Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123643
• Other study ID #: GSK2002-2
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2005
• Last updated: June 26, 2013
• Start date: May 2003
• Est. completion date: December 2005

Study information

• Verified date: June 2013
• Source: St. Paul Heart Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.

Description:

Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have different effects on the health of the blood vessels. This study will assess which medication is better at improving the health of the arteries separate from the blood glucose lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 25-75 years

• Type 2 diabetes mellitus for less than or equal to 10 years

• Pre-screening HbA1c > 6.5 %

• Screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)

Exclusion Criteria:

• Thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)

• Known contraindications to use of thiazolidinedione or sulfonylurea

• Female patients must be postmenopausal, surgically sterile, or using adequate contraception

• Uncontrolled hyperlipidemia according to American Heart Association (AHA) guidelines

• Subcutaneous insulin use

• Elevated liver enzymes (2.5 times the upper limit of the reference range)

• Serum creatinine >160 mmol/l

• Anemia (Hb <11 g/dl for men or <10 g/dl for women)

• Body mass index (BMI) <22 or >42 kg/m2

• History of ketoacidosis

• Angina/New York Health Academy class III/IV cardiac insufficiency

• Electrocardiographic evidence of marked left ventricular hypertrophy

• Uncontrolled hypertension according to AHA guidelines

• Hemoglobinopathy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• rosiglitazone

• glyburide

Locations

Country	Name	City	State
United States	St. Paul Heart Clinic	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
St. Paul Heart Clinic	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilation	Measure of endothelial function	change from baseline to 6 months	No