A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00976391
First received: September 11, 2009
Last updated: July 31, 2014
Last verified: June 2014
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: albiglutide + insulin glargine
Drug: insulin glargine + preprandial lispro insulin

  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 4-8 week Run-in/Stabilization Period were then randomized to a 52-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 920 par. were screened; 586 par. were randomized, and 566 par. received >=1 treatment dose.

Reporting Groups
  Description
Albiglutide 30 mg With Insulin Glargine Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
Preprandial Lispro Insulin With Insulin Glargine Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.

Participant Flow for 2 periods

Period 1:   Treatment Period (52 Weeks)
    Albiglutide 30 mg With Insulin Glargine     Preprandial Lispro Insulin With Insulin Glargine  
STARTED     285     281  
COMPLETED     243     242  
NOT COMPLETED     42     39  
Adverse Event                 16                 2  
Protocol Violation                 1                 1  
Noncompliance                 4                 4  
Lost to Follow-up                 10                 8  
Withdrawal by Subject                 9                 19  
Physician Decision                 1                 1  
Termination of Study/Site by GSK                 0                 4  
Pregnancy                 1                 0  

Period 2:   Follow-up Period (8 Weeks)
    Albiglutide 30 mg With Insulin Glargine     Preprandial Lispro Insulin With Insulin Glargine  
STARTED     285     281  
COMPLETED     256     247  
NOT COMPLETED     29     34  
Adverse Event                 3                 1  
Noncompliance                 2                 2  
Lost to Follow-up                 14                 12  
Did not Entered Follow-up                 6                 8  
Withdrawal by Subject                 4                 7  
Termination of Study/Site by GSK                 0                 4  



  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.
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Reporting Groups
  Description
Albiglutide 30 mg With Insulin Glargine Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
Preprandial Lispro Insulin With Insulin Glargine Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Albiglutide 30 mg With Insulin Glargine     Preprandial Lispro Insulin With Insulin Glargine     Total  
Number of Participants  
[units: participants]
  285     281     566  
Age  
[units: Years]
Mean ± Standard Deviation
  54.8  ± 9.10     56.3  ± 8.87     55.6  ± 9.01  
Gender  
[units: Participants]
     
Female     153     145     298  
Male     132     136     268  
Race/Ethnicity, Customized [1]
[units: Participants]
     
African American/African Heritage     39     34     73  
American Indian or Alaskan Native     29     20     49  
Asian - Central/South Asian Heritage     17     17     34  
Asian - East Asian Heritage     15     17     32  
Asian - South East Asian Heritage     16     16     32  
Native Hawaiian or Other Pacific Islander     1     3     4  
White - Arabic/North African Heritage     2     3     5  
White - White/Caucasian/European Heritage     174     171     345  
Other-Black     1     0     1  
Other-Native American     0     1     1  
[1] A participant may have been counted in more than 1 category.



  Outcome Measures
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1.  Primary:   Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26   [ Time Frame: Baseline and Week 26 ]

2.  Secondary:   Change From Baseline in HbA1c at Weeks 36, 48 and 52   [ Time Frame: Baseline and Weeks 36, 48 and 52 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26   [ Time Frame: Baseline and Week 26 ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52   [ Time Frame: Baseline and Weeks 36, 48 and 52 ]

5.  Secondary:   Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26   [ Time Frame: Week 26 ]

6.  Secondary:   Time to Hyperglycemia Rescue   [ Time Frame: From the start of study medication until the end of the treatment (up to Week 52) ]

7.  Secondary:   Change From Baseline in Body Weight at Week 26   [ Time Frame: Baseline and Week 26 ]

8.  Secondary:   Change From Baseline in Body Weight at Weeks 36, 48 and 52   [ Time Frame: Baseline and Weeks 36, 48 and 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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00976391     History of Changes
Other Study ID Numbers: 108486
Study First Received: September 11, 2009
Results First Received: May 1, 2014
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration