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Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00765817
First received: October 1, 2008
Last updated: May 1, 2013
Last verified: February 2013
History of Changes
Results First Received: January 4, 2011  
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: placebo
Drug: exenatide

  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
Two subjects who started the study, subsequently withdrew prior to receiving study medication and are not part of the full analysis set

Reporting Groups
  Description
Exenatide Arm Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo Arm Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Participant Flow:   Overall Study
    Exenatide Arm     Placebo Arm  
STARTED     138 [1]   123 [1]
COMPLETED     112     101  
NOT COMPLETED     26     22  
Adverse Event                 13                 1  
Death                 0                 1  
Entry criteria not met                 2                 2  
Loss of glucose control                 0                 2  
Lost to Follow-up                 1                 3  
Physician Decision                 2                 1  
Protocol Violation                 1                 1  
Subject decision                 7                 11  
[1] One subject withdrew prior to receiving study medication, not included in analysis set



  Baseline Characteristics
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Reporting Groups
  Description
Exenatide Arm Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo Arm Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Total Total of all reporting groups

Baseline Measures
    Exenatide Arm     Placebo Arm     Total  
Number of Participants  
[units: participants]
 		  137     122     259  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     100     84     184  
>=65 years     37     38     75  
Age  
[units: years]
Mean ± Standard Deviation 		  58.67  ± 8.91     59.40  ± 9.96     59.01  ± 9.41  
Gender  
[units: participants]
 		     
Female     67     44     111  
Male     70     78     148  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: baseline and 30 weeks ]
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2.  Secondary:   Percentage of Patients Achieving HbA1c <=7%   [ Time Frame: baseline and 30 weeks ]
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3.  Secondary:   Percentage of Patients Achieving HbA1c <=6.5%   [ Time Frame: baseline and 30 weeks ]
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4.  Secondary:   Change in Fasting Serum Glucose   [ Time Frame: baseline and 30 weeks ]
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5.  Secondary:   Change in 7-point Self-monitored Blood Glucose (SMBG) Profile   [ Time Frame: baseline and 30 weeks ]
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6.  Secondary:   Change in Total Cholesterol   [ Time Frame: baseline and 30 weeks ]
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7.  Secondary:   Change in Low Density Lipoprotein (LDL) Cholesterol   [ Time Frame: baseline and 30 weeks ]
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8.  Secondary:   Change in High Density Lipoprotein (HDL) Cholesterol   [ Time Frame: baseline and 30 weeks ]
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9.  Secondary:   Change in Triglycerides   [ Time Frame: baseline and 30 weeks ]
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10.  Secondary:   Change in Body Weight   [ Time Frame: baseline and 30 weeks ]
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11.  Secondary:   Change in Waist Circumference   [ Time Frame: baseline and 30 weeks ]
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12.  Secondary:   Change in Daily Insulin Dose   [ Time Frame: baseline and 30 weeks ]
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13.  Secondary:   Change in Daily Insulin Dose (on a Per Body Weight Basis)   [ Time Frame: baseline and 30 weeks ]
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14.  Secondary:   Change in Systolic Blood Pressure (SBP)   [ Time Frame: baseline and 30 weeks ]
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15.  Secondary:   Change in Diastolic Blood Pressure (DBP)   [ Time Frame: baseline and 30 weeks ]
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16.  Secondary:   Minor Hypoglycemia Rate Per Year   [ Time Frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30 ]
  Show Outcome Measure 16

17.  Secondary:   Percentage of Subjects Experiencing Minor Hypoglycemia   [ Time Frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30 ]
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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: NCT00765817     History of Changes
Other Study ID Numbers: H80-US-GWCO
Study First Received: October 1, 2008
Results First Received: January 4, 2011
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Greece: Ethics Committee
Mexico: Ethics Committee
Israel: Ministry of Health