A DOUBLE-BLIND, RANDOMLY CONTROLLED PLACEBO STUDY TO EVALUATE THE RENAL PROTECTIVE EFFECTS OF LOSARTAN IN PATIENTS WITH DIABETES MELLITUS NON-INSULIN DEPENDENTS AND NEPHROPATHY

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-077-00
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-09-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Combined endpoint of doubling of serum creatinine, ESRD or death.<br>Measure:Doubling of serum level of creatinine<br>Timepoints:At the end of treatment or death<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:number of cardiovascular events and changes in proteinuria<br>Measure:number of cardiovascular events and changes in proteinuria<br>Timepoints:During treatment<br>;<br>Outcome name:quality of life and healthcare resource utilization<br>Measure:quality of life and healthcare resource utilization<br>Timepoints:At the end of the study<br>