Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control
NCT ID: NCT00806520
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2008-04-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Amylin Pharmaceuticals, LLC.
INDUSTRY
HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Richard M. Bergenstal, MD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Roger S. Mazze, PhD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Robert M. Cuddihy, MD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Elinor (Ellie) S. Strock, APRN, BS,CDE
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Locations
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Joslin Diabetes Center
Boston, Massachusetts, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Palm Medical Group
Las Vegas, Nevada, United States
University of North Carolina Diabetes Care Center
Durham, North Carolina, United States
Rockwood Clinic
Spokane, Washington, United States
Countries
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Other Identifiers
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03671-08-C
Identifier Type: -
Identifier Source: org_study_id