Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide

HealthPartners Institute

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00803920

03404-06-C

Details and patient eligibility

About

The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide LAR will help determine the characteristics of glucose control during treatment.

Enrollment: 8 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participant in Amylin Protocol 2993LAR-105
• at least 16 years of age
• type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
• A1c 7.1 - 11
• fasting glucose less than 280 at screening
• BMI 25 - 45
• stable body weight 6 months prior to screening
• not pregnant and willing to practice birth control
• physical exam & ECG not clinically significant
• lab values judged not to be clinically significant
• able to understand & sign consent form

Exclusion criteria

• clinically significant medical condition as judged by investigator
• drug or alcohol abuse
• previous use of exenatide or any GLP-1 analog
• has used any investigational drug in the past 30 days prior to screening
• is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
• has donated blood within 60 days of screening, or is planning to donate during the study
• has had major surgery or blood transfusion within 2 months of screening
• has had a surgical procedure that may impact gastric emptying
• has any allergies or hypersensitivity to any component of study treatment
• is an immediate family member of personnel affiliated with the study at the investigative site
• is employed by Amylin, Lilly or Alkermes

Trial design

8 participants in 2 patient groups

Exenatide

Exenatide LAR