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

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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: QR-bromocriptine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Metformin + Insulin<br>5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling. | |
| Experimental: QR-Bromocriptine +metformin+insulin<br>study drug add-on the usual therapy | Drug: QR-bromocriptine<br>* 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.<br>* Other names: Cycloset (brand);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Daily Insulin Dose | Change in total daily insulin dose in patients treated with QR-Bromocriptine +metformin +insulin compared to metformin + insulin alone | Baseline - 24 weeks |