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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: QR-bromocriptine

Study type: Interventional

Funder types: Other

Identifiers

NCT01474018

QR-Bromo

Details and patient eligibility

About

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.

Full description

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

Enrollment: 15 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Metformin + Insulin

No Intervention group

Description:

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 group

Description:

study drug add-on the usual therapy

Treatment:

Drug: QR-bromocriptine