Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00097500
First received: November 24, 2004
Last updated: October 31, 2013
Last verified: October 2013
Results First Received: December 24, 2010  
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 Mellitus
Interventions: Drug: exenatide
Drug: Insulin glargine
Drug: Metformin

  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
No text entered.

Reporting Groups
  Description
Exenatide Arm 5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
Insulin Glargine Arm Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.

Participant Flow for 2 periods

Period 1:   On-drug Period (Week 0 to Week 52)
    Exenatide Arm     Insulin Glargine Arm  
STARTED     36     33  
COMPLETED     30 [1]   30 [1]
NOT COMPLETED     6     3  
Withdrawal of consent                 1                 1  
Adverse Event                 5                 0  
Physician Decision                 0                 1  
Lost to Follow-up                 0                 1  
[1] Subjects experiencing loss of glucose control after Week 52 are considered to have completed study.

Period 2:   Off-drug Period (Week 52 to Week 64)
    Exenatide Arm     Insulin Glargine Arm  
STARTED     30 [1]   30 [2]
COMPLETED     25     26  
NOT COMPLETED     5     4  
Withdrawal of consent                 2                 1  
Physician Decision                 0                 1  
Loss of glucose control                 3                 2  
[1] Exenatide is discontinued, metformin is continued
[2] Insulin Glargine is discontinued, metformin is continued



  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
Exenatide Arm 5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
Insulin Glargine Arm Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
Total Total of all reporting groups

Baseline Measures
    Exenatide Arm     Insulin Glargine Arm     Total  
Number of Participants  
[units: participants]
  36     33     69  
Age  
[units: years]
Mean ± Standard Deviation
  58.4  ± 8.4     58.3  ± 7.3     58.4  ± 7.8  
Gender  
[units: participants]
     
Female     13     11     24  
Male     23     22     45  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  30.87  ± 4.15     30.13  ± 3.49     30.52  ± 3.84  
Body weight  
[units: kg]
Mean ± Standard Deviation
  90.56  ± 12.66     92.39  ± 13.56     91.44  ± 13.03  
Glycosylated hemoglobin (HbA1c)  
[units: percentage]
Mean ± Standard Deviation
  7.58  ± 0.89     7.41  ± 0.81     7.50  ± 0.85  
Duration of diabetes  
[units: years]
Mean ± Standard Deviation
  5.72  ± 4.70     3.97  ± 3.62     4.88  ± 4.28  



  Outcome Measures
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1.  Primary:   Beta-cell Function After 52 Weeks of Therapy   [ Time Frame: Baseline (week -2) and 52 weeks ]

2.  Secondary:   Beta-cell Function 4 Weeks After Cessation of Therapy   [ Time Frame: Baseline (week -2) and 56 weeks ]

3.  Secondary:   Change in First Phase C-peptide Release   [ Time Frame: baseline (week -2), 52 weeks, and 56 weeks ]

4.  Secondary:   Change in Second Phase C-peptide Release   [ Time Frame: baseline (-2 weeks), 52 weeks, and 56 weeks ]

5.  Secondary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Week 0 and week 52 ]

6.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: 0 weeks and 52 weeks ]

7.  Secondary:   Seven Point Self Monitored Blood Glucose (SMBG) Measurements   [ Time Frame: 0 weeks and 52 weeks ]

8.  Secondary:   Change in Body Weight   [ Time Frame: 0 weeks and 52 weeks ]

9.  Secondary:   M-value at Baseline, Week 52 and Week 56   [ Time Frame: baseline (week -2), 52 weeks, and 56 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00097500     History of Changes
Other Study ID Numbers: 2993-114
Study First Received: November 24, 2004
Results First Received: December 24, 2010
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Sweden: Medical Products Agency