Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00806520
• Lead Sponsor: HealthPartners Institute

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 control prior to treatment and during treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

University of North Carolina Diabetes Care Center; 🇺🇸 Durham, North Carolina, United States

Rockwood Clinic; 🇺🇸 Spokane, Washington, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

Palm Medical Group; 🇺🇸 Las Vegas, Nevada, United States

International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States