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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
History of Changes

November 2, 2011
May 20, 2014
November 2011
May 2012   (final data collection date for primary outcome measure)
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.
Decline in A1C% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
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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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
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.
Both
30 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474018
QR-Bromo
Yes
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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