TerminatedPhase 2

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

Stopped: This study terminated prematurely because of slow enrollment

United States, Argentina, Austria125 participantsStarted 2017-07-25

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key 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) Key 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT03152552

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06-06

Results submitted2019-04-11

View on ClinicalTrials.gov More Diabetes Mellitus and Heart Failure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.