NCT01164501

Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 741 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.

Conditions

• Diabetes Mellitus, Type 2
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	BI 10773	BI 10773 tablets once daily
DRUG	Placebo	Placebo tablets identical to BI 10773 low dose
DRUG	Placebo	Placebo tablets identical to BI 10773 high dose
DRUG	BI 10773	BI 10773 tablets once daily
DRUG	Placebo	Placebo tablets identical to BI 10773 low dose
DRUG	Placebo	Placebo tablets identical to BI 10773 high dose

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-07-16
• Last updated: 2014-06-16
• Results posted: 2014-06-16

Locations

127 sites across 15 countries: United States, Canada, France, Hong Kong, India, Malaysia, Netherlands, Philippines, Poland, Portugal, Russia, Slovakia, South Africa, Spain, United Kingdom