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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus and Heart Failure

Treatments: Drug: Empagliflozin; Drug: Placebo; Drug: LIK066

Study type: Interventional

Funder types: Industry

Identifiers

NCT03152552

CLIK066B2204

2016-003084-19 (EudraCT Number)

Details and patient eligibility

About

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

Full description

The study was prematurely discontinued on 04-May-2018 due to slow enrollment that would preclude obtaining study results in a timely manner.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 5 patient groups, including a placebo group

LIK066 2.5mg

Experimental group

Description:

Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks.

Treatment:

Drug: LIK066

LIK066 10mg

Experimental group

Description:

Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks.

Treatment:

Drug: LIK066

LIK066 50mg

Experimental group

Description:

Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks.

Treatment:

Drug: LIK066

Empagliflozin

Active Comparator group

Description:

Participants randomized to this treatment arm received empagliflozin once daily for 36 weeks.

Treatment:

Drug: Empagliflozin

Placebo

Placebo Comparator group

Description:

Participants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo.

Treatment:

Drug: Placebo