Type 2 diabetes mellitus MedDRA version: 20.0 Level: LLT Classification code 10052912 Term: Cardiovascular disorder prophylaxis System Organ Class: 100000004865 MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Enalapril maleate
Product Code: Not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Enalapril
CAS Number: 758
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type-2 diabetes mellitus - diagnosed for at least six months prior to inclusion 2) = 18 years of age, male or female 3) Written informed consent to participate in the study and ability to comply with the study requirements. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance to high dose of RAAS-antagonists or beta-blocker in the absence of any other blood pressure lowering drugs. 2) Patients already receiving a maximum dose of RAAS-antagonists or beta-blocker. 3) Creatinine > 2.5mg/dl. 4) Symptomatic hypotension and/or systolic blood pressure (SBP) grades I. 8) Coronary artery disease, defined by a history of myocardial infarction, known coronary stenosis > 70% detected either by angiography or by CT-scan, significant defects in myocardial scintigraphy or positive stress-test echocardiography. 9) A disease other than diabetes lowering the patient’s life expectancy to less than two years. 10) Chronic infections or malignancies. 11) Systemic treatment with corticosteroids. 12) Renal replacement therapy. 13) Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels >40mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, and oral), and double-barrier methods (if accepted by local regulatory authority and ethics committee). Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 14) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test ( > 5mIU/ml). 15) History of noncompliance to medical regimes and patients who are considered potentially unreliable. 16) Current double blind treatment in diabetic trials. 17) Participation in an investigational drug study at the time of enrollment or within the past 90 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Does the treatment reduce the number of unplanned hospitalization or death due to a cardiac event. Is there a relation between this and plasma NT-proBNP concentration. ;Primary end point(s): Combined endpoint based on the first occurance of cardiac death and cardiac hospitalisation.;Timepoint(s) of evaluation of this end point: This is an intention to treat study therefore endpoints will be assessed following patient consent.;Main Objective: To evaluate the effect of high dose Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM) with no evidence of a pre-existing cardiac disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: This is an intention to treat study therefore endpoints will be assessed following patient consent.; Secondary end point(s): 1) All cardiac hospitalization 2) Heart failure hospitalization 3) All cause hospitalization 4) NT-proBNP 5) Other predefined biomarkers (see section plasma and serum biomarkers) 6) Health economic analysis (cost-effectiveness of intervention considering both life-years and quality of life adjusted life years) | — |
Countries
Austria, New Zealand, Spain, United Kingdom, United States
Contacts
Public ContactThomas Kastenbuer
MEDtest Medical Consulting
Outcome results
None listed