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
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

November 2, 2011
November 17, 2011
May 22, 2014
November 2011
May 2012   (Final data collection date for primary outcome measure)
Change in A1C%, from baseline [ Time Frame: 6 months ]
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.
Decline in A1C% [ Time Frame: 6 months ]
Decline in A1c % over 6-month treatment period in patients on baseline therapy with insulin and metformin, randomized to receive either QR-Bromocriptine or continue with usual therapy.
Complete list of historical versions of study NCT01474018 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
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.
To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
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)
  • 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
    Intervention: Drug: QR-bromocriptine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Philip Raskin, MD UTexas Southwestern
University of Texas Southwestern Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP