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Exeantide in Type 2 Diabetes on Insulin

Information source: Kaleida Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: exenatide 5 mcg (Drug); exenatide 10 mcg (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Kaleida Health

Official(s) and/or principal investigator(s):
Paresh Dandona, MBBS, Principal Investigator, Affiliation: SUNY at Buffalo


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.

Clinical Details

Official title: The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: insulin dose

Secondary outcome:





Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Millard Fillmore Gates Hospital, Buffalo, New York 14209, United States
Additional Information

Starting date: April 2008
Last updated: December 14, 2012

Page last updated: August 23, 2015

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