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.
|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|
- 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.
|Study Start Date:||November 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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
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.
To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Philip Raskin, MD||UTexas Southwestern|