Dose Ranging Study of Albiglutide in Japanese Subjects

November 29, 2016 updated by: GlaxoSmithKline

A Dose Finding Study of GSK716155 Versus Placebo in the Treatment of Type 2 Diabetes Mellitus

This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) 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.

Detailed Description

This is a Phase IIb, randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging, superiority study evaluating the dose response, efficacy and safety of weekly and every other week subcutaneously injected GSK716155 (albiglutide) in subjects with type 2 diabetes mellitus.

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.
215

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 2

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, 466-0815
        • GSK Investigational Site
      • Ehime, Japan, 790-0067
        • GSK Investigational Site
      • Fukuoka, Japan, 810-0001
        • GSK Investigational Site
      • Fukuoka, Japan, 815-8555
        • GSK Investigational Site
      • Fukuoka, Japan, 819-0168
        • GSK Investigational Site
      • Fukuoka, Japan, 811-1346
        • GSK Investigational Site
      • Hiroshima, Japan, 731-0103
        • GSK Investigational Site
      • Hokkaido, Japan, 080-0010
        • GSK Investigational Site
      • Hokkaido, Japan, 080-0016
        • GSK Investigational Site
      • Hokkaido, Japan, 003-0023
        • GSK Investigational Site
      • Hokkaido, Japan, 044-0053
        • GSK Investigational Site
      • Hokkaido, Japan, 061-1395
        • GSK Investigational Site
      • Ibaraki, Japan, 311-0113
        • GSK Investigational Site
      • Ibaraki, Japan, 310-0826
        • GSK Investigational Site
      • Kagoshima, Japan, 891-0401
        • GSK Investigational Site
      • Kanagawa, Japan, 210-0852
        • GSK Investigational Site
      • Kanagawa, Japan, 235-0045
        • GSK Investigational Site
      • Kumamoto, Japan, 862-0976
        • GSK Investigational Site
      • Kumamoto, Japan, 866-0862
        • GSK Investigational Site
      • Miyagi, Japan, 980-0021
        • GSK Investigational Site
      • Miyagi, Japan, 985-0852
        • GSK Investigational Site
      • Nagasaki, Japan, 856-0831
        • GSK Investigational Site
      • Saitama, Japan, 355-0321
        • GSK Investigational Site
      • Saitama, Japan, 362-0021
        • GSK Investigational Site
      • Tochigi, Japan, 329-0433
        • GSK Investigational Site
      • Tochigi, Japan, 329-0101
        • GSK Investigational Site
      • Tokyo, Japan, 125-0054
        • GSK Investigational Site
      • Tokyo, Japan, 154-0015
        • GSK Investigational Site
      • Tokyo, Japan, 177-0041
        • GSK Investigational Site
      • Yamagata, Japan, 990-0885
        • 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD
  • BMI ≥18 kg/m2 and <35 kg/m2 at Screening
  • HbA1c between 7.0% and 10.0%, inclusive
  • Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
  • Female subjects of childbearing potential must be practicing adequate contraception .
  • Able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor.
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus
  • Uncorrected thyroid dysfunction
  • Previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening

  • Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:

    • Previous history of stroke or transient ischemic attack
    • Active, unstable coronary heart disease within the past six months before Screening
    • Documented myocardial infarction within one year before Screening
    • Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before Screening
    • Unstable angina
    • Clinically significant arrhythmia or valvular heart disease
    • Current heart failure NYHA class II to IV
    • Resting systolic pressure >160 mm Hg or diastolic pressure >95 mm Hg at Screening
    • ECG criteria at Screening
  • Heart rate: <40 and >110 bpm
  • PR interval: <120 and > 210 msec
  • QRS interval: <70 and >120 msec
  • QTc interval (Bazett): >450 msec or >480 msec with bundle branch block
  • Fasting triglyceride level >400 mg/dL at Screening
  • AST or ALT >2xULN, ALP and bilirubin >1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin <35% of total bilirubin)
  • If female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant

  • Has significant renal disease as manifested by one or more of the following:

    • Creatinine clearance at screening <60 mL/min (calculated by Cockcroft-Gault formula) at Screening
    • Known loss of a kidney either by surgical ablation, injury or disease level
  • A hemoglobinopathy that may affect determination of HbA1c level
  • History of treated diabetic gastroparesis
  • History of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function
  • Current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis.
  • Lipase and amylase at Screening > ULN
  • Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma
  • History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
  • Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening
  • Current and history of alcohol or substance abuse
  • Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant
  • Prior use of a GLP-1 analog
  • Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation
  • History of or family history of medullary carcinoma of the thyroid.
  • History of or family history of multiple endocrine neoplasia type 2
  • Receipt of any investigational drug within the 12 weeks 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.
Active Comparator: albiglutide 15mg weekly
once weekly subcutaneous injection of albiglutide 15mg
Biological: albiglutide
subcutaneous injection of albiglutide
Other Names:
  • placebo
  • albiglutide 30mg weekly
  • albiglutide 15mg weekly
  • albiglutide 30mg every other week
Active Comparator: albiglutide 30mg weekly
once weekly subcutaneous injection of albiglutide 30mg
Biological: albiglutide
subcutaneous injection of albiglutide
Other Names:
  • placebo
  • albiglutide 30mg weekly
  • albiglutide 15mg weekly
  • albiglutide 30mg every other week
Active Comparator: albiglutide 30mg every other week
subcutaneous injection of 30mg albiglutide every other week
Biological: albiglutide
subcutaneous injection of albiglutide
Other Names:
  • placebo
  • albiglutide 30mg weekly
  • albiglutide 15mg weekly
  • albiglutide 30mg every other week
Placebo Comparator: placebo
once weekly subcutaneous injection of placebo to match albiglutide
Biological: placebo
subcutaneous injection of placebo to match albiglutide

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
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
Time Frame: Baseline and Week 16
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 before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Baseline and Week 16

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 Weeks 4, 8, 12, and 16
Time Frame: Baseline; Week 4, Week 8, Week 12, and Week 16
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 before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Baseline; Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16
Time Frame: Baseline; Week 4, Week 8, Week 12, and Week 16
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Body Weight at Week 4, 8, 12, and 16
Time Frame: Baseline; Week 4, Week 8, Week 12, and Week 16
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.
Baseline; Week 4, Week 8, Week 12, and Week 16
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16
Time Frame: Week 4, Week 8, Week 12, and Week 16
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed.
Week 4, Week 8, Week 12, and Week 16
Mean Clearance of Albiglutide
Time Frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Mean Volume of Distribution of Albiglutide
Time Frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Mean Absorption Rate of Albiglutide
Time Frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
Time Frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24

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.

General Publications

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.
April 1, 2010

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.
May 1, 2011

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.
May 1, 2011

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).
February 12, 2010

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.
April 1, 2010

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.
April 2, 2010

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.
January 13, 2017

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.
November 29, 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.
November 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.
  • 110932

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: 110932
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: 110932
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: 110932
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: 110932
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: 110932
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 110932
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: 110932
    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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