Type 2 Diabetes Mellitus
Conditions
Keywords
thiazolidinedione, sulfonylurea, endothelial function
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.
Interventions
DRUGrosiglitazone
DRUGglyburide
Sponsors
GlaxoSmithKline
St. Paul Heart Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation | change from baseline to 6 months | Measure of endothelial function |
Countries
United States
Participant flow
Recruitment details
recruitment was performed at medical clinics
Pre-assignment details
patients taking thiazolidinediones or sulfonylureas were allowed to washout of these medications 30 days prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Rosiglitazone | 20 |
| Glyburide | 16 |
| Total | 36 |
Baseline characteristics
| Characteristic | Glyburide | Rosiglitazone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 4 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 16 Participants | 24 Participants |
| Age Continuous | 63.1 years STANDARD_DEVIATION 7.8 | 57.9 years STANDARD_DEVIATION 8.2 | 60.2 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 16 participants | 20 participants | 36 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 16 |
| serious Total, serious adverse events | 0 / 20 | 0 / 16 |
Outcome results
Primary
Flow Mediated Dilation
Measure of endothelial function
Time frame: change from baseline to 6 months
Population: All completers were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosiglitazone | Flow Mediated Dilation | 6.8 percent change | Standard Deviation 3.7 |
| Glyburide | Flow Mediated Dilation | 5.5 percent change | Standard Deviation 3.1 |