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

August 12, 2016 updated by: GlaxoSmithKline

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
494

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, 456-0058
        • GSK Investigational Site
      • Chiba, Japan, 263-0043
        • GSK Investigational Site
      • Ehime, Japan, 792-8586
        • GSK Investigational Site
      • Ehime, Japan, 790-0067
        • GSK Investigational Site
      • Ehime, Japan, 792-0045
        • GSK Investigational Site
      • Fukuoka, Japan, 819-0168
        • GSK Investigational Site
      • Fukuoka, Japan, 810-0014
        • GSK Investigational Site
      • Fukuoka, Japan, 815-8588
        • GSK Investigational Site
      • Fukuoka, Japan, 812-0053
        • GSK Investigational Site
      • Fukushima, Japan, 960-0418
        • GSK Investigational Site
      • Fukushima, Japan, 963-8851
        • GSK Investigational Site
      • Fukushima, Japan, 961-0416
        • GSK Investigational Site
      • Fukushima, Japan, 964-8501
        • GSK Investigational Site
      • Gunma, Japan, 370-3573
        • GSK Investigational Site
      • Gunma, Japan, 379-0116
        • GSK Investigational Site
      • Hiroshima, Japan, 731-0103
        • GSK Investigational Site
      • Hokkaido, Japan, 040-8585
        • GSK Investigational Site
      • Hokkaido, Japan, 070-0002
        • GSK Investigational Site
      • Hokkaido, Japan, 062-0007
        • GSK Investigational Site
      • Hokkaido, Japan, 072-0012
        • GSK Investigational Site
      • Hokkaido, Japan, 080-0010
        • GSK Investigational Site
      • Hokkaido, Japan, 080-0016
        • GSK Investigational Site
      • Hyogo, Japan, 670-0074
        • GSK Investigational Site
      • Ibaraki, Japan, 311-0113
        • GSK Investigational Site
      • Ibaraki, Japan, 300-0835
        • GSK Investigational Site
      • Ibaraki, Japan, 300-1512
        • GSK Investigational Site
      • Kagawa, Japan, 760-0076
        • GSK Investigational Site
      • Kagawa, Japan, 760-0017
        • GSK Investigational Site
      • Kagoshima, Japan, 890-0061
        • GSK Investigational Site
      • Kanagawa, Japan, 212-0024
        • GSK Investigational Site
      • Kanagawa, Japan, 232-0064
        • GSK Investigational Site
      • Kanagawa, Japan, 235-0045
        • GSK Investigational Site
      • Kanagawa, Japan, 253-0044
        • GSK Investigational Site
      • Kanagawa, Japan, 238-0011
        • GSK Investigational Site
      • Kanagawa, Japan, 242-0004
        • GSK Investigational Site
      • Kochi, Japan, 780-0088
        • GSK Investigational Site
      • Kumamoto, Japan, 862-0976
        • GSK Investigational Site
      • Kumamoto, Japan, 867-0041
        • GSK Investigational Site
      • Kumamoto, Japan, 866-8660
        • GSK Investigational Site
      • Kyoto, Japan, 601-1495
        • GSK Investigational Site
      • Kyoto, Japan, 600-8558
        • GSK Investigational Site
      • Miyagi, Japan, 980-0021
        • GSK Investigational Site
      • Miyagi, Japan, 985-0852
        • GSK Investigational Site
      • Nagano, Japan, 399-0006
        • GSK Investigational Site
      • Nagano, Japan, 399-0036
        • GSK Investigational Site
      • Nagano, Japan, 385-0022
        • GSK Investigational Site
      • Nara, Japan, 634-0007
        • GSK Investigational Site
      • Oita, Japan, 870-0039
        • GSK Investigational Site
      • Oita, Japan, 876-0851
        • GSK Investigational Site
      • Okinawa, Japan, 901-0243
        • GSK Investigational Site
      • Osaka, Japan, 530-0012
        • GSK Investigational Site
      • Osaka, Japan, 530-0001
        • GSK Investigational Site
      • Osaka, Japan, 577-0803
        • GSK Investigational Site
      • Osaka, Japan, 536-0023
        • GSK Investigational Site
      • Osaka, Japan, 538-0044
        • GSK Investigational Site
      • Osaka, Japan, 532-0026
        • GSK Investigational Site
      • Osaka, Japan, 530-0004
        • GSK Investigational Site
      • Saitama, Japan, 332-0012
        • GSK Investigational Site
      • Saitama, Japan, 350-0035
        • GSK Investigational Site
      • Saitama, Japan, 350-0851
        • GSK Investigational Site
      • Saitama, Japan, 354-0031
        • GSK Investigational Site
      • Saitama, Japan, 355-0321
        • GSK Investigational Site
      • Saitama, Japan, 358-0011
        • GSK Investigational Site
      • Shizuoka, Japan, 424-0855
        • GSK Investigational Site
      • Tochigi, Japan, 329-0433
        • GSK Investigational Site
      • Tokyo, Japan, 103-0027
        • GSK Investigational Site
      • Tokyo, Japan, 103-0028
        • GSK Investigational Site
      • Tokyo, Japan, 125-0054
        • GSK Investigational Site
      • Tokyo, Japan, 104-0031
        • GSK Investigational Site
      • Tokyo, Japan, 103-0002
        • GSK Investigational Site
      • Tokyo, Japan, 143-0015
        • GSK Investigational Site
      • Tokyo, Japan, 136-0073
        • GSK Investigational Site
      • Tokyo, Japan, 104-0061
        • GSK Investigational Site
      • Yamaguchi, Japan, 755-0047
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time Frame: Baseline and Week 24
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.
Baseline and Week 24
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
Time Frame: Baseline and Week 24
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.
Baseline and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 52
Time Frame: Baseline and Week 52
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.
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
Time Frame: Week 24
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.
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
Time Frame: Week 52
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%.
Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time Frame: Baseline and Week 24
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.
Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time Frame: Baseline and Week 52
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.
Baseline and Week 52
Change From Baseline in Body Weight at Week 24
Time Frame: Baseline and Week 24
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.
Baseline and Week 24
Change From Baseline in Body Weight at Week 52
Time Frame: Baseline and Week 52
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.
Baseline and Week 52
Time to Study Withdrawal Due to Hyperglycemia
Time Frame: Baseline through Week 52
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.
Baseline through Week 52
Time to Study Withdrawal for Any Reason
Time Frame: Baseline through Week 52
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.
Baseline through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 113121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Dataset Specification
    Information identifier: 113121
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: 113121
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 113121
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 113121
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: 113121
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 113121
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: 113121
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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