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Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00577824
First received: December 18, 2007
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
Results First Received: November 23, 2009  
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
Interventions: Drug: exenatide
Drug: placebo

  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
No text entered.

Reporting Groups
  Description
5mcg Exenatide BID exenatide SC 5mcg, twice daily
10mcg Exenatide BID exenatide SC 10mcg, twice daily
Placebo BID placebo SC, twice daily

Participant Flow:   Overall Study
    5mcg Exenatide BID     10mcg Exenatide BID     Placebo BID  
STARTED     72 [1]   73     36  
Full Analysis Set     72 [2]   72     35  
COMPLETED     65     53     34  
NOT COMPLETED     7     20     2  
Adverse Event                 6                 18                 1  
Patient decision                 0                 1                 1  
Protocol Violation                 1                 1                 0  
[1] Started=Randomized
[2] Full Analysis Set=subject received at least one dose of study medication (active or placebo)



  Baseline Characteristics
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Reporting Groups
  Description
5mcg Exenatide BID exenatide SC 5mcg, twice daily
10mcg Exenatide BID exenatide SC 10mcg, twice daily
Placebo BID placebo SC, twice daily
Total Total of all reporting groups

Baseline Measures
    5mcg Exenatide BID     10mcg Exenatide BID     Placebo BID     Total  
Number of Participants  
[units: participants]
 		  72     72     35     179  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     53     46     27     126  
>=65 years     19     26     8     53  
Age  
[units: years]
Mean ± Standard Deviation 		  58.5  ± 9.33     59.4  ± 9.75     56.3  ± 11.41     58.4  ± 9.94  
Gender  
[units: participants]
 		       
Female     23     23     11     57  
Male     49     49     24     122  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: 24 weeks ]
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2.  Secondary:   Percentage of Patients Achieving HbA1c < 7.0%   [ Time Frame: 24 weeks ]
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3.  Secondary:   Percentage of Patients Achieving HbA1c < 6.5%   [ Time Frame: 24 weeks ]
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4.  Secondary:   Change in Fasting Blood Glucose   [ Time Frame: 24 weeks ]
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5.  Secondary:   Change in Body Weight   [ Time Frame: 24 weeks ]
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6.  Secondary:   Change in Total Cholesterol   [ Time Frame: 24 weeks ]
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7.  Secondary:   Change in Low Density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: 24 weeks ]
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8.  Secondary:   Change in High Density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: 24 weeks ]
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9.  Secondary:   Change in Triglycerides   [ Time Frame: 24 weeks ]
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10.  Secondary:   Change in Waist Size   [ Time Frame: 24 weeks ]
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11.  Secondary:   Change in Waist-to-hip Ratio   [ Time Frame: 24 weeks ]
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12.  Secondary:   7 Point Self-monitored Blood Glucose (SMBG) Profiles   [ Time Frame: 24 weeks ]
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13.  Secondary:   Change in Homeostatis Model Assessment - Beta Cell Function (HOMA-B)   [ Time Frame: 24 weeks ]
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14.  Secondary:   Change in Homeostatis Model Assessment - Insulin Resistance (HOMA-R)   [ Time Frame: 24 weeks ]
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15.  Secondary:   Change in Serum Insulin   [ Time Frame: 24 weeks ]
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16.  Secondary:   Change in C-peptide   [ Time Frame: 24 weeks ]
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17.  Secondary:   Change in 1,5-anhydroglucitol   [ Time Frame: 24 weeks ]
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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
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
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: NCT00577824     History of Changes
Other Study ID Numbers: H8O-JE-GWBB
Study First Received: December 18, 2007
Results First Received: November 23, 2009
Last Updated: February 11, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency