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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:
ClinicalTrials.gov Identifier:
NCT00676338
First Posted: May 13, 2008
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
Results First Submitted: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
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 (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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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 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 
Overall Participants Analyzed 
[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 ]

2.  Primary:   Percentage of Patients Achieving HbA1c <=7% at Week 26   [ Time Frame: Baseline, Week 26 ]

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

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

5.  Secondary:   Change in Fasting Total Cholesterol (TC) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

6.  Secondary:   Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

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

8.  Secondary:   Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]

9.  Secondary:   Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]

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

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


Results Point of Contact:  
Name/Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00676338     History of Changes
Other Study ID Numbers: H8O-MC-GWCH (DURATION - 4)
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: February 14, 2012
Results First Posted: November 26, 2012
Last Update Posted: April 9, 2015