Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00641056
First received: March 17, 2008
Last updated: September 16, 2013
Last verified: September 2013
Results First Received: February 14, 2012  
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 Once Weekly
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
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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
Exenatide Once Weekly Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
Insulin Glargine Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.

Participant Flow:   Overall Study
    Exenatide Once Weekly     Insulin Glargine  
STARTED     233     234  
Intent to Treat (ITT)     233     223  
COMPLETED     204     209  
NOT COMPLETED     29     25  
Adverse Event                 12                 2  
Lost to Follow-up                 2                 1  
Physician Decision                 3                 1  
Protocol Violation                 2                 0  
Entry Criteria Not Met                 3                 0  
Subject Decision                 6                 19  
Sponsor Decision                 1                 2  



  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.
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Reporting Groups
  Description
Exenatide Once Weekly Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
Insulin Glargine Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly     Insulin Glargine     Total  
Number of Participants  
[units: participants]
  233     223     456  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     184     167     351  
>=65 years     49     56     105  
Age  
[units: years]
Mean ± Standard Deviation
  57.6  ± 9.72     58.3  ± 9.08     57.9  ± 9.41  
Gender  
[units: participants]
     
Female     113     100     213  
Male     120     123     243  
Glycosylated hemoglobin (HbA1c)  
[units: percentage of total hemoglobin]
Mean ± Standard Deviation
  8.32  ± 1.094     8.29  ± 1.020     8.31  ± 1.057  
Weight  
[units: kg]
Mean ± Standard Deviation
  91.22  ± 18.582     90.56  ± 16.348     90.90  ± 17.509  
Background Oral Antidiabetic Agent (OAD)  
[units: participants]
     
Metformin (Met)     164     157     321  
Met+Sulfonylurea (SU)     69     66     135  



  Outcome Measures
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1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

2.  Secondary:   Percentage of Patients Achieving HbA1c <=7.0% at Week 26   [ Time Frame: Baseline, Week 26 ]

3.  Secondary:   Percentage of Patients Achieving HbA1c <=6.5% at Week 26   [ Time Frame: Baseline, Week 26 ]

4.  Secondary:   Change in Fasting Serum Glucose (FSG) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

5.  Secondary:   Change in Body Weight (BW) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

6.  Secondary:   Change in Total Cholesterol From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

7.  Secondary:   Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

8.  Secondary:   Ratio of Triglycerides at Week 26 to Baseline   [ Time Frame: Baseline, Week 26 ]

9.  Secondary:   Change in Blood Pressure From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

10.  Secondary:   Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes   [ Time Frame: Baseline to 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
phone: 1-800-LILLYRX
e-mail: clinicaltrials@amylin.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00641056     History of Changes
Other Study ID Numbers: H8O-MC-GWBR (DURATION - 3)
Study First Received: March 17, 2008
Results First Received: February 14, 2012
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration