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Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

NCT00622284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2014-01-29

Study results available
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Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo identical to BI 1356 5mg

Placebo tablet once daily

DRUG

Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg

Placebo tablets once daily

DRUG

BI 1356

5mg, once daily in the morning for 104 weeks

DRUG

Glimepiride

1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-12-31

Countries

  • United States
  • Bulgaria
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • South Africa
  • Sweden
  • United Kingdom

Study Locations

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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 NCT00622284 on ClinicalTrials.gov