Status:
COMPLETED
Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
Obtain Continuous Glucose Monitoring (CGM) data from individuals taking exenatide LAR, sitagliptin, or pioglitazone. The CGM measurements collected will help determine the characteristics of glucose c...
Eligibility Criteria
Inclusion
- 18 years or older
- type 2 diabetes
- A1c 7.1 - 11
- BMI 25 - 45
- stable weight for 3 months before screening
- fasting glucose \< 280 at screening
- stable dose of metformin for at least 2 months before screening
- not being treated with or on a stable dose of hormone replacement therapy, oral contraceptives, anti-hypertensive agents, lipid lowering agents, thyroid replacement therapy, anti-depressants, drugs known to affect body weight
- male or female, non-lactating, non-pregnant and willing to use birth control
- lab values that are not clinically significant at screening
- physical exam and ECG that are not clinically significant at screening
- able to read, understand, and sign consent form
Exclusion
- liver disease
- renal disease
- cardiovascular disease
- gastroparesis
- cancer within 5 years of screening
- macular edema
- chronic infections
- drug or alcohol abuse
- fasting triglycerides \> or = 600 at screening
- previous exposure to exenatide LAR
- has donated blood within 60 days of screening or is planning to donate during the study
- has had a major surgery or blood transfusion within 2 months before screening
- is currently being treated or is expecting to be treated with Byetta, Januvia, SU, TZD, GLP-1 analog, alpha-glucosidase inhibitor, meglitinide, nateglinide, symlin, insulin, systemic corticosteroids, lopid or rifampin
- has received an investigational drug within 1 month before screening
- has allergies or hypersensitivity to any component of the study drug
- has previously had an adverse event related to TZD or Januvia
- is an immediate family member of the study sight or directly affiliated
- is employed by Amylin, Lilly or Alkermes
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00806520
Start Date
April 1 2008
End Date
August 1 2011
Last Update
December 2 2015
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
2
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
3
Palm Medical Group
Las Vegas, Nevada, United States, 89148
4
University of North Carolina Diabetes Care Center
Durham, North Carolina, United States, 27713