NCT00153088

INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

A Randomised, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - Incipient to Overt : Angiotensin 2 Receptor Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION Study -

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 30 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the preventive effect of Telmisartan(Micardis) versus placebo control on the transition to overt nephropathy in patients with diabetic nephropathy manifesting microalbuminuria associated with type II diabetes, and to evaluate the efficacy and safety of Telmisart (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) for diabetic nephropathy patients.

Detailed description

A prospective, randomised, double-blind, multicentric and comparative study to investigate, on a long-term basis, the preventive effect on the transition to overt nephropathy and the safety of Telmisartan (Micardis) against placebo in patients with diabetic nephropathy, manifesting microalbuminuria associated with type II diabetes. Study Hypothesis: The hypothesis is that Telmisartan (Micardis) at 40 mg or 80 mg versus placebo control in patients with concurrent type II diabetic mellitus or diabetic nephropathy demonstrating microalbuminuria, has the preventive effect on transition from incipient to overt nephropathy. Comparison(s): The primary endpoint is defined as the transition from incipient to overt nephropathy, and the non-transition curve will be demonstrated based on the Kaplan-Meier method. The evaluation criteria for the point to transition to overt nephropathy is defined as urinary albumin to creatinine ratios at consecutive 2 measuring points increasing over 300 mg/g-Creatinine and excess 30% increase comparing with the baseline value. The curve of non-transition will be compared with Logrank test. Those in BIBR277 groups are sequentially compared with that in the placebo group by the closed testing procedure.

Conditions

• Diabetic Nephropathies

Interventions

Type	Name	Description
DRUG	Telmisartan capsule 40 mg
DRUG	Placebo
DRUG	Telmisartan capsule 80 mg

Timeline

• Start date: 2003-01-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2005-09-12
• Last updated: 2013-11-01

Locations

160 sites across 1 country: Japan