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COMPLETEDPHASE4

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

NCT01474018•University of Texas Southwestern Medical Center

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.

Detailed Description

To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.

Eligibility

Age

30 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male and female patients, age 30 to 65 years of age,
•2. Clinical diagnosis of type 2 diabetes at least 6 months prior to enrollment,
•3. Stable on current treatment consisting of either human or recombinant multi-dose insulin therapy (MDI) with metformin,
•4. HbA1c of 7.5-12%, inclusive,
•5. Demonstrated willingness to check and record blood glucose readings at seven time points as instructed in the study protocol.
•6. Medically controlled hypertension, at least on one anti-hypertensive
•7. Medically controlled hyperlipidemia, on or off cholesterol-lowering therapy
•8. BMI \>30

Exclusion Criteria

•1. Pregnancy or Lactating,
•2. Type 1 Diabetes,
•3. Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,
•4. Patients with history of drug or alcohol abuse within 3 years of enrollment,
•5. Patients at risk for hypotension, including those who have:
•* Recent blood donation within 30 days of enrollment,
•* A history of syncopal migraines, or
•* Significant gastroparesis or orthostatic hypotension which could signify advanced autonomic neuropathy.
•6. Uncontrolled mental illness especially with history of psychosis,
•7. Any severe, uncontrolled or terminal medical condition which the investigator feels would interfere with the patient's ability to participate and comply with the study protocol,
+4 more criteria

Locations (2)

UT Southwestern Medical Center

Dallas, Texas, United States

UT Southwestern

Dallas, Texas, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

May 1, 2012

Completion Date

June 1, 2012

Last Updated

September 16, 2019

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

QR-bromocriptine

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)