12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

NCT00789035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2014-06-18

Study results available
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Summary

The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 10773

DRUG

placebo

DRUG

metformin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-10-31

Countries

  • Argentina
  • Croatia
  • Estonia
  • Germany
  • Italy
  • Lithuania
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Sweden
  • Taiwan
  • Ukraine

Study Locations

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Entities

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 NCT00789035 on ClinicalTrials.gov