Clinical trial NCT01474018: QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Official title: QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in A1c
timeFrame: Baseline - 24 weeks
Secondary outcomes:
measure: Total Daily Insulin Dose
timeFrame: Baseline - 24 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: UTexas Southwestern
name: Philip Raskin, MD
role: PRINCIPAL_INVESTIGATOR
References: