Troglitazone in Diabetes Mellitus and Atherosclerosis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: troglitazone

Detailed Description

Insulin resistance and hyperinsulinism appear to be important risk factors for the development of atherosclerosis in diabetes patients. The atherogenic potential of insulin has been shown to improve cholesterol and may have an effect on the thickness and structure of the arterial wall. Troglitazone is an oral diabetic agent that treats insulin resistance. Based on the initial data available, it would appear that troglitazone may be effective in both glycemic control and improved atherosclerosis risk in diabetes patients. This study will compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both glycemic control and progression of atherosclerosis.

A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet, exercise, insulin dose and glucose levels. Upon successful completion of the run-in phase, all patients were randomized into one of two groups to receive either troglitazone 400mg/day or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mg/dL.

Follow up visits occurred every 2 weeks for 2 months, every 4 weeks for 2 months, then every 8 weeks for the remainder of the 2-year trial. The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment.

Study Type

Interventional

Enrollment

288

Phase

Phase 2
Phase 3

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
- California
  - Los Angeles, California, United States, 90033
    - Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men and women ages 30-70 years
Diabetes: fasting glucose over 140 mg/dL but under 350 mg/dL on at least 2 occasions
At least 30 years of age at onset of diabetes
Metabolic control and management requiring insulin without other anti-diabetic medications
Willingness to sign informed consent

Exclusion Criteria:

Known sensitivity to troglitazone or other thiazolidinediones
For premenopausal females: pregnancy, breastfeeding, unwilling to use effective contraception for the duration of the trial
Active liver disease or hepatic dysfunction; renal dysfunction; high blood pressure; major vascular events within 6 months prior to randomization; untreated hypothyroidism or uncured hyperthyroidism; other severe or unstable disease within 5 years of randomization
Medical illness that may require oral or parenteral glucocorticoid therapy
Physical disability that would interfere with diabetes self-management
Untreated or unstable diabetic retinopathy
History of insulin allergy
Present or recent history of alcohol intake over 5 drinks per day or substance abuse
Participation in another clinical trial
Currently taking nicotinic acid

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months
flow mediated brachial artery vasoactivity

Secondary Outcome Measures

Outcome Measure
carbohydrate and lipid metabolism

Collaborators and Investigators

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

Sponsor

Parke-Davis

Investigators

Principal Investigator: Howard N. Hodis, MD, University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

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

January 1, 1997

Primary Completion (Actual)

April 1, 2000

Study Completion (Actual)

April 1, 2000

Study Registration Dates

First Submitted

June 29, 2005

First Submitted That Met QC Criteria