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BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

NCT00749190 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2014-06-13

Study results available
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Summary

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 10773

DRUG

placebo

DRUG

sitagliptin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-10-31

Countries

  • United States
  • Argentina
  • Austria
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Latvia
  • Norway
  • Romania
  • Russia
  • Slovakia
  • Spain
  • 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 NCT00749190 on ClinicalTrials.gov