Status:
COMPLETED
Exeantide in Type 2 Diabetes on Insulin
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief 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 inflam...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01154933
Start Date
April 1 2008
End Date
November 1 2011
Last Update
October 6 2022
Active Locations (1)
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1
Millard Fillmore Gates Hospital
Buffalo, New York, United States, 14209