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A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure

NCT03152552 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2019-08-28

Study results available
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Summary

This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure

Conditions

  • Diabetes Mellitus and Heart Failure

Interventions

DRUG

LIK066

LIK066 was supplied in different doses as tablets taken orally.

DRUG

Placebo

Placebo was supplied as tablets and capsules taken orally.

DRUG

Empagliflozin

Empagliflozin was supplied as capsules taken orally.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2018-06-06
Completion
2018-06-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Puerto Rico
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

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 NCT03152552 on ClinicalTrials.gov