Effect of rosiglitazone, compared to sulphonylurea, on endothelial function in Chinese patients with type two diabetes
| ISRCTN | ISRCTN05215453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05215453 |
| Secondary identifying numbers | HKCTR-1 |
- Submission date
- 14/11/2006
- Registration date
- 29/11/2006
- Last edited
- 20/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Karen Lam
Scientific
Scientific
The University of Hong Kong
Queen Mary Hospital
Pokfulam
-
Hong Kong
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. Rosiglitazone improves endothelial function independent of its effect on glycemic control 2. Rosiglitazone affects soluble receptor of advanced glycation end products independent of its effect on glycemic control |
| Ethics approval(s) | Ethics approval received from the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster on the 19th March 2004 (ref: UW 04-045 T/367). |
| Health condition(s) or problem(s) studied | Type two diabetes |
| Intervention | Patients were randomised to receive add-on therapy with either rosiglitazone 4 mg or glibenclamide 5 mg (or gliclazide 80 mg) daily while keeping the doses of their usual anti-diabetic agents constant. After four weeks, the doses of the add-on therapy were doubled in subjects with fasting blood glucose level greater than 8.0 mmol/l and without symptomatic or asymptomatic hypoglycemia defined as blood glucose level less than 3.0 mmol/l. The dosages of all anti-diabetic agents were then kept constant for another 20 weeks. There was no washout period and all study medications were administered orally. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rosiglitazone and sulphonylurea |
| Primary outcome measure | Changes in endothelial function in patients with type two diabetes |
| Secondary outcome measures | 1. Changes in blood pressure and metabolic parameters such as C-reactive protein. 2. Changes in serum soluble Receptor for Advanced Glycation End products (sRAGE) and advanced glycation end products. |
| Overall study start date | 23/03/2004 |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 68 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/03/2004 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
The University of Hong Kong
Pokfulam
-
Hong Kong
-
Hong Kong
Sponsor information
Hong Kong University Research Committee (Hong Kong)
Research organisation
Research organisation
7/F., Shui On Centre
6-8 Harbour Road
Wanchai
-
Hong Kong
"ROR" |
https://ror.org/02zhqgq86 |
|---|
Funders
Funder type
University/education
Hong Kong University Research Committee (Hong Kong) (project no. HKU 7637/05M)
No information available
HK Innovation and Technology Support Programme (Hong Kong) (project no. ITS/048/03)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2007 | Yes | No |
