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

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: exenatide 5 mcg Drug: exenatide 10 mcg Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by Kaleida Health:

Primary Outcome Measures:

insulin dose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.


Enrollment:	63
Study Start Date:	April 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: exenatide 5 mcg exenatide 5 mcg	Drug: exenatide 5 mcg exenatide 5 mcg
Experimental: exenatide 10 mcg exenatide 10 mcg	Drug: exenatide 10 mcg exenatide 10 mcg
Placebo Comparator: placebo placebo	Drug: placebo saline sq

Eligibility


Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154933

Locations


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

Sponsors and Collaborators

Kaleida Health

Amylin Pharmaceuticals, LLC.

Investigators


Principal Investigator:	Paresh Dandona, MBBS	SUNY at Buffalo

More Information


Responsible Party:	Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier:	NCT01154933 History of Changes
Other Study ID Numbers:	1930
Study First Received:	June 30, 2010
Last Updated:	December 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Kaleida Health:


type 2 diabetes obesity

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide	Insulin Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016

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