Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2006 |
| End Date: | February 2008 |
CGM Substudy, Addendum 2, of the Following Exenatide LAR Protocol 2993LAR-105: A Randomized, Open-Label, Multicenter, Comparator Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications)
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 help determine the characteristics of glucose control during treatment.
CGM measurements gathered before starting and during treatment with exenatide IR and/or
exenatide LAR will help determine the characteristics of glucose control during treatment.
Inclusion Criteria:
- 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 Criteria:
- 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
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