Exeantide in Type 2 Diabetes on Insulin

This study has been completed.

Sponsor:

Collaborator:

Amylin Pharmaceuticals, LLC.

Information provided by (Responsible Party):

Paresh Dandona, MD, Kaleida Health

ClinicalTrials.gov Identifier:

NCT01154933

First received: June 30, 2010

Last updated: December 14, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2010

Last Updated Date

December 14, 2012

Start Date ^ICMJE

April 2008

Primary Completion Date

November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

insulin dose [ Time Frame: 12 weeks ]

To compare the total insulin dose 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01154933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

weight [ Time Frame: 12 weeks ]
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 [ Time Frame: 12 weeks ]
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.
inflammation [ Time Frame: 12 weeks ]
To investigate the hypothesis that a single dose of exenatide subcutaneously (5 mcg/injection) decreases the intranuclear NFκB binding activity and decreases the transcription of pro-inflammatory genes regulated by NFκB in MNC's of insulin treated type 2 diabetic patients as compared to placebo.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Exeantide in Type 2 Diabetes on Insulin

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

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

Study Arms

Experimental: exenatide 5 mcg
exenatide 5 mcg

Intervention: Drug: exenatide 5 mcg
Experimental: exenatide 10 mcg
exenatide 10 mcg

Intervention: Drug: exenatide 10 mcg
Placebo Comparator: placebo
placebo

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01154933

Other Study ID Numbers ^ICMJE

1930

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Paresh Dandona, MD, Kaleida Health

Study Sponsor ^ICMJE

Kaleida Health

Collaborators ^ICMJE

Amylin Pharmaceuticals, LLC.

Investigators ^ICMJE

Principal Investigator:

Paresh Dandona, MBBS

SUNY at Buffalo

PRS Account

Kaleida Health

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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