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: April 30, 2015
Last verified: April 2015
  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:
  • Model-adjusted Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: BL 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 BL HbA1c value is defined as the last nonmissing value before the start of treatment. Change from BL was calculated as the value at Week 24 minus the value at BL. Based on analysis of covariance (ANCOVA): Change at Week 24=treatment (placebo, albiglutide 30 mg, albiglutide 50 mg)+BL HbA1c+prior diabetes therapy+age category (<65 years versus >=65 years). Par. who discontinued from study treatment before Week 24 had their last on treatment, post-BL HbA1c observation carried forward for the analysis. 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 BL, Week 24, and Change From BL at Week 24 [ Time Frame: BL 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 BL HbA1c value is defined as the last nonmissing value before the start of treatment. Change from BL was calculated as the value at Week 24 minus the value at BL. Par. who discontinued from study treatment before Week 24 had their last on-treatment, post-BL HbA1c observation carried forward for the summary. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.


Enrollment: 494
Study Start Date: February 2013
Study Completion Date: February 2015
Primary Completion Date: June 2014 (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/ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 74 Study Locations
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
Results First Received: April 2, 2015
Last Updated: April 30, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Albiglutide
Glucagon-Like Peptide 1
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 02, 2015