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

Type 2 Diabetes Clinical Trial

Official title:

Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control Addendum to: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release to Those of Sitagliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin (Study BCB106)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806520
• Other study ID #: 03671-08-C
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: November 30, 2015
• Start date: April 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of North Carolina Diabetes Care Center	Durham	North Carolina
United States	Palm Medical Group	Las Vegas	Nevada
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Rockwood Clinic	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States,