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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Type 2 Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Glucose Monitoring, Exenatide Once Weekly or, Januvia or, Actos