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

NCT01167881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1549

Last updated 2016-09-02

Study results available
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Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 10773

Medium dose once daily

DRUG

Glimepiride

1-4 mg once daily

DRUG

Placebo

Placebo matching BI 10773

DRUG

Placebo

Placebo matching Glimepiride

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
2010-08-31
Primary Completion
2013-08-31
Completion
2015-08-31

Countries

  • United States
  • Argentina
  • Austria
  • Canada
  • Colombia
  • Czechia
  • Finland
  • Hong Kong
  • India
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Philippines
  • Portugal
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • 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 NCT01167881 on ClinicalTrials.gov