Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00518115
First received: August 17, 2007
Last updated: June 19, 2014
Last verified: May 2014
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Drug: Albiglutide (GSK716155) or exenatide

  Participant Flow
  Hide 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
A total of 361 participants were randomized into the study; however, only 356 of these participants received at least one dose of study drug.

Reporting Groups
  Description
Placebo Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Exenatide BID Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
Albiglutide 4 mg Weekly Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 15 mg Weekly Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 30 mg Weekly Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 15 mg Bi-weekly Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 30 mg Bi-weekly Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 50 mg Bi-weekly Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 50 mg Every 4 Weeks Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 100 mg Every 4 Weeks Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.

Participant Flow:   Overall Study
    Placebo     Exenatide BID     Albiglutide 4 mg Weekly     Albiglutide 15 mg Weekly     Albiglutide 30 mg Weekly     Albiglutide 15 mg Bi-weekly     Albiglutide 30 mg Bi-weekly     Albiglutide 50 mg Bi-weekly     Albiglutide 50 mg Every 4 Weeks     Albiglutide 100 mg Every 4 Weeks  
STARTED     52     35     36     35     31     34     33     35     35     35  
Safety Population     51 [1]   35 [1]   35 [1]   35 [1]   31 [1]   33 [1]   32 [1]   35 [1]   35 [1]   34 [1]
COMPLETED     40     29     19     24     21     19     25     20     30     20  
NOT COMPLETED     12     6     17     11     10     15     8     15     5     15  
Adverse Event                 6                 1                 5                 6                 5                 5                 5                 10                 2                 9  
Lost to Follow-up                 0                 0                 2                 3                 1                 3                 0                 1                 1                 1  
Protocol Violation                 1                 3                 1                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 1                 1                 5                 0                 2                 1                 0                 2                 1                 3  
Lack of Efficacy                 1                 0                 1                 1                 0                 0                 0                 1                 0                 0  
Non-Compliance                 1                 0                 1                 0                 1                 1                 1                 1                 0                 1  
Treatment Eligibility Criteria Not Met                 1                 1                 0                 0                 0                 4                 0                 0                 0                 0  
Physician Prescribed Antidiabetic Drug                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Different Monotherapy Diabetic Drug                 0                 0                 1                 0                 0                 0                 0                 0                 1                 0  
Wrong Monotherapy Administered                 0                 0                 1                 0                 0                 0                 1                 0                 0                 0  
Violation of Exclusion Criteria                 0                 0                 0                 1                 0                 0                 1                 0                 0                 0  
Family Emergency; Had to Go to England                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0  
Withdrew Consent                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0  
Moved Out of State                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1  
[1] These participants received at least one dose of study drug.



  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 placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Exenatide BID Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
Albiglutide 4 mg Weekly Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 15 mg Weekly Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 30 mg Weekly Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 15 mg Bi-weekly Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 30 mg Bi-weekly Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 50 mg Bi-weekly Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 50 mg Every 4 Weeks Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Albiglutide 100 mg Every 4 Weeks Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Total Total of all reporting groups

Baseline Measures
    Placebo     Exenatide BID     Albiglutide 4 mg Weekly     Albiglutide 15 mg Weekly     Albiglutide 30 mg Weekly     Albiglutide 15 mg Bi-weekly     Albiglutide 30 mg Bi-weekly     Albiglutide 50 mg Bi-weekly     Albiglutide 50 mg Every 4 Weeks     Albiglutide 100 mg Every 4 Weeks     Total  
Number of Participants  
[units: participants]
  51     35     35     35     31     33     32     35     35     34     356  
Age [1]
[units: Years]
Mean ± Standard Deviation
  54.0  ± 10.62     53.7  ± 9.38     50.4  ± 10.25     55.5  ± 10.48     54.2  ± 9.66     52.5  ± 9.55     55.5  ± 9.87     51.1  ± 10.25     54.1  ± 11.30     54.4  ± 9.89     53.5  ± 10.17  
Gender [1]
[units: Participants]
                     
Female     23     19     20     17     23     19     16     16     18     15     186  
Male     28     16     15     18     8     14     16     19     17     19     170  
Race/Ethnicity, Customized [1]
[units: Participants]
                     
African American/African Heritage     8     10     7     4     3     3     5     4     6     5     55  
American Indian or Alaskan Native     0     0     0     0     1     1     1     1     1     0     5  
Asian - Central/South Asian Heritage     0     1     0     1     0     0     4     1     1     1     9  
Asian - East Asian Heritage     2     0     1     0     1     1     1     1     1     0     8  
Asian - Japanese Heritage     0     1     0     0     0     0     0     0     0     0     1  
Asian - South East Asian Heritage     0     0     1     0     0     1     0     2     0     1     5  
Native Hawaiian or Other Pacific Islander     1     1     1     0     0     0     1     0     0     1     5  
White- Arabic/North African Heritage     4     2     2     4     2     0     0     0     3     0     17  
White - White/Caucasian/European Heritage     29     20     18     19     20     21     14     19     18     20     198  
Hispanic     3     0     4     7     2     3     5     5     4     4     37  
Hispanic, Puerto Rican     0     0     0     0     0     0     0     0     1     0     1  
Mestizo     0     0     1     0     0     1     0     1     0     0     3  
Mexican     3     0     0     0     1     2     1     1     0     0     8  
Mulatto     1     0     0     0     1     0     0     0     0     1     3  
Puerto Rican     0     0     0     0     0     0     0     0     0     1     1  
[1] Baseline data are reported for participants in the Safety Population, comprised of all randomly assigned participants who received at least one dose of study drug.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16   [ Time Frame: Baseline and Week 16 ]

2.  Secondary:   Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16   [ Time Frame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16 ]

3.  Secondary:   Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16   [ Time Frame: Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16 ]

4.  Secondary:   Change From Baseline in Waist Circumference at Week 16   [ Time Frame: Baseline and Week 16 ]

5.  Secondary:   Change From Baseline in Body Weight at Week 16   [ Time Frame: Baseline and Week 16 ]

6.  Secondary:   Percent Change From Baseline in Body Weight at Week 16   [ Time Frame: Baseline and Week 16 ]

7.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16   [ Time Frame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16 ]

8.  Secondary:   Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16   [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ]

9.  Secondary:   Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16   [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ]

10.  Secondary:   Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16   [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ]

11.  Secondary:   Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16   [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ]

12.  Secondary:   Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16   [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ]

13.  Secondary:   Change From Baseline in Functional Living Index – Emesis (FLIE) Scores at Week 16   [ Time Frame: Baseline and Week 16 ]

14.  Secondary:   Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16   [ Time Frame: Week 16 ]

15.  Secondary:   Mean Clearance of Albiglutide   [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ]

16.  Secondary:   Mean Volume of Distribution of Albiglutide   [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ]

17.  Secondary:   Mean Absorption Rate of Albiglutide   [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ]

18.  Secondary:   Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG   [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ]


  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


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00518115     History of Changes
Other Study ID Numbers: GLP110125
Study First Received: August 17, 2007
Results First Received: May 1, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration