LIK066 in Type 2 Diabetes Mellitus Patients with Heart Failure
Research type
Research Study
Full 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
IRAS ID
218604
Contact name
Hoong sern Lim
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-003084-19
Duration of Study in the UK
1 years, 6 months, days
Research summary
Type 2 diabetes (T2DM) is a serious condition associated with high risk of cardio-vascular disease (CVD), and its complications, such as heart failure (HF). In patients with T2DM, both the incidence rate of HF and hospitalizations/mortality are higher than in patients without diabetes
Sodium-glucose co-transporter (SGLT) 2 inhibitors are approved for the treatment of type 2 diabetes. In addition, long-term treatment with the SGLT2 inhibitor empagliflozin in a study resulted in 14% relative reduction (RR) in major adverse cardiovascular events against placebo.
LIK066 is an inhibitor of SGLT1 and SGLT2. Via inhibition of both SGLT1 and SGLT2 in the proximal renal tubule, the drug may further enhance the effects on renal sodium and glucose handling compared with the selective SGLT2 inhibitors.
SGLT1 receptors are also expressed in the heart, however their role is not fully understood. The current study is planned to explore the effect of the dual SGLT1/2 inhibitor LIK066 on the HF biomarker NT-proBNP in a T2DM population with compromised cardiac function, along with exploration of its glucose-lowering potential.
The purpose of the study is to evaluate the efficacy, safety and tolerability of LIK066 in T2DM patients with cardiac disease and HF to help inform decisions on further development of LIK066.
The study design is a multi-centre, randomised, double-blind, double-dummy, parallel-group dose-finding study to assess efficacy, tolerability and safety of LIK066 versus placebo or empagliflozin. Following a screening visit, eligible subjects will enter the run-in. After the run-in period, eligible subjects will be randomized and treated for 36 weeks. The total duration of the study is up to 40 weeks
There will be approximately 6 sites in the UK with a plan to recruit a total of 24 patients.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0281
Date of REC Opinion
13 Jul 2017
REC opinion
Further Information Favourable Opinion