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Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients

NCT01708902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 876

Last updated 2015-04-24

Study results available
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Summary

Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

linagliptin2.5mg/metformin1000mg

linagliptin2.5mg/metformin1000mg BID

DRUG

linagliptin2.5mg/metformin1000mg

linagliptin2.5mg/metformin1000mg BID

DRUG

linagliptin 5mg

linagliptin 5mg once daily

DRUG

Metformin 500mg

Metformin 500mg BID

DRUG

linagliptin2.5mg/metformin500mg

linagliptin2.5mg/metformin500mg BID

DRUG

linagliptin2.5mg/metformin500mg

linagliptin2.5mg/metformin500mg BID

DRUG

linagliptin 5mg

linagliptin 5mg once daily

DRUG

Metformin 1000mg

Metformin 1000mg BID

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • China
  • Malaysia
  • Philippines
  • Vietnam

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 NCT01708902 on ClinicalTrials.gov