Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/11/2006
Date assigned
29/11/2006
Last edited
20/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karen Lam

ORCID ID

Contact details

The University of Hong Kong
Queen Mary Hospital
Pokfulam
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HKCTR-1

Study information

Scientific title

Acronym

Study hypothesis

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

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).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Rosiglitazone and sulphonylurea

Primary outcome measures

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 trial start date

23/03/2004

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

68

Participant 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

Recruitment start date

23/03/2004

Recruitment end date

01/04/2006

Locations

Countries of recruitment

Hong Kong

Trial participating centre

The University of Hong Kong
Pokfulam
-
Hong Kong

Sponsor information

Organisation

Hong Kong University Research Committee (Hong Kong)

Sponsor details

7/F.
Shui On Centre
6-8 Harbour Road
Wanchai
-
Hong Kong

Sponsor type

Research organisation

Website

Funders

Funder type

University/education

Funder name

Hong Kong University Research Committee (Hong Kong) (project no. HKU 7637/05M)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

HK Innovation and Technology Support Programme (Hong Kong) (project no. ITS/048/03)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17639302

Publication citations

  1. Results

    Tan KC, Chow WS, Tso AW, Xu A, Tse HF, Hoo RL, Betteridge DJ, Lam KS, Thiazolidinedione increases serum soluble receptor for advanced glycation end-products in type 2 diabetes., Diabetologia, 2007, 50, 9, 1819-1825, doi: 10.1007/s00125-007-0759-0.

Additional files

Editorial Notes