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Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

NCT01306214 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2014-06-17

Study results available
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Summary

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Conditions

  • Diabetes Mellitus, Type 2
  • Obesity

Interventions

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

BI 10773

BI 10773 low dose once daily

DRUG

BI 10773

BI 10773 high dose once daily

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
2011-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • Belgium
  • Bulgaria
  • Colombia
  • Czechia
  • Finland
  • France
  • Germany
  • Guatemala
  • Mexico
  • Peru
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01306214 on ClinicalTrials.gov