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Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849017
First received: February 19, 2009
Last updated: May 29, 2014
Last verified: April 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: Biological: albiglutide
Biological: albiglutide uptitration
Biological: placebo

  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 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 479 par. were screened; 309 par. were randomized, and 301 par. received >=1 treatment dose.

Reporting Groups
  Description
Placebo Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Albiglutide 30 mg Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Albiglutide 50 mg Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.

Participant Flow for 2 periods

Period 1:   Treatment Period (156 Weeks)
    Placebo     Albiglutide 30 mg     Albiglutide 50 mg  
STARTED     101     101     99  
COMPLETED     58     68     57  
NOT COMPLETED     43     33     42  
Adverse Event                 5                 6                 15  
Noncompliance                 3                 3                 4  
Lost to Follow-up                 10                 7                 8  
Withdrawal by Subject                 18                 14                 11  
Physician Decision                 0                 2                 1  
Termination of Study/ Site by GSK                 3                 1                 1  
Increased Calcitonin                 1                 0                 0  
Physician Discontinued-Thrombocytopenia                 1                 0                 0  
Participant Moved to Africa                 1                 0                 0  
Pregnancy                 1                 0                 1  
Participant Decided to Move Out of State                 0                 0                 1  

Period 2:   Follow-up Period (8 Weeks)
    Placebo     Albiglutide 30 mg     Albiglutide 50 mg  
STARTED     101 [1]   101 [1]   99 [1]
COMPLETED     76     83     74  
NOT COMPLETED     25     18     25  
Adverse Event                 1                 0                 0  
Noncompliance                 2                 1                 0  
Lost to Follow-up                 13                 12                 16  
Did Not Enter Follow-up Period                 1                 1                 4  
Withdrawal by Subject                 4                 2                 3  
Physician Decision                 0                 1                 1  
Termination of Study/ Site by GSK                 3                 1                 1  
Participant Relocating to Africa                 1                 0                 0  
[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 Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Albiglutide 30 mg Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Albiglutide 50 mg Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Placebo     Albiglutide 30 mg     Albiglutide 50 mg     Total  
Number of Participants  
[units: participants]
  101     101     99     301  
Age  
[units: Years]
Mean ± Standard Deviation
  53.1  ± 11.68     53.6  ± 10.89     52.0  ± 11.75     52.9  ± 11.43  
Gender  
[units: Participants]
       
Female     43     43     49     135  
Male     58     58     50     166  
Race/Ethnicity, Customized  
[units: Participants]
       
African American/African Heritage     14     10     14     38  
American Indian or Alaskan Native     3     1     1     5  
Asian - Central/South Asian Heritage     0     1     1     2  
Asian - East Asian Heritage     2     0     0     2  
Asian - Japanese Heritage     1     0     0     1  
Asian - South East Asian Heritage     2     0     0     2  
Native Hawaiian or Other Pacific Islander     2     2     2     6  
White - Arabic/North African Heritage     0     2     3     5  
White - White/Caucasian/European Heritage     77     85     78     240  



  Outcome Measures
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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 Weeks 104 and 156   [ Time Frame: Baseline and Weeks 104 and 156 ]

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

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

5.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156   [ Time Frame: Baseline and 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 156   [ Time Frame: Baseline and Week 156 ]

10.  Secondary:   Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC   [ Time Frame: Baseline and Week 52 ]

12.  Secondary:   Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC   [ Time Frame: Baseline and Week 52 ]

13.  Secondary:   Albiglutide Plasma Concentration at Weeks 8 and 24   [ Time Frame: Weeks 8 and 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 by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849017     History of Changes
Other Study ID Numbers: 112756
Study First Received: February 19, 2009
Results First Received: April 24, 2014
Last Updated: May 29, 2014
Health Authority: South Africa: Medicines Control Council
Mexico: Ministry of Health
United States: Food and Drug Administration