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

NCT01474018 | Completed Phase 4 Results DMC

• 1 other identifier: QR-Bromo
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in A1c

  Change from baseline HbA1c between subjects receiving QR-Bromocriptine + metformin + insulin compared to those subjects receiving metformin + insulin

  Baseline - 24 weeks

Secondary Outcomes (1)

• Total Daily Insulin Dose

  Baseline - 24 weeks

Study Arms (2)

Metformin + Insulin

NO INTERVENTION

5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling.

QR-Bromocriptine +metformin+insulin

EXPERIMENTAL

study drug add-on the usual therapy

Drug: QR-bromocriptine

Interventions

QR-bromocriptine DRUG

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.

Also known as: NDC 6801225820, Cycloset (brand)

QR-Bromocriptine +metformin+insulin

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or Lactating,
• Type 1 Diabetes,
• Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,
• Patients with history of drug or alcohol abuse within 3 years of enrollment,
• 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.
• Uncontrolled mental illness especially with history of psychosis,
• 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,
• Serum creatinine \>1.4mg/dL in females or \>1.5mg/dL in males that would preclude the patient from taking metformin,
• LFTs elevated \>3x upper limit of normal,
• Patients working rotating, varying or night shifts, or
• Patient with circumstances or abnormalities (e.g. blindness or history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Erin D. Roe
• Organization: Baylor Endocrine Center

edr@roemd.com

214-820-3466

Study Officials

• Philip Raskin, MD

  UTexas Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-09

Locations

US (2)