QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: QR-bromocriptine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
Philip Raskin, MD, Principal Investigator, Affiliation: UTexas Southwestern
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.
Clinical Details
Official title: QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in A1C%, from baseline
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.
Eligibility
Minimum age: 30 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
UT Southwestern, Dallas, Texas 75390, United States
UT Southwestern Medical Center, Dallas, Texas 75390, United States
Additional Information
Starting date: November 2011
Last updated: May 20, 2014
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