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
  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:


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
Other Name: exenatide 5 mcg
Experimental: exenatide 10 mcg
exenatide 10 mcg
Drug: exenatide 10 mcg
exenatide 10 mcg
Other Name: exenatide 10 mcg
Placebo Comparator: placebo
placebo
Drug: placebo
saline sq
Other Name: placebo

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
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

No publications provided

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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014