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

NCT01164501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 741

Last updated 2014-06-16

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Canada
  • France
  • Hong Kong
  • India
  • Malaysia
  • Netherlands
  • Philippines
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01164501 on ClinicalTrials.gov