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Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

NCT01210001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2014-06-17

Study results available
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Summary

This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Placebo tablets matching BI 10773 low dose

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

Placebo

Placebo tablets matching BI 10773 high dose

DRUG

Placebo

Placebo tablets matching BI 10773 high dose

DRUG

Placebo

Placebo tablets matching BI 10773 high dose

DRUG

BI 10773

BI 10773 tablets once daily

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
2010-09-30
Primary Completion
2012-04-30

Countries

  • United States
  • Canada
  • Greece
  • India
  • Philippines
  • Thailand
  • Ukraine

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 NCT01210001 on ClinicalTrials.gov