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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Albiglutide 30 mg weekly
Drug: Albiglutide 50 mg weekly
Drug: Placebo
Drug: Liraglutide 0.9 mg daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 475
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albiglutide 30 mg weekly
Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
Drug: Albiglutide 30 mg weekly
Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
Drug: Placebo
Albiglutide matching placebo will be available as a pen injector
Experimental: Albiglutide 50 mg weekly
Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
Drug: Albiglutide 50 mg weekly
Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
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
Drug: Placebo
Albiglutide matching placebo will be available as a pen injector
Active Comparator: Liraglutide 0.9 mg daily
Subjects will be randomly assigned to open-label liraglutide for 52 weeks
Drug: Liraglutide 0.9 mg daily
Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733758

Locations
Japan
GSK Investigational Site
Gunma, Japan, 370-3573
GSK Investigational Site
Tochigi, Japan, 329-0433
GSK Investigational Site
Tokyo, Japan, 103-0027
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01733758     History of Changes
Other Study ID Numbers: 113121
Study First Received: November 21, 2012
Last Updated: December 5, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:
albiglutide
Japanese
GSK716155
Type 2 diabetes mellitus
glucagon-like peptide 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2014