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Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

NCT01368081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1162

Last updated 2014-06-17

Study results available
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Summary

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Metformin

Metformin tablets 500-2250 mg a day (twice or three times per day)

DRUG

BI 10773

BI 10773 low dose tablet once daily

DRUG

Placebo (low dose)

Placebo tablets once daily

DRUG

BI 10773

BI 10773 high dose tablet once daily

DRUG

Placebo (high dose)

Placebo tablets once daily

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Japan

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 NCT01368081 on ClinicalTrials.gov