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Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

NCT01734785 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2024-09-19

Study results available
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Summary

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Linagliptin

tablet

DRUG

Empagliflozin + Linagliptin

Fixed dose combination.

DRUG

Empagliflozin + Linagliptin

Fixed dose combination

DRUG

Empagliflozin + Linagliptin

Fixed dose combination

DRUG

Empagliflozin placebo + Linagliptin placebo

Matching Empagliflozin + Linagliptin low dose

DRUG

Empagliflozin + Linagliptin

Fixed dose combination.

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-08
Primary Completion
2015-03-23
Completion
2015-03-23

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • El Salvador
  • France
  • New Zealand
  • Norway
  • South Korea
  • Spain
  • Taiwan

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 NCT01734785 on ClinicalTrials.gov