Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00082381
First received: May 6, 2004
Last updated: September 18, 2013
Last verified: September 2013
Results First Received: July 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Exenatide (AC2993)
Drug: Insulin glargine

  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
Two patients were lost to follow-up after receiving study drug, and it is not known if they took at least one dose of the drug. For purposes of data analysis, these patients were classified as untreated.

Reporting Groups
  Description
Exenatide Arm Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
Insulin Glargine Arm Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)

Participant Flow:   Overall Study
    Exenatide Arm     Insulin Glargine Arm  
STARTED     283     268  
Received Treatment (Intent to Treat)     282     267  
COMPLETED     228     242  
NOT COMPLETED     55     26  
Adverse Event                 27                 2  
Lost to Follow-up                 5                 7  
Patient Decision                 8                 4  
Physician Decision                 1                 2  
Protocol Violation                 10                 11  
Loss of Glucose Control                 4                 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.
No text entered.

Reporting Groups
  Description
Exenatide Arm Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
Insulin Glargine Arm Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
Total Total of all reporting groups

Baseline Measures
    Exenatide Arm     Insulin Glargine Arm     Total  
Number of Participants  
[units: participants]
  282     267     549  
Age  
[units: years]
Mean ± Standard Deviation
  59.80  ± 8.82     57.96  ± 9.46     58.91  ± 9.13  
Gender  
[units: participants]
     
Female     127     116     243  
Male     155     151     306  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, week 26 ]

2.  Secondary:   Percentage of Patients Achieving HbA1c <=7%   [ Time Frame: 26 weeks ]

3.  Secondary:   Change in Body Weight   [ Time Frame: Baseline, week 26 ]

4.  Secondary:   Change in Fasting Serum Glucose   [ Time Frame: Baseline, week 26 ]

5.  Secondary:   Change in 7-point Self-monitored Blood Glucose (SMBG) Profile   [ Time Frame: Baseline, week 26 ]

6.  Secondary:   Percentage of Patients With Hypoglycemic Events   [ Time Frame: 26 weeks ]

7.  Secondary:   Change in Rate of Hypoglycemic Events   [ Time Frame: Baseline, week 26 ]


  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: Chief Medical Officer
Organization: Eli Lilly and Company
e-mail: clinicaltrials@amylin.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00082381     History of Changes
Other Study ID Numbers: H8O-MC-GWAA
Study First Received: May 6, 2004
Results First Received: July 16, 2009
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration