Phase 3 N=577 Randomized Double-blind Treatment

ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial

Diabetic Nephropathy · Type 2 Diabetes Mellitus · Proteinuria

Bottom Line

View on ClinicalTrials.gov: NCT00141453 ↗

Enrolled (actual)

577

Serious AEs

55.3%

Results posted

May 2011

Primary outcome: Primary: Renal Composite Outcomes — 116; 129 participants — p=0.79

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: olmesartan medoxomil (Drug); Placebo Tablets (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Renal Composite Outcomes	116; 129	0.79
SECONDARY Number of Participants Experiencing Cardiovascular Composite Outcomes	40; 53	0.039 sig
SECONDARY The Change in Proteinuria	-19.5; 12.6; -20.0; 6.9; -24.9; 3.1	—
SECONDARY Reciprocal (1/Serum Creatinine) of Serum Creatinine	-0.071; -0.089	—

Summary

The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.

Eligibility Criteria

Inclusion Criteria

clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis
serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men

Exclusion Criteria

type 1 diabetes
non-diabetic nephropathy
history of myocardial infarction
history of cardiac bypass grafting within 3 months
history of percutaneous coronary intervention (PCI) within 6 months
history of carotid artery or peripheral artery revascularization within 6 months
stroke or transient ischemic attack (TIA) within 1 year
unstable angina pectoris
heart failure of NYHA functional classes III or IV
rapid progression of kidney disease within 3 months
severe orthostatic hypotension
serum potassium level = 5.5 mEq(mmol)L
history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
poor glycemic control: HbA1c level =>11%
history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00141453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.