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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: August 12, 2016
Last verified: August 2016
Results First Received: April 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Albiglutide 30 mg weekly
Drug: Albiglutide 50 mg weekly
Drug: Placebo
Drug: Liraglutide 0.9 mg daily

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 494 participants (par.) were randomized to one of the four treatment groups – placebo (switched to albiglutide 30 mg at Week 24), albiglutide 30 mg, albiglutide 50 mg, liraglutide (open label), 490 par. took at least one dose of study drug (Safety Population). All 490 par. were included in Intent-to-Treat Population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52.
Albiglutide 30 mg Weekly Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Albiglutide 50 mg Weekly Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Open Label Liraglutide 0.9 mg Daily Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.

Participant Flow:   Overall Study
    Placebo   Albiglutide 30 mg Weekly   Albiglutide 50 mg Weekly   Open Label Liraglutide 0.9 mg Daily
STARTED   77   160   150   103 
COMPLETED   62   148   135   95 
NOT COMPLETED   15   12   15   8 
Adverse Event                5                7                8                1 
Withdrawal by Subject                1                1                5                3 
Persistent Hyperglycemia                3                2                0                0 
Protocol Violation                0                1                2                2 
Non-compliance                1                0                0                0 
Intro of New Anti-Diabetic Medication                4                0                0                1 
Inv Decision, HbA1c not controlled                1                1                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are presented for the Safety Population.

Reporting Groups
  Description
Placebo Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Albiglutide 30 mg Weekly Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Albiglutide 50 mg Weekly Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Open Label Liraglutide 0.9 mg Daily Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Total Total of all reporting groups

Baseline Measures
   Placebo   Albiglutide 30 mg Weekly   Albiglutide 50 mg Weekly   Open Label Liraglutide 0.9 mg Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   160   150   103   490 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.3  (11.27)   59.6  (9.00)   57.7  (9.51)   58.4  (9.72)   58.4  (9.70) 
Gender 
[Units: Participants]
         
Female   25   35   36   22   118 
Male   52   125   114   81   372 
Race/Ethnicity, Customized 
[Units: Participants]
         
Asian - Japanese Heritage   77   160   150   103   490 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:   Change From Baseline in HbA1c at Week 52   [ Time Frame: Baseline and Week 52 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52   [ Time Frame: Baseline and Week 52 ]

8.  Secondary:   Change From Baseline in Body Weight at Week 24   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:   Change From Baseline in Body Weight at Week 52   [ Time Frame: Baseline and Week 52 ]

10.  Secondary:   Time to Study Withdrawal Due to Hyperglycemia   [ Time Frame: Baseline through Week 52 ]

11.  Secondary:   Time to Study Withdrawal for Any Reason   [ Time Frame: Baseline through Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



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: August 12, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency