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

CGM Substudy, Addendum 2, of the Following Exenatide LAR Protocol 2993LAR-105: A Randomized, Open-Label, Multicenter, Comparator Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications)

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.

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