Exeantide in Type 2 Diabetes on Insulin

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154933
• Other study ID #: 1930
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: November 2011

Study information

• Verified date: September 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• exenatide 5 mcg
exenatide 5 mcg
• exenatide 10 mcg
exenatide 10 mcg
• placebo
saline sq

Locations

Country	Name	City	State
United States	Millard Fillmore Gates Hospital	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Intranuclear NF?B 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