Status:
COMPLETED
Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
16+ years
Brief Summary
The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide LAR will hel...
Eligibility Criteria
Inclusion
- participant in Amylin Protocol 2993LAR-105
- at least 16 years of age
- type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
- A1c 7.1 - 11
- fasting glucose less than 280 at screening
- BMI 25 - 45
- stable body weight 6 months prior to screening
- not pregnant and willing to practice birth control
- physical exam \& ECG not clinically significant
- lab values judged not to be clinically significant
- able to understand \& sign consent form
Exclusion
- clinically significant medical condition as judged by investigator
- drug or alcohol abuse
- previous use of exenatide or any GLP-1 analog
- has used any investigational drug in the past 30 days prior to screening
- is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
- has donated blood within 60 days of screening, or is planning to donate during the study
- has had major surgery or blood transfusion within 2 months of screening
- has had a surgical procedure that may impact gastric emptying
- has any allergies or hypersensitivity to any component of study treatment
- is an immediate family member of personnel affiliated with the study at the investigative site
- is employed by Amylin, Lilly or Alkermes
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00803920
Start Date
December 1 2006
End Date
February 1 2008
Last Update
December 3 2015
Active Locations (1)
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1
International Diabetes Center
Minneapolis, Minnesota, United States, 55416