Effect of rosiglitazone, compared to sulphonylurea, on endothelial function in Chinese patients with type two diabetes

Completed

• Conditions: Type two diabetes; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN05215453
• Lead Sponsor: Hong Kong University Research Committee (Hong Kong)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Chinese men and women aged 30 to 70 years
2. Type two diabetes (defined by the World Health Organization [WHO] criteria) diagnosed after 30 years of age
3. On diet with/without sulphonylurea (less than or equal to half-maximum dose) with/without metformin for at least six months
4. No change in anti-diabetic, lipid lowering and anti-hypertensive in preceding 12 weeks
5. Body Mass Index (BMI) more than or equal to 23 and less than or equal to 35 kg/m^2
6. Systolic blood pressure less than or equal to 160 mmHg and diastolic blood pressure less than or equal to 90 mmHg
7. HbA1c levels between 7.5 and 10.5% inclusively (normal less than or equal to 6.1%) on at least two occasions in the past three months
8. Female patients must be post-menopausal (i.e. more than six months without menstrual period), surgically sterilised, or using hormonal contraceptives or intrauterine devices

Exclusion Criteria

1. Pregnancy or lactation
2. Any clinically significant abnormality identified on the screening physical examination, laboratory tests, or electrocardiogram which, in the judgement of the investigator, would preclude the safe completion of the study
3. Use of anti-diabetic drugs other than metformin or sulphonylurea within 12 weeks
4. Use of any investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
5. Patients with a documented history of significant hypersensitivity to any drugs including thiazolidinedione and sulphonylurea (e.g., difficulty in swallowing or breathing, or tachycardia)
6. Active alcohol or drug abuse within the last six months
7. Presence of clinically significant renal or hepatic disease:
7.1. Serum creatinine above Upper Normal Range (UNR) (creatinine more than 128 umol/L for males and more than 107 umol/L for females)
7.2. Proteinuria more than 1 gm/day
7.3. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), total bilirubin, or alkaline phosphatase more than two times above UNR
8. Significant anaemia (haemoglobin less than 11 g/dl for males or less than 10 g/dl for females)
9. Patients with haemoglobinopathies
10. Leukocyte count less than 3.0 x 10^9/L or platelet count less than 120 x 10^9/L
11. Patients with severe angina, coronary insufficiency, heart failure (New York Heart Association [NYHA] class III or IV), or history of cardiovascular event in the past six months
12. Patients with electrocardiographic evidence of left ventricular hypertrophy based upon the maximal voltage of Sv1 plus the maximal voltage of Rv5 or Rv6 more than 3.5 mV and ST-T segment changes
13. Symptomatic diabetic neuropathy of sufficient severity to require treatment for control of symptoms (e.g. painful peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, pedal ulcers, gastric stasis, etc.)
14. Patients with history of psychiatric illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified