Clinical Trial Details

NCT ID: NCT03152552
Date Last Changed: October 17, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Diabetes Type 2 With Heart Failure

Research Study Title

A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Assess the Effect of 3 Doses of LIK066 Compared to Placebo or Empagliflozin in Type 2 Diabetes Mellitus Patients With Heart Failure

Purpose

This is 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

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Novartis Pharmaceuticals
Duration
16 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • BMI ≥ 22kg/m^2

  • Type 2 diabetes with HbA1c between 6.5% and 10.0%

  • Documented symptomatic chronic heart failure (NYHA II-IV)

  • Plasma NT-proBNP > 300pg/ml

  • eGFR ≥ 45ml/min/1.73m^2 (calculated by MDRD)

Exclusion Criteria:

  • Pregnant or nursing (lactating) women

  • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes

  • History of ketoacidosis, lactic acidosis, or hyperosmolar coma

  • Symptomatic genital infection or UTI within 4 weeks of screening

  • Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization

  • Unstable angina within 3 months of screening

  • Isolated right HF due to pulmonary disease

  • Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization

  • History of lower limb amputation

  • Diabetic foot ulcer at screening

Site Locations (29)

Country State City Zip Facility and Contact
United States Alabama Huntsville 35801 Novartis Investigative Site
United States California Carmichael 95608 Novartis Investigative Site
United States California Concord 94520 Novartis Investigative Site
United States California Long Beach 90813 Novartis Investigative Site
United States California Northridge 91325 Novartis Investigative Site
United States Florida Bradenton 34209 Novartis Investigative Site
United States Florida Clearwater 33756 Novartis Investigative Site
United States Missouri Saint Louis 63128 Novartis Investigative Site
United States Nebraska Omaha 68114 Novartis Investigative Site
United States South Carolina Charleston 29407 Novartis Investigative Site
United States Texas San Antonio 78229 Novartis Investigative Site
United States Washington Tacoma 98405 Novartis Investigative Site
Canada Ontario London N6A 5A5 Novartis Investigative Site
Canada Quebec Sainte-Foy G1V 4G5 Novartis Investigative Site
Canada Quebec G1V 4G2 Novartis Investigative Site
Czechia Czech Republic Brandys nad Labem 250 01 Novartis Investigative Site
Czechia Karvina 73506 Novartis Investigative Site
Czechia Prague 5 158 00 Novartis Investigative Site
Czechia Prerov 751 52 Novartis Investigative Site
Denmark Hellerup 2900 Novartis Investigative Site
Denmark Svendborg 5700 Novartis Investigative Site
Germany Berlin 10789 Novartis Investigative Site
Germany Fulda 36037 Novartis Investigative Site
Germany Leipzig 04103 Novartis Investigative Site
Hungary Budapest 1134 Novartis Investigative Site
Hungary Szeged 6720 Novartis Investigative Site
Hungary Szekszard 7100 Novartis Investigative Site
Singapore Singapore 169609 Novartis Investigative Site
Taiwan Taichung 40447 Novartis Investigative Site

Contact

Novartis Pharmaceuticals
1-888-669-6682
E-mail:

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