The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

This study has been completed.
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Juraj Koska, Carl T. Hayden VA Medical Center Identifier:
First received: August 13, 2010
Last updated: April 10, 2013
Last verified: April 2013

The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to determine how this occurs. The results of this study will help to determine and understand a novel action of this group of diabetes medications based on the action of naturally occuring gut substances called incretins. This may have a significant impact on cardiovascular health in patients with early and longstanding diabetes.

Condition Intervention
Type 2 Diabetes Mellitus
Drug: Exenatide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms

Resource links provided by NLM:

Further study details as provided by Carl T. Hayden VA Medical Center:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: Days 1 or 11 of intervention ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postprandial endothelial dysfunction Drug: Exenatide
Exenatide 5-10 ug sc BID/10 days
Experimental: Fasting endothelial function Drug: Exenatide
Exenatide iv for 45 minutes


Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • US Veterans
  • type 2 diabetes mellitus (T2D) diagnosed within 3 years with good glycemic control on diet, metformin, or sulfonylurea agents or combinations of these agents (HbA1c ≤8.0%)
  • T2D diagnosed ≥ 5 years prior to study enrollment
  • Impaired glucose tolerance

Exclusion Criteria:

  • T2D not meeting inclusion above criteria for duration of diabetes or HbA1c values
  • known or suspected T1D (early onset age, low body mass index, lack of family history)
  • TZD use in the prior 3 months
  • prior regular use of insulin
  • Creatinine >2.0 mg/dl or other laboratory or clinical evidence of kidney disease
  • anemia
  • known active liver disease or hepatic enzyme elevation two-and-a half times above normal
  • acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
  • stable or unstable angina or other major illness in the past 6 months
  • Raynaud's disease or any rheumatic disease affecting fingers
  • current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day);
  • subjects receiving lipid lowering or anti-hypertension medications must be on stable doses for at least 2 months prior to participation.
  Contacts and Locations
Please refer to this study by its identifier: NCT01181986

United States, Arizona
Phoenix VA Medical Center
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Carl T. Hayden VA Medical Center
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Principal Investigator: Juraj Koska, MD, PhD Phoenix VA Healthcare System
  More Information

No publications provided

Responsible Party: Juraj Koska, Research Health Scientist, Carl T. Hayden VA Medical Center Identifier: NCT01181986     History of Changes
Other Study ID Numbers: 1-10-CT-31
Study First Received: August 13, 2010
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Carl T. Hayden VA Medical Center:
Type 2 diabetes mellitus, Impaired glucose tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014