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Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00676338
First received: May 9, 2008
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
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: metformin
Drug: sitagliptin
Drug: pioglitazone

  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 Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
Metformin Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
Pioglitazone Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
Sitagliptin Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection

Participant Flow:   Overall Study
    Exenatide Once Weekly     Metformin     Pioglitazone     Sitagliptin  
STARTED     248     246     163     163  
COMPLETED     210     213     133     140  
NOT COMPLETED     38     33     30     23  
Adverse Event                 6                 6                 5                 1  
Lost to Follow-up                 4                 1                 3                 4  
Physician Decision                 3                 3                 2                 3  
Protocol Violation                 5                 9                 2                 5  
Withdrawal by Subject                 17                 9                 12                 6  
Entry Criteria Not Met                 0                 2                 1                 1  
Lack of Efficacy-Loss of Glucose Control                 3                 3                 5                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Exenatide Once Weekly Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
Metformin Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
Pioglitazone Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
Sitagliptin Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly     Metformin     Pioglitazone     Sitagliptin     Total  
Number of Participants  
[units: participants]
 		  248     246     163     163     820  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     217     215     135     144     711  
>=65 years     31     31     28     19     109  
Age  
[units: years]
Mean ± Standard Deviation 		  53.7  ± 10.91     53.7  ± 11.08     55.3  ± 10.96     52.3  ± 11.05     53.7  ± 11.02  
Gender  
[units: participants]
 		         
Female     109     92     66     69     336  
Male     139     154     97     94     484  
Glycosylated hemoglobin (HbA1c)  
[units: percentage of total hemoglobin]
Mean ± Standard Deviation 		  8.5  ± 1.19     8.6  ± 1.20     8.5  ± 1.24     8.5  ± 1.25     8.5  ± 1.22  
Weight  
[units: kg]
Mean ± Standard Deviation 		  87.5  ± 18.88     85.9  ± 19.57     86.1  ± 17.77     88.7  ± 18.65     87.0  ± 18.83  



  Outcome Measures
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1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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2.  Primary:   Percentage of Patients Achieving HbA1c <=7% at Week 26   [ Time Frame: Baseline, Week 26 ]
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3.  Secondary:   Change in Fasting Serum Glucose (FSG) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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4.  Secondary:   Change in Body Weight From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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5.  Secondary:   Change in Fasting Total Cholesterol (TC) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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6.  Secondary:   Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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7.  Secondary:   Ratio of Fasting Triglycerides at Week 26 to Baseline   [ Time Frame: Baseline, Week 26 ]
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8.  Secondary:   Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]
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9.  Secondary:   Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]
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10.  Secondary:   Change in Systolic Blood Pressure From Baseline to Week 26.   [ Time Frame: Baseline, Week 26 ]
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11.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 26.   [ Time Frame: Baseline, Week 26 ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-877-285-4559
e-mail: clinicaltrials@amylin.com


No publications provided by Amylin Pharmaceuticals, LLC.

Publications automatically indexed to this study:


Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00676338     History of Changes
Other Study ID Numbers: H8O-MC-GWCH (DURATION - 4)
Study First Received: May 9, 2008
Results First Received: February 14, 2012
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration