Status:
COMPLETED
Blood Pressure and Glucose Lowering for the Prevention of Vascular Disease in High Risk Patients With Type 2 Diabetes
Lead Sponsor:
The George Institute
Collaborating Sponsors:
Institut de Recherches Internationales Servier
University of Sydney
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
55-110 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to provide information on the risks and benefits of routine blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood glucose levels, i...
Detailed Description
Patients with type 2 diabetes are at increased risks of macrovascular and microvascular disease, both of which are reduced by control of raised blood pressure in hypertensive individuals. Intensive gl...
Eligibility Criteria
Inclusion
- A diagnosis of type 2 diabetes mellitus first made at age 30 years or older
- Age 55 years or older at entry
- Ability to provide informed consent
- A substantially elevated risk of cardiovascular disease, indicated by:
- A history of major macrovascular disease defined as any one of: stroke, myocardial infarction, hospital admission for transient ischaemic attack, hospital admission for unstable angina, coronary artery bypass graft, percutaneous transluminal coronary angioplasty (with or without stenting), peripheral revascularisation (angioplasty or surgery) or amputation secondary to vascular disease or
- A history of major microvascular disease defined as any one of nephropathy (albumin:creatinine ratio \>300ug/mg), retinal photocoagulation therapy, proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or elsewhere), macular oedema (retinal thickening within one disc diameter of the macular centre) or blindness in either eye (corrected visual acuity 6/60 or worse, persisting for three months or more) not known to be due to non-diabetic causes or
- A first diagnosis of type 2 diabetes made 10 or more years prior to entry or
- Another major risk factor for vascular disease defined as any one of: current daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or without cholesterol lowering treatment), HDL cholesterol \<1.0 mmol/l, microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or
- Age 65 years or over
Exclusion
- A definite contraindication to treatment with an ACE inhibitor or a thiazide-like diuretic
- A specific indication for treatment with an ACE inhibitor other than perindopril 2-4 mg daily (see also section 5.2.3) or a thiazide-like diuretic
- A definite and specific indication for treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
- A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
- A definite indication for long-term full-dose or bed-time insulin therapy
- Participation in a trial within the month prior to the Registration Visit or current participation in another trial
- Other potential reasons for ineligibility include:
- High probability of non-adherence to study treatment or follow-up
- Current clinical instability (e.g. a major cerebral or coronary event or sight-threatening retinopathy or macular oedema within the previous few weeks)
- Life threatening non-vascular disease other than diabetes and its complications
- Moderate or severe dementia
- Major disability that is likely to prevent regular attendance at study clinics
- Final decisions about eligibility were made at the discretion of the study investigator and the potential study participant, in the light of any requirements or guidance from local ethics committees and other regulatory bodies.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
11140 Patients enrolled
Trial Details
Trial ID
NCT00145925
Start Date
June 1 2001
End Date
March 1 2008
Last Update
April 11 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Melbourne
Melbourne, Victoria, Australia, 3010
2
University of Montreal
Montreal, Quebec, Canada, H26 1X2
3
Cardiovascular Institute & Fu Wai Hospital
Beijing, Beijing Municipality, China, 100037
4
The Julius Center for Health Sciences and Primary Care
Utrecht, Utrecht, Netherlands, 3508 BA