MedTrace Logo

Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

NCT01011868 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2014-09-30

Study results available
· View outcomes & findings →

Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 10773 placebo

BI 10773 placebo

DRUG

BI 10773 low dose

BI 10773 low dose

DRUG

BI 10773 high dose

BI 10773 high dose

DRUG

BI 10773 placebo

BI 10773 placebo

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
2009-11-30
Primary Completion
2012-05-31

Countries

  • United States
  • Denmark
  • France
  • Ireland
  • Portugal
  • South Korea
  • United Kingdom

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 NCT01011868 on ClinicalTrials.gov