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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01733758
First received: November 21, 2012
Last updated: December 5, 2013
Last verified: November 2013

November 21, 2012
December 5, 2013
February 2013
April 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01733758 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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.
 
Active, not recruiting
475
April 2015
April 2015   (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/ m2 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
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2013

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