Exeantide in Type 2 Diabetes on Insulin

University at Buffalo24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

exenatide 5 mcgDRUG

exenatide 5 mcg

exenatide 10 mcgDRUG

exenatide 10 mcg

placeboDRUG

saline sq

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

Millard Fillmore Gates Hospital

Buffalo, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: after 24 hours fast at baseline and 12 weeks

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline

Data from ClinicalTrials.gov

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