patients with type 2 diabetic nephropathy independent of blood pressure
lowering n Irbesartan would be superior to placebo. (primary comparison) n
Irbesartan ...
IDNT Irbesartan Diabetic Nephropathy Trial Melisa Cooper, M.D., M.S. Vice President, Pharmaceutical Research Institute Bristol-Myers Squibb
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IDNT Hypotheses Interruption of the renin-angiotensin system with irbesartan has renoprotective effects in patients with type 2 diabetic nephropathy independent of blood pressure lowering n Irbesartan would be superior to placebo
(primary comparison) n Irbesartan would be superior to amlodipine
(secondary comparison) C-2 C-2
IDNT: Primary Endpoint
Time to a composite of: n Doubling of baseline serum creatinine n End-stage renal disease (defined as renal
transplantation, need for dialysis, or serum creatinine ≥ 6.0 mg/dL) n Death (all cause mortality)
C-3 C-3
IDNT: Secondary Endpoint Time to a composite of: n Cardiovascular death n Non-fatal myocardial infarction n Hospitalization for heart failure n Permanent neurological deficit attributed
to stroke n Above-the-ankle amputation C-4 C-4
IDNT Major Study Entry Criteria n Age 30 to 70 years n Type 2 diabetes n SeSBP > 135 mmHg and/or SeDBP > 85 mmHg,
or receiving antihypertensive medication n 24-hour urine protein excretion ≥ 900 mg n Serum creatinine level 1.0 - 3.0 mg/dL in women;
1.2 - 3.0 mg/dL in men n No known non-diabetic renal disease n No recent cardiovascular events n Serum potassium inside of normal range n BMI < 45 kg/m2
C-5 C-5
IDNT Study Design
Screening and Enrollment
Titration
Double-blind Treatment* Placebo
N = 569
Irbesartan 300 mg N = 579 Amlodipine 10 mg N = 567 Up to 5 weeks