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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: QR-bromocriptine

• Registration Number: NCT01474018
• Lead Sponsor: University of Texas Southwestern Medical Center

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Results First Submitted: 2019-01-07
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Results First Posted: 2019-09-16
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QR-Bromocriptine +metformin+insulin	QR-bromocriptine	study drug add-on the usual therapy

Primary Outcome Measures

Name	Time	Method
Change in A1c	Baseline - 24 weeks	Change from baseline HbA1c between subjects receiving QR-Bromocriptine + metformin + insulin compared to those subjects receiving metformin + insulin

Secondary Outcome Measures

Name	Time	Method
Total Daily Insulin Dose	Baseline - 24 weeks	Change in total daily insulin dose in patients treated with QR-Bromocriptine +metformin +insulin compared to metformin + insulin alone

Trial Locations

Locations (2)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

UT Southwestern; 🇺🇸 Dallas, Texas, United States