QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT01474018 |
Recruitment Status
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Completed
First Posted
: November 17, 2011
Last Update Posted
: May 22, 2014
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Sponsor:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
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.
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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 |
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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:
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |