A Research Study to Evaluate the Renal (Kidney) Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes (0954-147)(COMPLETED)

Organon

Status and phase

Completed

Phase 3

Conditions

Nephropathy

Type 2 Diabetes

Treatments

Drug: Placebo / Duration of Treatment: mean 3.4 years

Drug: MK0954, losartan / Duration of Treatment: mean 3.4 years

Study type

Interventional

Funder types

Industry

Identifiers

NCT00308347

0954-147

2006_020

Details and patient eligibility

About

Evaluate the effect of Losartan in reducing kidney disease in patients with Non-insulin Dependent Diabetes and Nephropathy (kidney damage that usually accompanies late stage Diabetes Mellitus).

Enrollment

1,513 patients

Sex

All

Ages

31 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diabetes diagnosed after the age of 30
Insulin not required within 6 months of first being diagnosed with Non-insulin Dependent Diabetes Mellitus
No history of diabetic ketoacidosis
Patients may be currently treated with diet, oral hypoglycemics or insulin
Patients must have proteinuria defined as: Urine protein >1+ on dipstick at the initial screening visit
Patients with hypertension (high blood pressure) must have a sitting blood pressure >200/110 mm Hg at Visit 1

Exclusion criteria

Patients with insulin-dependent diabetes mellitus (juvenile onset)
Patients treated with an ACE inhibitor or angiotensin II antagonist (AIIA) for >5 years
Patients treated with ACE inhibitor or AIIA therapy for 5 years or less may enter the study provided therapy is discontinued during the 6 week screening period prior to randomization
History of myocardial infarction (MI) (heart attack) or coronary artery bypass graft (CABG) surgery within the past 1 month
History of cerebral vascular accident (CVA) (stroke) or percutaneous transluminal coronary angioplasty (PTCA) within the past 6 months
History of transient ischemic attacks (TIA) within the past year. Patients with unstable angina are excluded until stabilized
Heart failure requiring ACE inhibitor therapy
Steroids (oral or parenteral) or immunosuppressives are not permitted. Debilitating psychological illness
Evidence of significant hepatic (liver) dysfunction: History of allergy to losartan
Known positive test for HIV or patients known to be hepatitis B or C antigen carriers
Pregnant or nursing women
Females of childbearing age must either be surgically sterilized or, if sexually active, using an effective form of contraception and may enter only if an exclusionary pregnancy test is done within approximately 72 hours prior to randomization
Pregnancy tests will be done every 3 months during the study and at the time of discontinuation