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Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes

NCT01984606 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-10-27

No results posted yet for this study

Summary

The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Empagliflozin

Empagliflozin once daily

DRUG

Placebo

Placebo matching empagliflozin

DRUG

Sitagliptin

Sitagliptin once daily

DRUG

Placebo

Placebo matching sitagliptin

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
2015-01-31
Primary Completion
2017-02-28
Completion
2017-02-28

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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 NCT01984606 on ClinicalTrials.gov