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Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

NCT00915772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 567

Last updated 2014-05-14

Study results available
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Summary

A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Linagliptin + metformin

Linagliptin tablet low dose + metformin tablet 500 mg bid

DRUG

Linagliptin+metformin

Linagliptin low dose tablet + metformin 1000 mg tablet bid

DRUG

Metformin

Metformin 1000 mg tablet bid

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-06-30

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 NCT00915772 on ClinicalTrials.gov