Exeantide in Type 2 Diabetes on Insulin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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exenatide 5 mcg

Group Type EXPERIMENTAL

exenatide 5 mcg

Intervention Type DRUG

exenatide 5 mcg

exenatide 10 mcg

Group Type EXPERIMENTAL

exenatide 10 mcg

Intervention Type DRUG

exenatide 10 mcg

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

saline sq

Interventions

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exenatide 5 mcg

Intervention Type DRUG

exenatide 10 mcg

Intervention Type DRUG

placebo

saline sq

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No