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A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00917267
First received: June 8, 2009
Last updated: June 13, 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: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide once weekly
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
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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 Subcutaneous injection of 2 mg exenatide, once a week
Exenatide Twice Daily Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)

Participant Flow:   Overall Study
    Exenatide Once Weekly     Exenatide Twice Daily  
STARTED     346     345  
Intent to Treat (ITT)     340     338  
COMPLETED     307     266  
NOT COMPLETED     39     79  
Adverse Event                 15                 36  
Physician Decision                 2                 4  
Protocol Violation                 9                 18  
Withdrawal by Subject                 5                 12  
Lost to follow up                 0                 2  
Entry Criteria Not Met                 1                 0  
Sponsor Decision                 5                 5  
Lack of Efficacy-Loss of Glucose Control                 2                 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.
No text entered.

Reporting Groups
  Description
Exenatide Once Weekly Subcutaneous injection of 2 mg exenatide, once a week
Exenatide Twice Daily Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly     Exenatide Twice Daily     Total  
Number of Participants  
[units: participants]
  340     338     678  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     275     274     549  
>=65 years     65     64     129  
Age  
[units: years]
Mean ± Standard Deviation
  55.4  ± 10.59     56.2  ± 9.99     55.8  ± 10.30  
Gender  
[units: participants]
     
Female     157     154     311  
Male     183     184     367  
Glycosylated hemoglobin (HbA1c)  
[units: percentage of total hemoglobin]
Mean ± Standard Deviation
  8.7  ± 1.04     8.7  ± 1.03     8.7  ± 1.03  
Weight  
[units: kg]
Mean ± Standard Deviation
  69.6  ± 12.44     70.4  ± 12.09     70.0  ± 12.26  
Background Oral Antidiabetic Agent (OAD)  
[units: participants]
     
Metformin (MET)     62     60     122  
MET+Sulfonylurea (SU)     210     216     426  
MET+SU+Thiazolidinedione (TZD)     6     10     16  
MET+TZD     12     9     21  
SU     30     29     59  
SU+TZD     18     12     30  
TZD     2     2     4  



  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 Targets <=7% at Week 26   [ Time Frame: Baseline, Week 26 ]

3.  Secondary:   Percentage of Patients Achieving HbA1c Targets <=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 (TC) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

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

8.  Secondary:   Ratio of Triglycerides (TG) 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 of Event Rate of Treatment-emergent Hypoglycemic Events   [ Time Frame: Baseline 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 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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-877-285-4559
e-mail: clinicaltrials@amylin.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00917267     History of Changes
Other Study ID Numbers: H8O-MC-GWCK
Study First Received: June 8, 2009
Results First Received: February 14, 2012
Last Updated: June 13, 2014
Health Authority: China: Food and Drug Administration
India: Drugs Controller General of India
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health