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Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
rosiglitazone
glyburide
Sponsored by
St. Paul Heart Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring thiazolidinedione, sulfonylurea, endothelial function

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Paul Heart Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosiglitazone

Glyburide

Arm Description

Outcomes

Primary Outcome Measures

Flow Mediated Dilation
Measure of endothelial function

Secondary Outcome Measures

Full Information

First Posted
July 21, 2005
Last Updated
June 26, 2013
Sponsor
St. Paul Heart Clinic
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00123643
Brief Title
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Official Title
Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Paul Heart Clinic
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
thiazolidinedione, sulfonylurea, endothelial function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosiglitazone
Arm Type
Experimental
Arm Title
Glyburide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Intervention Type
Drug
Intervention Name(s)
glyburide
Primary Outcome Measure Information:
Title
Flow Mediated Dilation
Description
Measure of endothelial function
Time Frame
change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Bank, M.D.
Organizational Affiliation
St. Paul Heart Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul Heart Clinic
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States

12. IPD Sharing Statement

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Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

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