Exeantide in Type 2 Diabetes on Insulin

Study Overview
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: exenatide 5 mcg
* Drug: exenatide 10 mcg
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exenatide 5 mcg<br>exenatide 5 mcg | Drug: exenatide 5 mcg<br>* exenatide 5 mcg<br>|
| Experimental: exenatide 10 mcg<br>exenatide 10 mcg | Drug: exenatide 10 mcg<br>* exenatide 10 mcg<br>|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* saline sq<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Insulin | To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients. | after 24 hours fast at baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients | value at 12 weeks minus value at baseline | 
| HbA1c | To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients. | value at 12 weeks minus value at baseline | 
| Intranuclear NFκB Binding Activity | Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group | measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, obesity