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A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637273
First received: March 6, 2008
Last updated: June 4, 2014
Last verified: June 2014
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide once weekly
Drug: sitagliptin
Drug: pioglitazone
Drug: placebo tablet
Drug: placebo once weekly

  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
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Reporting Groups
  Description
Exenatide Once Weekly Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
Sitagliptin Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
Pioglitazone Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly

Participant Flow:   Overall Study
    Exenatide Once Weekly     Sitagliptin     Pioglitazone  
STARTED     170     172     172  
Intent to Treat (ITT)     160     166     165  
COMPLETED     127     144     131  
NOT COMPLETED     43     28     41  
Adverse Event                 11                 5                 7  
Lost to Follow-up                 8                 9                 13  
Protocol Violation                 2                 4                 1  
Withdrawal of Consent                 18                 6                 18  
Investigator Decision                 1                 3                 1  
Administrative                 2                 0                 0  
Loss of Glucose Control                 1                 1                 1  



  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 Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
Sitagliptin Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
Pioglitazone Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly     Sitagliptin     Pioglitazone     Total  
Number of Participants  
[units: participants]
  160     166     165     491  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     140     149     143     432  
>=65 years     20     17     22     59  
Age  
[units: years]
Mean ± Standard Deviation
  52.4  ± 10.41     52.2  ± 10.54     53.0  ± 9.92     52.5  ± 10.28  
Gender  
[units: participants]
       
Female     71     80     86     237  
Male     89     86     79     254  
Glycosylated hemoglobin (HbA1c)  
[units: percentage of total hemoglobin]
Mean ± Standard Deviation
  8.6  ± 1.20     8.5  ± 1.17     8.5  ± 1.08     8.5  ± 1.15  
Weight  
[units: kg]
Mean ± Standard Deviation
  89.1  ± 19.55     87.0  ± 20.25     87.9  ± 20.49     88.0  ± 20.08  



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

2.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <7% at Week 26   [ Time Frame: Week 26 ]

3.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26   [ Time Frame: Week 26 ]

4.  Secondary:   Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26   [ Time Frame: Week 26 ]

5.  Secondary:   Change in Body Weight From Baseline to Week 26   [ Time Frame: Day 1, Week 26 ]

6.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Week 26   [ Time Frame: Day 1, Week 26 ]

7.  Secondary:   Change in Systolic Blood Pressure From Baseline to Week 26   [ Time Frame: Day 1, Week 26 ]

8.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 26   [ Time Frame: Day 1, Week 26 ]

9.  Secondary:   Change in Fasting Total Cholesterol From Baseline to Week 26   [ Time Frame: Day 1, Week 26 ]

10.  Secondary:   Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26   [ Time Frame: Day 1, Week 26 ]

11.  Secondary:   Ratio of Fasting Triglycerides at Week 26 to Baseline   [ Time Frame: Day 1, Week 26 ]

12.  Secondary:   Assessment on Event Rate of Treatment-emergent Hypoglycemic Events   [ Time Frame: Day 1 to Week 26 ]


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


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 AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00637273     History of Changes
Other Study ID Numbers: BCB106 (DURATION - 2)
Study First Received: March 6, 2008
Results First Received: February 14, 2012
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration