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

NCT00806520 | Completed

• 1 other identifier: 03671-08-C
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 5

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.

Conditions

Type 2 Diabetes

Keywords

Continuous Glucose Monitoring; Exenatide Once Weekly or; Januvia or; Actos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in the Amylin BCB106 Protocol Main Study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (5)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Palm Medical Group

Las Vegas, Nevada, 89148, United States

Location

University of North Carolina Diabetes Care Center

Durham, North Carolina, 27713, United States

Location

Rockwood Clinic

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Richard M. Bergenstal, MD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

• Roger S. Mazze, PhD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

• Robert M. Cuddihy, MD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

• Elinor (Ellie) S. Strock, APRN, BS,CDE

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 2, 2015

Record last verified: 2011-08

Locations

US (5)