At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 15 enrolled

Drug / intervention

QR-bromocriptinedrug

Likely dose

QR-bromocriptine 0.8mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01474018

NCT01474018Phase 4Completed

Compare CT.gov

QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes

University of Texas Southwestern Medical Center·interventional·Posted Nov 17, 2011·Updated Sep 16, 2019

In Brief

A Phase 4 clinical trial evaluating QR-bromocriptine for Diabetes Mellitus, Type 2. Completed, enrolled 15 participants across 2 sites.

Detailed Summary

QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2 diabetes will result in improved glycemic control, reduced exogenous insulin requirement, increased lean fat mass and improved pancreatic beta-cell function.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetes Mellitus, Type 2

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartNov 2011

First PostedNov 2011

Primary CompletionMay 2012

Study CompletionJun 2012

TodayJul 2026

First PostedNov 17, 2011

Enrollment StartNov 1, 2011

Primary CompletionMay 1, 2012

Study CompletionJun 1, 2012

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 14.6 years ago

Interventions

QR-bromocriptinedrug

The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.