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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: QR-bromocriptine

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • UT Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Metformin + Insulin; 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; study drug add-on the usual therapy	Drug: 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.; Other Names: NDC 6801225820; Cycloset (brand)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Philip Raskin, MD, UTexas Southwestern

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 2, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Dopamine Agonists; Dopamine Agents; Hormone Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Bromocriptine
• Other Study ID Numbers: QR-Bromo