A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01733758
First received: November 21, 2012
Last updated: December 10, 2015
Last verified: October 2015

November 21, 2012
December 10, 2015
February 2013
June 2014   (final data collection date for primary outcome measure)
  • Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 at Week 24 of glycosylated hemoglobin (HbA1c). [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
The HbA1c will be assessed to compare two different doses of albiglutide with placebo. Change from baseline will be calculated as: HbA1c value at Week 24 minus HbA1c value at Baseline
Complete list of historical versions of study NCT01733758 on ClinicalTrials.gov Archive Site
  • Change From Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Change from baseline in HbA1c over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
    HbA1c will be assessed through Week 52 to compare albiglutide and placebo.
  • The proportion of subjects at HbA1c goals of <6.5% and <7.0% over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
    The proportion of subjects at HbA1c <6.5% and ,7.0% through Week 52 to compare albiglutide and placebo.
  • Change from Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
    FPG will be assessed through Week 52 comparing albiglutide versus placebo
  • Change from baseline in body weight over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
    Body weight will be assessed through Week 52 to compare albiglutide and placebo.
  • Time to withdrawal from randomly assigned treatment for any reason, and time to withdrawal from randomly assigned treatment due to hyperglycemia over time [ Time Frame: Baseline to end of treatment (Week 52) ] [ Designated as safety issue: No ]
    Time to study treatment withdrawal will be assessed through Week 52 for any reason and for hyperglycemia to compare albiglutide and placebo.
  • Number of participants with adverse events [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    Comparison of number of participants with adverse events after treatment with albiglutide and placebo
Not Provided
Not Provided
 
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Albiglutide 30 mg weekly
    Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
  • Drug: Albiglutide 50 mg weekly
    Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
  • Drug: Placebo
    Albiglutide matching placebo will be available as a pen injector
  • Drug: Liraglutide 0.9 mg daily
    Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose
  • Experimental: Albiglutide 30 mg weekly
    Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
    Interventions:
    • Drug: Albiglutide 30 mg weekly
    • Drug: Placebo
  • Experimental: Albiglutide 50 mg weekly
    Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
    Intervention: Drug: Albiglutide 50 mg weekly
  • 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
    Intervention: Drug: Placebo
  • Active Comparator: Liraglutide 0.9 mg daily
    Subjects will be randomly assigned to open-label liraglutide for 52 weeks
    Intervention: Drug: Liraglutide 0.9 mg daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
494
February 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
  • Body mass index (BMI) 17 to 40 kg/ m^2 inclusive
  • Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
  • Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion Criteria:

  • History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or <6 weeks postpartum•
  • Clinically significant cardiovascular and/or cerebrovascular disease
  • Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
  • Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
  • Prior use of a TZD or GLP-1R agonist within 4 months before Screening
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01733758
113121
Yes
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP