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Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

NCT00881530 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2014-06-16

Study results available
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Summary

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 10773

BI 10773 high dose once daily

DRUG

Metformin

open label comparator

DRUG

BI 10773

BI 10773 low dose once daily

DRUG

Sitagliptin

open label comparator

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-05-31

Countries

  • United States
  • Austria
  • Croatia
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • 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 NCT00881530 on ClinicalTrials.gov