A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01104701
First received: April 13, 2010
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: June 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: Type 2 Diabetes
Interventions: Drug: exenatide once weekly
Drug: exenatide once monthly suspension

  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
Study initiated 22-May-2010; completed 27-Dec-2010. Once weekly arm: first dose of exenatide administered at study-site on Day 1; self-administered on a weekly basis over subsequent 20 weeks. Once monthly arm: first dose of exenatide administered at study-site on Day 1;self-administered on monthly basis by participants over next 20 weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
2 mg Exenatide Weekly 2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg Exenatide Monthly 5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg Exenatide Monthly 8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
11 mg Exenatide Monthly 11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.

Participant Flow:   Overall Study
    2 mg Exenatide Weekly     5 mg Exenatide Monthly     8 mg Exenatide Monthly     11 mg Exenatide Monthly  
STARTED     30     30     31     30  
COMPLETED     30     27     29     28  
NOT COMPLETED     0     3     2     2  
Withdrawal by Subject                 0                 1                 2                 1  
Adverse Event                 0                 0                 0                 1  
Physician Decision                 0                 2                 0                 0  



  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.
All participants who were randomized and received at least one dose of study study drug were analyzed in the intent to treat (ITT) population.

Reporting Groups
  Description
2 mg Exenatide Weekly 2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
5 mg Exenatide Monthly 5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg Exenatide Monthly 8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg Exenatide Monthly 11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
Total Total of all reporting groups

Baseline Measures
    2 mg Exenatide Weekly     5 mg Exenatide Monthly     8 mg Exenatide Monthly     11 mg Exenatide Monthly     Total  
Number of Participants  
[units: participants]
  30     30     31     30     121  
Age, Customized  
[units: participants]
         
Less than (<) 65 years of age     28     29     26     27     110  
Greater than, equal to (≥) 65 years of age     2     1     5     3     11  
Gender  
[units: participants]
         
Female     10     13     7     13     43  
Male     20     17     24     17     78  
Race/Ethnicity, Customized  
[units: participants]
         
Asian     0     1     0     2     3  
Black or African American     1     4     2     5     12  
White     28     24     29     23     104  
Other     1     1     0     0     2  
Region of Enrollment  
[units: participants]
         
United States     30     30     31     30     121  
Mean Hemoglobin A1c (HbA1c) [1]
[units: Percent of hemoglobin]
Mean ± Standard Deviation
  8.64  ± 1.19     8.54  ± 1.18     8.54  ± 1.18     8.37  ± 1.34     8.52  ± 1.21  
Category of HbA1c  
[units: participants]
         
HbA1c < 9.0%     20     18     19     21     78  
HbA1c ≥ 9.0%     10     12     12     9     43  
[1] HbA1c is measured as a percent (%) of all hemoglobin.



  Outcome Measures
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1.  Primary:   Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population   [ Time Frame: Baseline (Day 1) to 20 weeks ]

2.  Secondary:   Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population   [ Time Frame: Week 20 ]

3.  Secondary:   Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population   [ Time Frame: Baseline (Day 1) to Week 20 ]

4.  Secondary:   Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population   [ Time Frame: Baseline (Day 1) to Week 20 ]

5.  Secondary:   Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population   [ Time Frame: Day 1 to Week 20 ]

6.  Secondary:   Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population   [ Time Frame: Baseline (Day 1), Week 20 ]

7.  Secondary:   Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population   [ Time Frame: Baseline (Day 1), Week 20 ]

8.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population   [ Time Frame: Day 1 to Study Termination (24 Weeks) or early Termination ]

9.  Secondary:   Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population   [ Time Frame: Day 1 through study termination (Week 24) or early termination. ]

10.  Secondary:   Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population   [ Time Frame: Day 1 to Study Termination (24 weeks) or early termination ]

11.  Secondary:   Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population   [ Time Frame: Day 1 to study termination (24 weeks) or early termination ]

12.  Secondary:   Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population   [ Time Frame: Day 1 to Study Termination (Week24) or early termination ]


  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: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01104701     History of Changes
Other Study ID Numbers: BCB111
Study First Received: April 13, 2010
Results First Received: June 17, 2014
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration