6/29/23, 1:12 AM ROADMAP Pathway Feedback Search Clinical Topics Home Studies ROADMAP ROADMAP Disease Diabetes mellitus type 2 Trial question What is the role of olmesartan in preventing the occurrence of microalbuminuria in patients with T2DM? Study design Multi-center Double blinded RCT Population Characteristics of study participants 54.0% female N = 4447 46.0% male 4447 patients (2395 female, 2052 male) Inclusion criteria: adult patients with T2DM Key exclusion criteria: CrCl <30 mL/min; severe uncontrolled hypertension; renal or renal-vascular disease; treatment with ARB or ACE inhibitors within 6 month prior to screening Interventions N=2232 olmesartan (a dose of 40 mg once daily) N=2215 placebo (matching placebo tablets) Primary outcome Time to first onset of microalbuminuria https://web.pathway.md/studies/recC5DUKW56gjkHeT 1/2 6/29/23, 1:12 AM ROADMAP Pathway 722.0 days 722 576 541.5 days 361.0 days 180.5 days Significant increase 0.0 days Olmesartan Placebo Significant increase in time to the first onset of microalbuminuria (722 days vs. 576 days; HR 1.3, 95% CI 1.06 to 1.59) Secondary outcomes No significant difference in composite of cardiovascular complications or death from cardiovascular causes (4.3% vs. 4.2%; HR 1, 95% CI 0.75 to 1.33) Significant increase in decline in eGFR (4.9 vs. 1; MD 3.9, 95% CI 1.59 to 6.21) Significant increase in death from cardiovascular causes (0.7% vs. 0.1%; HR 4.94, 95% CI 1.43 to 17.06) Safety outcomes No significant differences in serious adverse events, renal events. Significant difference in drug-related adverse events (11.4% vs. 7.5%). Conclusion In adult patients with T2DM, olmesartan was superior to placebo with respect to time to the first onset of microalbuminuria. Reference Hermann Haller, Sadayoshi Ito, Joseph L Izzo Jr et al. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. Open reference URL https://web.pathway.md/studies/recC5DUKW56gjkHeT 2/2