Exeantide in Type 2 Diabetes on Insulin

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.

The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaleida Health
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Exenatide; Insulin

Criteria

Inclusion Criteria:

• Males or females 20-75 years of age inclusive.

• Type 2 diabetes

• On insulin therapy

• HbA1c ≥7.5% and ≤ 9%

• BMI ≥ 30 kg/m2

• Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.

Exclusion Criteria:

• Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks

• Pregnancy

• Hepatic disease (abnormal LFT's)

• Use of DPP4 inhibitors.

• Renal impairment (serum creatinine > 1.5)

• Participation in any other concurrent clinical trial

• Any other life-threatening, non-cardiac disease

• Uncontrolled hypertension (BP > 160/100 mm of Hg)

• Congestive Heart Failure.

• Use of an investigational agent or therapeutic regimen within 30 days of study