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

Conditions

• Diabetes Mellitus and Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LIK066 — DRUG
  LIK066 was supplied in different doses as tablets taken orally.
• Placebo — DRUG
  Placebo was supplied as tablets and capsules taken orally.
• Empagliflozin — DRUG
  Empagliflozin was supplied as capsules taken orally.

Study Details

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

Key Dates

Start date

Jul 25, 2017

Status verified

Aug 2019

Primary completion

Jun 6, 2018

Completion

Jun 6, 2018

Study Design

Enrollment

125 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LIK066 2.5mg
  Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks.
• Experimental: LIK066 10mg
  Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks.
• Experimental: LIK066 50mg
  Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks.
• Active Comparator: Empagliflozin
  Participants randomized to this treatment arm received empagliflozin once daily for 36 weeks.
• Placebo Comparator: Placebo
  Participants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo.

Primary Outcome Measure

Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (21)

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