Back to resultsA Research Study to Evaluate the Renal (Kidney) Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes (0954-147)(COMPLETED)
Primary Purpose
Type 2 Diabetes, Nephropathy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0954, losartan / Duration of Treatment: mean 3.4 years
Placebo / Duration of Treatment: mean 3.4 years
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Combined endpoint of doubling of serum creatinine, ESRD or death.
Secondary Outcome Measures
Secondary parameters: number of cardiovascular events and changes in proteinuria. Tertiary parameters: quality of life and healthcare resource utilization.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00308347
Brief Title
A Research Study to Evaluate the Renal (Kidney) Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes (0954-147)(COMPLETED)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 1996 (undefined)
Primary Completion Date
February 2001 (Actual)
Study Completion Date
April 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1513 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0954, losartan / Duration of Treatment: mean 3.4 years
Intervention Type
Drug
Intervention Name(s)
Placebo / Duration of Treatment: mean 3.4 years
Primary Outcome Measure Information:
Title
Combined endpoint of doubling of serum creatinine, ESRD or death.
Secondary Outcome Measure Information:
Title
Secondary parameters: number of cardiovascular events and changes in proteinuria. Tertiary parameters: quality of life and healthcare resource utilization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16187699
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
15579515
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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A Research Study to Evaluate the Renal (Kidney) Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes (0954-147)(COMPLETED)
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