Type II Diabetes Mellitus MedDRA version: 7.0 Level: PT Classification code 10012613
Conditions
Interventions
Trade Name: PRETERAX
Product Name: Preterax
Product Code: S05590-F31
Pharmaceutical Form: Tablet
INN or Proposed INN: perindopril
CAS Number: 82834-16-0
Current Sponsor code: S09490-03
Concentration u
Sponsors
Institut de Recherches Internationales Servier
Institute for International Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 55 years old or over with type 2 diabetes (diagnosis of diabetes made at age 30 years or older, and no requirement for regular insulin therapy). - A substantially elevated risk of cardiovascular disease, indicated by: a history of major macrovascular or microvascular disease, a first diagnosis of type 2 diabetes made 10 or more years prior to entry, age 65 years or over or other defined major risk factor for vascular disease. - Informed signed consent. - No definite and specific contraindication or indication for any of the study treatments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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, or contraindication to, treatment with gliclazide. - A definite and specific indication for, or contraindication to, a haemoglobin A1c control target of 6.5% or less - A definite indication for long-term therapy with full-dose or bed-time insulin - Participation in another 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary outcomes include other major events, cognitive function and quality of life. ;Primary end point(s): 1.The composite of non-fatal stroke, non-fatal myocardial infarction and death from any cardiovascular cause 2.The composite of new or substantially worsening nephropathy or microvascular eye disease;Main Objective: To determine the effects of a fixed low-dose perindopril-indapamide combination (2mg/0.625mg) vs placebo and a modified-release gliclazide (30-120mg)-based intensive glucose lowering regimen vs standard guidelines-based therapy on major macrovascular and microvascular complications among individuals with type 2 diabetes over a scheduled mean treatment period of 4.5 years. | — |
Countries
Ireland
Outcome results
None listed