Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838903
First received: February 5, 2009
Last updated: May 29, 2014
Last verified: May 2014
Results First Received: April 17, 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: Biological: albiglutide
Drug: sitagliptin
Drug: glimepiride
Drug: metformin

  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
Eligible participants (par.) entered a 2-week Screening Period, a 4-week Run-in/Stabilization Period, a 156-week Treatment Period, and a 8-week post-treatment Follow-up Period. A total of 1525 par. were screened, 1049 were randomized and 1012 par. received at least 1 dose of study treatment.

Reporting Groups
  Description
Placebo Plus Metformin Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Sitagliptin 100 mg Plus Metformin Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Glimepiride 2 mg Plus Metformin Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Albiglutide 30 mg Plus Metformin Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Participant Flow for 2 periods

Period 1:   Treatment Period (156 Weeks)
    Placebo Plus Metformin     Sitagliptin 100 mg Plus Metformin     Glimepiride 2 mg Plus Metformin     Albiglutide 30 mg Plus Metformin  
STARTED     101     302     307     302  
Missing Active Treatment Status     1     0     0     0  
COMPLETED     55     190     191     192  
NOT COMPLETED     46     112     116     110  
Adverse Event                 5                 13                 17                 25  
Protocol Violation                 1                 6                 6                 5  
Noncompliance                 9                 13                 12                 6  
Severe or Repeated Hypoglycaemia                 0                 0                 1                 0  
Lost to Follow-up                 4                 16                 15                 13  
Withdrawal by Subject                 20                 55                 56                 53  
Physician Decision                 1                 2                 1                 2  
Termination of Study/Site by GSK                 3                 5                 5                 4  
Patient and PI Decision to Discontinue                 0                 1                 0                 0  
Poor Glycemic Control                 0                 0                 0                 1  
Poor Therapeutic Response                 1                 0                 0                 0  
Pregnancy                 0                 0                 1                 0  
PI Decided for Safety Purpose                 0                 0                 1                 0  
Site closed                 0                 0                 1                 0  
Site Closed and Subject Withdrew Consent                 1                 0                 0                 0  
Subject Migrated to Other Country                 0                 1                 0                 1  
Missing Active Treatment Status                 1                 0                 0                 0  

Period 2:   Follow-up Period (8 Weeks)
    Placebo Plus Metformin     Sitagliptin 100 mg Plus Metformin     Glimepiride 2 mg Plus Metformin     Albiglutide 30 mg Plus Metformin  
STARTED     101 [1]   302 [1]   307 [1]   302 [1]
COMPLETED     75     237     243     244  
NOT COMPLETED     26     65     64     58  
Adverse Event                 0                 0                 3                 1  
Noncompliance                 2                 8                 5                 5  
Lost to Follow-up                 6                 28                 22                 24  
Did Not Enter Follow-up Period                 5                 7                 12                 7  
Subject Withdrawn from Follow-up                 8                 13                 14                 14  
Physician Decision                 1                 1                 1                 1  
Termination of Study/Site by GSK                 3                 4                 6                 4  
ICF Withdrawn                 0                 1                 0                 0  
Investigator Stopped Study at Site                 0                 1                 0                 0  
Subject Moved out of Town                 0                 0                 0                 1  
Missing                 1                 2                 1                 1  
[1] Participants withdrawing from the Treatment Period entered the Follow-up Period.



  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 Plus Metformin Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Sitagliptin 100 mg Plus Metformin Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Glimepiride 2 mg Plus Metformin Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Albiglutide 30 mg Plus Metformin Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Placebo Plus Metformin     Sitagliptin 100 mg Plus Metformin     Glimepiride 2 mg Plus Metformin     Albiglutide 30 mg Plus Metformin     Total  
Number of Participants  
[units: participants]
  101     302     307     302     1012  
Age  
[units: Years]
Mean ± Standard Deviation
  56.1  ± 10.01     54.3  ± 9.81     54.4  ± 9.97     54.3  ± 10.12     54.5  ± 9.97  
Gender  
[units: Participants]
         
Female     51     163     149     167     530  
Male     50     139     158     135     482  
Race/Ethnicity, Customized [1]
[units: Participants]
         
African American/African Heritage     23     35     39     53     150  
American Indian or Alaskan Native     9     22     25     17     73  
Asian - Central/South Asian Heritage     1     7     3     2     13  
Asian - East Asian Heritage     0     2     3     5     10  
Asian - Japanese Heritage     1     0     1     0     2  
Asian - South East Asian Heritage     3     11     9     11     34  
Native Hawaiian or Other Pacific Islander     1     0     0     1     2  
White - Arabic/North African Heritage     0     1     9     3     13  
White - White/Caucasian/European Heritage     64     225     220     214     723  
[1] A participant may have been counted in more than one category.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104   [ Time Frame: Baseline and Week 104 ]

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

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104   [ Time Frame: Baseline and Week 104 ]

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

5.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104   [ Time Frame: Week 104 ]

6.  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 ]

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

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

9.  Secondary:   Change From Baseline in Body Weight at Week 156   [ Time Frame: Baseline 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
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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: NCT00838903     History of Changes
Other Study ID Numbers: 112753
Study First Received: February 5, 2009
Results First Received: April 17, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration