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Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

NCT01159600 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1504

Last updated 2014-06-17

Study results available
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Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo identical to BI 10773 high dose

Placebo tablets matching BI 10773 high dose

DRUG

Placebo identical to BI 10773 low dose

Placebo tablets matching BI 10773 low dose

DRUG

BI 10773

BI 10773 tablets once daily high dose open label

DRUG

BI 10773

BI 10773 tablets once daily high dose

DRUG

Placebo identical to BI 10773 low dose

Placebo tablets matching BI 10773 low dose

DRUG

BI 10773

BI 10773 tablets once daily low dose

DRUG

Placebo identical to BI 10773 high dose

Placebo tablets matching 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
2012-02-29

Countries

  • United States
  • Canada
  • China
  • France
  • Germany
  • India
  • Mexico
  • Slovakia
  • Slovenia
  • South Korea
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

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 NCT01159600 on ClinicalTrials.gov