Exeantide in Type 2 Diabetes on Insulin

University at Buffalo

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: exenatide 10 mcg; Drug: placebo; Drug: exenatide 5 mcg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01154933

1930

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 3 patient groups, including a placebo group

exenatide 5 mcg

Experimental group

Description:

exenatide 5 mcg

Treatment:

Drug: exenatide 5 mcg

exenatide 10 mcg

Experimental group

Description:

exenatide 10 mcg

Treatment:

Drug: exenatide 10 mcg

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo