Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes (DURATION-NEO-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01652716
First received: July 26, 2012
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: August 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Exenatide once weekly suspension
Drug: Exenatide twice daily

  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
Subjects were randomized across two treatment groups (exenatide once weekly and exenatide twice daily) in a ratio of 3:2 with randomization stratified by diabetes management method at screening, screening haemoglobin A1c (HbA1c) stratum and renal function.

Reporting Groups
  Description
Experimental: Exenatide Once Weekly (QWS) Suspension Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
Active Comparator: Exenatide Twice Daily (BID) Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks

Participant Flow:   Overall Study
    Experimental: Exenatide Once Weekly (QWS) Suspension     Active Comparator: Exenatide Twice Daily (BID)  
STARTED     229     148 [1]
Completed 28-week     197     118  
COMPLETED     173 [2]   102 [2]
NOT COMPLETED     56     46  
Loss of glucose control                 1                 0  
Administrative                 0                 2  
Investigator decision                 1                 4  
Lost to Follow-up                 12                 11  
Protocol Violation                 2                 1  
Adverse Event                 7                 10  
Withdrawal by Subject                 33                 18  
[1] Two subjects in the exenatide BID group withdrew from the study before receiving study drug.
[2] * completed study



  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.
Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug

Reporting Groups
  Description
Experimental: Exenatide QWS Suspension Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
Active Comparator: Exenatide BID Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Experimental: Exenatide QWS Suspension     Active Comparator: Exenatide BID     Total  
Number of Participants  
[units: participants]
  229     146     375  
Age  
[units: Years]
Mean (Standard Deviation)
  55.6  (9.98)     56.5  (9.04)     56.0  (9.62)  
Age, Customized  
[units: Participants]
     
<65 years     182     118     300  
>=65 years     47     28     75  
Gender  
[units: Participants]
     
Female     81     54     135  
Male     148     92     240  
Race/Ethnicity, Customized  
[units: Participants]
     
Hispanic or Latino     54     34     88  
Not Hispanic or Latino     174     112     286  
Unknown     1     0     1  
Race/Ethnicity, Customized  
[units: Participants]
     
White     168     110     278  
Black or African American     38     23     61  
Asian     17     8     25  
Other     3     2     5  
American Indian or Alaska Native     2     3     5  
Native Hawaiian or Other Pacific Islander     1     0     1  
Weight  
[units: lbs]
Mean (Standard Deviation)
  214.52  (49.788)     213.19  (40.834)     214.00  (46.445)  
Baseline HbA1c  
[units: Percentage of total hemoglobin]
Mean (Standard Deviation)
  8.47  (1.047)     8.51  (1.004)     8.48  (1.029)  
HbA1c Stratum  
[units: Number of subjects]
     
<9.0%     159     97     256  
>=9.0%     68     49     117  
Not Recorded     2     0     2  
Fasting plasma glucose  
[units: mg/dL]
Mean (Standard Deviation)
  180.92  (44.538)     183.77  (46.904)     182.03  (45.437)  
Duration of diabetes  
[units: Years]
Mean (Standard Deviation)
  8.55  (6.249)     8.47  (5.961)     8.52  (6.132)  



  Outcome Measures
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1.  Primary:   Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28   [ Time Frame: Baseline to Week 28 ]

2.  Secondary:   Percentage of Subjects Achieving HbA1c <7% at Week 28   [ Time Frame: Baseline to Week 28 ]

3.  Secondary:   Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28   [ Time Frame: Baseline to Week 28 ]

4.  Secondary:   Change in Body Weight (kg) From Baseline to Week 28   [ Time Frame: Baseline to Week 28 ]

5.  Secondary:   Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]


  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: ClinicalTrialTransparency@astrazeneca.com
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01652716     History of Changes
Other Study ID Numbers: BCB118
MB001-003 ( Other Identifier: Bristol Myers Squibb )
Study First Received: July 26, 2012
Results First Received: August 4, 2015
Last Updated: December 22, 2015
Health Authority: United States: Food and Drug Administration