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
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 and 490 par. received at least 1 dose of study treatment. The primary evaluation to Week 24 is reported here. Par. randomized to placebo were switched to albiglutide 30 mg weekly at Week 24. Data from the ongoing study to Week 52 will be reported by the end of August 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible par. entered a 2-week Screening Period; a 4- to 8-week Washout/Run-In Period; a 52-week Treatment Period, which included 24 weeks of treatment and evaluation for primary efficacy and safety, followed by an additional 28 weeks of treatment for additional efficacy and safety; and an 8-week Posttreatment Follow-Up Period.

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 (approved dosage 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     65 [1]   153 [1]   143 [1]   98 [1]
NOT COMPLETED     12     7     7     5  
Adverse Event                 3                 4                 4                 1  
Protocol Violation                 0                 1                 2                 2  
Persistent Hyperglycemia                 3                 1                 0                 0  
Withdrawal by Subject                 1                 1                 1                 2  
PI Decided for Safety Purpose                 1                 0                 0                 0  
New Antidiabetic Medication                 4                 0                 0                 0  
[1] These participants completed treatment through Week 24.



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

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


  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


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