MedTrace Logo

Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes

NCT00377676 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3095

Last updated 2016-06-10

Study results available
· View outcomes & findings →

Summary

Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities.

The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well.

Conditions

Interventions

DRUG

Cycloset

Usual diabetes therapy plus Cycloset

DRUG

Usual Diabetes Therapy plus placebo

Placebo tablet taken orally once in the morning, beginning with one tablet daily, titrated up by 1 tablet each week to a maximum of 6 tablets daily

Sponsors & Collaborators

  • VeroScience

    lead INDUSTRY

Principal Investigators

  • Michael Gaziano · MAVERIC

  • Richard E Scranton, MD MPH · VeroScience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-01-31
Completion
2007-01-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00377676 on ClinicalTrials.gov