Safety and Efficacy of Albiglutide in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849056
First received: February 19, 2009
Last updated: May 29, 2014
Last verified: May 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
Drug: 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 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
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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 + 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  
Number of Participants  
[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]
     
Female     63     58     121  
Male     88     92     180  
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
  Show All Outcome Measures

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 ]


  Serious Adverse Events
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Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.
Additional Description SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.

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.

Serious Adverse Events
    Placebo + Pioglitazone With or Without Metformin     Albiglutide 30 mg + Pioglitazone With or Without Metformin  
Total, serious adverse events      
# participants affected / at risk     28/151 (18.54%)     15/150 (10.00%)  
Cardiac disorders      
Coronary artery disease † 1    
# participants affected / at risk     2/151 (1.32%)     2/150 (1.33%)  
Acute myocardial infarction † 1    
# participants affected / at risk     0/151 (0.00%)     2/150 (1.33%)  
Angina unstable † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Aortic valve incompetence † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Atrial fibrillation † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Cardiac failure † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Cardiomyopathy † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Coronary artery stenosis † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Myocardial infarction † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Sick sinus syndrome † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Gastrointestinal disorders      
Colonic fistula † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Diabetic gastroparesis † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Gastric ulcer † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Small intestinal obstruction † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
General disorders      
Chest pain † 1    
# participants affected / at risk     3/151 (1.99%)     0/150 (0.00%)  
Hepatobiliary disorders      
Cholecystitis acute † 1    
# participants affected / at risk     2/151 (1.32%)     0/150 (0.00%)  
Cholecystitis † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Infections and infestations      
Cellulitis † 1    
# participants affected / at risk     2/151 (1.32%)     1/150 (0.67%)  
Abscess limb † 1    
# participants affected / at risk     1/151 (0.66%)     1/150 (0.67%)  
Pneumonia † 1    
# participants affected / at risk     0/151 (0.00%)     2/150 (1.33%)  
Appendicitis perforated † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Diverticulitis † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Sinusitis † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Viral infection † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Vulval abscess † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Injury, poisoning and procedural complications      
Face injury † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Metabolism and nutrition disorders      
Obesity † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     2/151 (1.32%)     0/150 (0.00%)  
Osteoarthritis † 1    
# participants affected / at risk     1/151 (0.66%)     1/150 (0.67%)  
Bursitis † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Breast cancer stage I † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Lung cancer metastatic † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Metastases to liver † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Non-small cell lung cancer † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Prostate cancer metastatic † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Nervous system disorders      
Dizziness † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Pregnancy, puerperium and perinatal conditions      
Abortion spontaneous † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Psychiatric disorders      
Major depression † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Renal and urinary disorders      
Nephrolithiasis † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Renal colic † 1    
# participants affected / at risk     0/151 (0.00%)     1/150 (0.67%)  
Renal impairment † 1    
# participants affected / at risk     1/151 (0.66%)     0/150 (0.00%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     2/151 (1.32%)     0/150 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  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: NCT00849056     History of Changes
Other Study ID Numbers: 112755
Study First Received: February 19, 2009
Results First Received: April 24, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration