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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01474018
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: QR-bromocriptine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Study Start Date : November 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

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)

Primary Outcome Measures :
  1. Change in A1c [ Time Frame: Baseline - 24 weeks ]
    Change from baseline HbA1c between subjects receiving QR-Bromocriptine + metformin + insulin compared to those subjects receiving metformin + insulin

Secondary Outcome Measures :
  1. Total Daily Insulin Dose [ Time Frame: Baseline - 24 weeks ]
    Change in total daily insulin dose in patients treated with QR-Bromocriptine +metformin +insulin compared to metformin + insulin alone

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01474018

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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
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Principal Investigator: Philip Raskin, MD UTexas Southwestern
  Study Documents (Full-Text)

Documents provided by University of Texas Southwestern Medical Center:
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Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT01474018    
Other Study ID Numbers: QR-Bromo
First Posted: November 17, 2011    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action