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Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

NCT00798161 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 857

Last updated 2014-01-28

Study results available
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Summary

The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 1356

BI 1356 high dose tablet, once daily

DRUG

BI 1356 + metformin

BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily

DRUG

Bi 1356 + metformin

BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily

DRUG

Metformin

Metformin 500 mg tablet, twice daily

DRUG

metformin

metformin 1000 mg tablet, twice daily

DRUG

matching placebo

matching placebo

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
2008-12-31
Primary Completion
2010-05-31

Countries

  • Canada
  • Croatia
  • Estonia
  • France
  • Germany
  • India
  • Lithuania
  • Mexico
  • Netherlands
  • Romania
  • Russia
  • Sweden
  • Tunisia
  • 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 NCT00798161 on ClinicalTrials.gov