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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838916
First received: February 5, 2009
Last updated: May 22, 2014
Last verified: April 2014
Results First Received: April 17, 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
Drug: insulin glargine

  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 1060 par. were screened; 779 par. were randomized, and 745 par. received >=1 treatment dose.

Reporting Groups
  Description
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline 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)
    Albiglutide 30 mg + Metformin +/- Sulfonylurea     Insulin Glargine 10 Units + Metformin +/- Sulfonylurea  
STARTED     504     241  
COMPLETED     308     164  
NOT COMPLETED     196     77  
Adverse Event                 50                 11  
Protocol Violation                 12                 3  
Noncompliance                 21                 14  
Severe or Repeated Hypoglycaemia                 1                 0  
Lost to Follow-up                 19                 18  
Withdrawal by Subject                 81                 29  
Physician Decision                 6                 1  
Termination of Study/Site by GSK                 1                 0  
Missing                 3                 1  
Pregnancy                 2                 0  

Period 2:   Follow-up Period (8 Weeks)
    Albiglutide 30 mg + Metformin +/- Sulfonylurea     Insulin Glargine 10 Units + Metformin +/- Sulfonylurea  
STARTED     504 [1]   241 [1]
COMPLETED     408     190  
NOT COMPLETED     96     51  
Adverse Event                 10                 5  
Noncompliance                 6                 5  
Lost to Follow-up                 38                 22  
Did not Enter Follow-up Period                 7                 7  
Withdrawn from Follow-up Participation                 26                 12  
Physician Decision                 2                 0  
Termination of Study/Site by GSK                 2                 0  
Withdrawal by Subject                 2                 0  
Missing                 3                 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
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Albiglutide 30 mg + Metformin +/- Sulfonylurea     Insulin Glargine 10 Units + Metformin +/- Sulfonylurea     Total  
Number of Participants  
[units: participants]
  504     241     745  
Age  
[units: Years]
Mean ± Standard Deviation
  55.8  ± 9.33     54.7  ± 9.75     55.5  ± 9.48  
Gender  
[units: Participants]
     
Female     218     109     327  
Male     286     132     418  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     130     64     194  
American Indian or Alaskan Native     3     1     4  
Asian - Central/South Asian Heritage     7     5     12  
Asian - East Asian Heritage     2     1     3  
Asian - Japanese Heritage     0     1     1  
Asian - South East Asian Heritage     16     8     24  
Native Hawaiian or Other Pacific Islander     1     0     1  
White - Arabic/North African Heritage     7     2     9  
White - White/Caucasian/European Heritage     342     158     500  
Other - Central American Indian     1     0     1  
Other - Hispanic     0     1     1  
Other - Mexican     1     0     1  



  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 Week 156   [ Time Frame: Baseline 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 Fasting Plasma Glucose (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 52   [ Time Frame: Week 52 ]

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 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 Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Albiglutide Plasma Concentrations at Week 8 and Week 24   [ Time Frame: Weeks 8 and 24 ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Albiglutide Plasma Concentrations at Week 8 and Week 24
Measure Description Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.
Time Frame Weeks 8 and 24  
Safety Issue No  

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.
ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.

Reporting Groups
  Description
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Measured Values
    Albiglutide 30 mg + Metformin +/- Sulfonylurea  
Number of Participants Analyzed  
[units: participants]
  459  
Albiglutide Plasma Concentrations at Week 8 and Week 24  
[units: nanograms/milliliter¬†(ng/mL)]
Mean ± Standard Deviation
 
Week 8, Pre-dose, n=408     1642.83  ± 892.570  
Week 8, Post-dose, n=398     1911.35  ± 966.180  
Week 24, Pre-dose, n=416     2159.30  ± 1211.714  
Week 24, Post-dose, n=401     2748.15  ± 1503.945  

No statistical analysis provided for Albiglutide Plasma Concentrations at Week 8 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 by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00838916     History of Changes
Other Study ID Numbers: 112754
Study First Received: February 5, 2009
Results First Received: April 17, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration