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A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

NCT00740051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2014-06-27

Study results available
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Summary

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Linagliptin

5mg once daily

DRUG

Linagliptin Placebo

0 mg placebo comparator for part 1 of study (to 18 weeks)

DRUG

Glimepiride

1-4mg for part 2 of study (weeks 19-52)

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
2008-08-31
Primary Completion
2010-08-31

Countries

  • United States
  • Canada
  • Mexico
  • Philippines
  • Romania
  • Russia
  • Ukraine

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 NCT00740051 on ClinicalTrials.gov