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A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00839527
First received: February 5, 2009
Last updated: May 29, 2014
Last verified: May 2014
Results First Received: April 24, 2014  
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: placebo to match albiglutide
Biological: albiglutide
Drug: metformin
Drug: glimepiride
Drug: pioglitazone
Drug: placebo to match pioglitazone

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants (par.) who met eligibility criteria and completed a 6- to 8-week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 992 par. were screened; 685 par. were randomized, and 663 par. received >=1 treatment dose.

Reporting Groups
  Description
Placebo + Metformin + Glimepiride Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Pioglitazone + Metformin + Glimepiride Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Albiglutide + Metformin + Glimepiride Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Participant Flow for 2 periods

Period 1:   Treatment Period (TP) (156 Weeks)
    Placebo + Metformin + Glimepiride     Pioglitazone + Metformin + Glimepiride     Albiglutide + Metformin + Glimepiride  
STARTED     115     277     271  
COMPLETED     55     159     152  
NOT COMPLETED     60     118     119  
Adverse Event                 11                 29                 22  
Protocol Violation                 4                 7                 1  
Noncompliance                 5                 6                 16  
Lost to Follow-up                 3                 12                 7  
Withdrawal by Subject                 32                 46                 64  
Physician Decision                 1                 6                 1  
Termination of Site by Sponsor                 3                 8                 5  
Missing                 0                 1                 0  
Persistant Elevated HbA1c Results                 0                 0                 1  
Pregnancy                 0                 1                 1  
Site Closed                 1                 2                 0  
Sponsor Decision on Blinding                 0                 0                 1  

Period 2:   Follow-up Period (FUP) (8 Weeks)
    Placebo + Metformin + Glimepiride     Pioglitazone + Metformin + Glimepiride     Albiglutide + Metformin + Glimepiride  
STARTED     114 [1]   273 [2]   266 [3]
COMPLETED     86     217     204  
NOT COMPLETED     28     56     62  
Adverse Event                 1                 2                 1  
Noncompliance                 1                 0                 5  
Lost to Follow-up                 8                 20                 29  
Withdrawal by Subject                 12                 21                 19  
Physician Decision                 0                 0                 1  
Termination of Study by Sponsor                 3                 10                 5  
Informed Consent Recalled by Participant                 1                 0                 0  
Investigator Closed Study at Site                 1                 0                 0  
Site Closed                 0                 1                 0  
Site Closing and Withdrew Consent                 1                 0                 1  
Unable to Complete Follow-up                 0                 1                 0  
Missing Follow-up Status                 0                 1                 1  
[1] Par. withdrawing from the TP could enter the FUP. One par. did not participate in the FUP.
[2] Par. withdrawing from the TP could enter the FUP. Four par. did not participate in the FUP.
[3] Par. withdrawing from the TP could enter the FUP. Five par. did not participate in the FUP.



  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.
No text entered.

Reporting Groups
  Description
Placebo + Metformin + Glimepiride Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Pioglitazone + Metformin + Glimepiride Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Albiglutide + Metformin + Glimepiride Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Placebo + Metformin + Glimepiride     Pioglitazone + Metformin + Glimepiride     Albiglutide + Metformin + Glimepiride     Total  
Number of Participants  
[units: participants]
  115     277     271     663  
Age  
[units: Years]
Mean ± Standard Deviation
  55.7  ± 9.59     55.7  ± 9.39     54.5  ± 9.47     55.2  ± 9.46  
Gender  
[units: Participants]
       
Female     45     129     136     310  
Male     70     148     135     353  
Race/Ethnicity, Customized  
[units: Participants]
       
African American/African Heritage     10     24     34     68  
American Indian or Alaskan Native     9     10     22     41  
Asian - Central/South Asian Heritage     6     6     8     20  
Asian - East Asian Heritage     2     8     12     22  
Asian - Japanese Heritage     0     1     2     3  
Asian - South East Asian Heritage     7     24     14     45  
Native Hawaiian or Other Pacific Islander     1     1     0     2  
White - Arabic/North African Heritage     1     2     2     5  
White - White/Caucasian/European Heritage     79     201     176     456  
Mexican American     0     0     1     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Change From Baseline in HbA1c at Week 104 and Week 156   [ Time Frame: Baseline, Week 104, and Week 156 ]

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

4.  Secondary:   Change From Baseline in FPG at Week 104 and Week 156   [ Time Frame: Baseline, Week 104, and Week 156 ]

5.  Secondary:   Time to Hyperglycemia Rescue   [ Time Frame: From the start of study medication until the end of the treatment (up to Week 156) ]

6.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52   [ Time Frame: Week 52 ]

7.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156   [ Time Frame: Week 156 ]

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

9.  Secondary:   Change From Baseline in Body Weight at Week 104 and Week 156   [ Time Frame: Baseline, Week 104, and Week 156 ]


  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
No text entered.


  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 by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00839527     History of Changes
Other Study ID Numbers: 112757
Study First Received: February 5, 2009
Results First Received: April 24, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration