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Safety and Efficacy of Albiglutide in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00849056
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : July 1, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: albiglutide
Drug: placebo

  Participant Flow

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 450 par. were screened; 310 par. were randomized, and 301 par. received >=1 treatment dose.

Reporting Groups
  Description
Placebo + Pioglitazone With or Without Metformin Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Albiglutide 30 mg + Pioglitazone With or Without Metformin Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Participant Flow for 2 periods

 Period 1:   Treatment Period (TP) (156 Weeks)
    Placebo + Pioglitazone With or Without Metformin   Albiglutide 30 mg + Pioglitazone With or Without Metformin
STARTED   151   150 
COMPLETED   88   100 
NOT COMPLETED   63   50 
Adverse Event                13                11 
Protocol Violation                3                6 
Noncompliance                3                3 
Lost to Follow-up                7                5 
Withdrawal by Subject                31                18 
Physician Decision                3                3 
Termination of Study/Site by GSK                1                4 
Calcitonin Out of Range                1                0 
Pregnancy                1                0 

Period 2:   Follow-up Period (FUP) (8 Weeks)
    Placebo + Pioglitazone With or Without Metformin   Albiglutide 30 mg + Pioglitazone With or Without Metformin
STARTED   149 [1]   149 [2] 
COMPLETED   122   124 
NOT COMPLETED   27   25 
Adverse Event                1                3 
Noncompliance                0                1 
Lost to Follow-up                14                9 
Withdrawal by Subject                9                7 
Physician Decision                1                1 
Termination of Study/Site by GSK                1                4 
Early Termination                1                0 
[1] Par. withdrawing from the TP could enter the FUP. Two par. did not participate in the FUP.
[2] Par. withdrawing from the TP could enter the FUP. One par. did not participate in the FUP.



  Baseline Characteristics

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 + Pioglitazone With or Without Metformin Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Albiglutide 30 mg + Pioglitazone With or Without Metformin Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Total Total of all reporting groups

Baseline Measures
   Placebo + Pioglitazone With or Without Metformin   Albiglutide 30 mg + Pioglitazone With or Without Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 151   150   301 
Age 
[Units: Years]
Mean (Standard Deviation) 		 54.9  (9.40)   55.2  (9.98)   55.0  (9.67) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      63  41.7%      58  38.7%      121  40.2% 
Male      88  58.3%      92  61.3%      180  59.8% 
Race/Ethnicity, Customized 
[Units: Participants]
 		     
African American/African Heritage   20   19   39 
American Indian or Alaskan Native   15   18   33 
Asian - Central/South Asian Heritage   1   2   3 
Asian - East Asian Heritage   2   3   5 
Asian - Japanese Heritage   1   1   2 
Asian - South East Asian Heritage   2   0   2 
Native Hawaiian or other Pacific Islander   2   1   3 
White - Arabic/North African Heritage   2   2   4 
White - White/Caucasian/European Heritage   106   104   210 


  Outcome Measures

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

2.  Secondary:   Change From Baseline in HbA1c at Weeks 104 and 156   [ Time Frame: Baseline and Weeks 104 and 156 ]
  Show Outcome Measure 2

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

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

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

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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

9.  Secondary:   Change From Baseline in Body Weight at Week 156   [ Time Frame: Baseline and Week 156 ]
  Show Outcome Measure 9


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849056     History of Changes
Other Study ID Numbers: 112755
First Submitted: February 19, 2009
First Posted: February 23, 2009
Results First Submitted: April 24, 2014
Results First Posted: July 1, 2014
Last Update Posted: January 9, 2017