The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring endothelial dysfunction, subclinical inflammation, flow mediated brachial artery dilation, pulse wave analysis, glucagon like polypeptide mimetics, type 2 diabetes mellitus
Eligibility Criteria
Inclusion Criteria: age 18-75 Type 2 Diabetes (diagnosed at least 3 months prior to study) HbA1c: above 7.0 and less than or equal to 10.0 At least one HbA1c over preceding 3-6 months, and HbA1c at screening, with less than 1% difference between lowest and highest values Stable doses of antidiabetic medications (SU and/or Metformin) for 3 months reproductive age females must have negative urine HCG at screening, and be using appropriate contraception during the study or be surgically sterile postmenopausal woman stable weight for 3 months prior to study (+/- 2kg) willingness to participate in the study Exclusion Criteria: Type 1 diabetes Type 2 diabetes less than 3 months in duration HbA1c less than 7.0 or greater than 10 age less than 18 or greater than 75 pregnant or planning to become pregnant during study period current insulin therapy or insulin within 6 months prior to study current use of Thiazolidinedione or within 6 months prior to study current use of Nateglinide or Repaglinide current use of an Alpha-glucosidase Inhibitor current weight loss program active smoker, or quit smoking within preceding 6 months creatinine greater than 2.0 mg/dL total cholesterol greater than 300 mg/dL triglycerides greater than 600 mg/dL blood pressure greater than 160/105 mmHg ALT/AST greater than twice the upper limit of normal any other medical condition that may interfere with trial participation or trial results if on Statin: Statin therapy for less than 3 months or dose change within preceding 3 months if on ACE Inhibitor: ACE Inhibitor therapy for less than 3 months or dose change within preceding 3 months current use of any medication that is known to alter gastric motility
Sites / Locations
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Glargine insulin
Exenatide
Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.
Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.