Exeantide in Type 2 Diabetes on Insulin

September 8, 2022 updated by: Paresh Dandona, University at Buffalo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14209
        • Millard Fillmore Gates Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
saline sq
Experimental: exenatide 5 mcg
Drug: exenatide 5 mcg
exenatide 5 mcg
Experimental: exenatide 10 mcg
Drug: exenatide 10 mcg
exenatide 10 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Insulin
Time Frame: 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.
after 24 hours fast at baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 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
value at 12 weeks minus value at baseline
HbA1c
Time Frame: 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.
value at 12 weeks minus value at baseline
Intranuclear NFκB Binding Activity
Time Frame: 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
measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Collaborators

Amylin Pharmaceuticals, LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (Estimate)

July 1, 2010

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1930

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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