Exeantide in Type 2 Diabetes on Insulin

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: exenatide 5 mcg; Drug: exenatide 10 mcg; Drug: placebo

• Registration Number: NCT01154933
• Lead Sponsor: University at Buffalo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2022-03-08
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Results First Posted: 2022-10-06
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exenatide 5 mcg	exenatide 5 mcg	exenatide 5 mcg
exenatide 10 mcg	exenatide 10 mcg	exenatide 10 mcg
placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Fasting Insulin	after 24 hours fast at baseline and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Weight	value at 12 weeks minus value at baseline	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
HbA1c	value at 12 weeks minus value at baseline	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.
Intranuclear NFκB Binding Activity	measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline	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

Trial Locations

Locations (1)

Millard Fillmore Gates Hospital; 🇺🇸 Buffalo, New York, United States