational Site, Tochigi, 329-0433, Japan|GSK Investigational Site, Tokyo, 103-0002, Japan|GSK Investigational Site, Tokyo, 103-0027, Japan|GSK Investigational Site, Tokyo, 103-0028, Japan|GSK Investigational Site, Tokyo, 104-0031, Japan|GSK Investigational Site, Tokyo, 104-0061, Japan|GSK Investigational Site, Tokyo, 125-0054, Japan|GSK Investigational Site, Tokyo, 136-0073, Japan|GSK Investigational Site, Tokyo, 143-0015, Japan|GSK Investigational Site, Yamaguchi, 755-0047, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01733758 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|