Last updated: 11/07/2018 05:41:09

A monotherapy study to evaluate the efficacy and safety of 2 dose levels of albiglutide in Japanese subjects with type 2 diabetes mellitus (T2DM)

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GSK study ID
113121
See study documents
Clinicaltrials.gov ID
NCT01733758
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Model-adjusted change from Baseline in glycosylated hemoglobin (HbA1c) at Week 24

Timeframe: Baseline and Week 24

Mean HbA1c at Baseline, Week 24, and change from Baseline at Week 24

Timeframe: Baseline and Week 24

Secondary outcomes:

Change from Baseline in HbA1c at Week 52

Timeframe: 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

Timeframe: 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

Timeframe: Week 52

Change from Baseline in Fasting Plasma Glucose (FPG) at Week 24

Timeframe: Baseline and Week 24

Change from Baseline in Fasting Plasma Glucose (FPG) at Week 52

Timeframe: Baseline and Week 52

Change from Baseline in body weight at Week 24

Timeframe: Baseline and Week 24

Change from Baseline in body weight at Week 52

Timeframe: Baseline and Week 52

Time to study withdrawal due to hyperglycemia

Timeframe: Baseline through Week 52

Time to study withdrawal for any reason

Timeframe: Baseline through Week 52

Interventions:
  • Drug: Albiglutide 30 mg weekly
  • Drug: Albiglutide 50 mg weekly
  • Drug: Placebo
  • Drug: Liraglutide 0.9 mg daily
    • Enrollment:
    494
    Primary completion date:
    2014-12-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Nino A, Okuda I, Wilson T, Yue L, Nakajima H, Tsuboi M, Carr MC, Seino Y. RESUBMISSION: Weekly glucagon-like peptide-1 receptor agonist albiglutide as monotherapy improves glycemic parameters in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study. J Diabetes Investig. 2018;9(3):558-566.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    February 2013 to February 2015
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    20+ years
    Accepts healthy volunteers
    No
    • 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
    • History of type 1 diabetes mellitus
    • Female subject is pregnant, lactating, or <6 weeks postpartum•
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Tokyo, Japan, 125-0054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Osaka, Japan, 530-0004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fukushima, Japan, 960-0418
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Yamaguchi, Japan, 755-0047
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kagawa, Japan, 760-0076
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aichi, Japan, 456-0058
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-12-06
    Actual study completion date
    2015-23-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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