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

NCT ID: NCT01474018

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-06-30

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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin + Insulin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

QR-Bromocriptine +metformin+insulin

study drug add-on the usual therapy

Group Type: EXPERIMENTAL

QR-bromocriptine

Intervention Type: 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.

Interventions

QR-bromocriptine

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.

Intervention Type: DRUG

Other Intervention Names

NDC 6801225820; Cycloset (brand)

Eligibility Criteria

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,

8. Serum creatinine >1.4mg/dL in females or >1.5mg/dL in males that would preclude the patient from taking metformin,

9. LFTs elevated >3x upper limit of normal,

10. Patients working rotating, varying or night shifts, or

11. 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Raskin, MD

Role: PRINCIPAL_INVESTIGATOR

UTexas Southwestern

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

UT Southwestern

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

QR-Bromo

Identifier Type: -

Identifier Source: org_study_id