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

Tracking Information
First Submitted Date ICMJE	November 2, 2011
First Posted Date ICMJE	November 17, 2011
Last Update Posted Date	May 22, 2014
Study Start Date ICMJE	November 2011
Actual Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 20, 2014)	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.
Original Primary Outcome Measures ICMJE; (submitted: November 14, 2011)	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.
Change History	Complete list of historical versions of study NCT01474018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Official Title ICMJE	QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
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.
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 ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus, Type 2
Intervention ICMJE	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)
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 14, 2011)	15
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2012
Actual Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male and female patients, age 30 to 65 years of age,; Clinical diagnosis of type 2 diabetes at least 6 months prior to enrollment,; Stable on current treatment consisting of either human or recombinant multi-dose insulin therapy (MDI) with metformin,; HbA1c of 7.5-12%, inclusive,; Demonstrated willingness to check and record blood glucose readings at seven time points as instructed in the study protocol.; Medically controlled hypertension, at least on one anti-hypertensive; Medically controlled hyperlipidemia, on or off cholesterol-lowering therapy; BMI >30 Exclusion Criteria: Pregnancy or Lactating,; Type 1 Diabetes,; Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,; Patients with history of drug or alcohol abuse within 3 years of enrollment,; 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.; Uncontrolled mental illness especially with history of psychosis,; 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,; Serum creatinine >1.4mg/dL in females or >1.5mg/dL in males that would preclude the patient from taking metformin,; LFTs elevated >3x upper limit of normal,; Patients working rotating, varying or night shifts, or; 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	30 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01474018
Other Study ID Numbers ICMJE	QR-Bromo
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Texas Southwestern Medical Center
Study Sponsor ICMJE	University of Texas Southwestern Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Philip Raskin, MD UTexas Southwestern
PRS Account	University of Texas Southwestern Medical Center
Verification Date	May 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP