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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01474018
First received: November 2, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: QR-bromocriptine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Change in A1C%, from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison of the change from baseline in HbA1c over 6 months between those subjects receiving QR-Bromocriptine as compared to those subjects receiving usual therapy.


Enrollment: 15
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474018

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
UT Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Philip Raskin, MD UTexas Southwestern
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01474018     History of Changes
Other Study ID Numbers: QR-Bromo
Study First Received: November 2, 2011
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bromocriptine
Insulin, Globin Zinc
Insulin
Metformin
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 27, 2014