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

Study Overview
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Brief Summary
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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).

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes Mellitus and Nephropathy

Conditions
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Type 2 Diabetes, Nephropathy

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0954, losartan / Duration of Treatment: mean 3.4 years|nan|
|Drug: Placebo / Duration of Treatment: mean 3.4 years|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint of doubling of serum creatinine, ESRD or death. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary parameters: number of cardiovascular events and changes in proteinuria. Tertiary parameters: quality of life and healthcare resource utilization. |  |  |