Randomized double-blind placebo-controlled study assessing efficacy and safety of luseogliflozin on the top of metformin in Caucasian patients with type 2 diabetes mellitus and inadequate glycemic control

JSC Servier (Russia)0 sites328 target enrollmentApril 14, 2022

Overview

2023 Results article in https://doi.org/10.1136/bmjdrc-2022-003290 (added 19/06/2023)

Registry

who.int

Start Date

April 14, 2022

End Date

August 19, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

JSC Servier (Russia)

•1\. Age between 18 and 75 years both inclusive
•2\. Caucasian race
•3\. Outpatients with type 2 diabetes mellitus diagnosed for not less than 3 months prior to selection
•4\. Ongoing monotherapy with metformin \=1500 mg daily in the stable dose for at least 3 months
•5\. Inadequate control of diabetes mellitus as confirmed by HbA1c \=7\.5% and \=10% according to the previous laboratory result not more than 3 months ago
•6\. BMI less than 36 kg/m²
•7\. Antihypertensive drugs, beta\-blockers, diuretics, drugs for treatment of dyslipidaemia, if administered, should be in a stable dose for at least 6 weeks prior to selection and planned to be continued during the study
•8\. Signed informed consent before any study investigations. A specific written consent form is to be signed by the patients participating in PK/PD assessment
•9\. HbA1c 7\.5%–10\.0% (inclusive) at central laboratory measured in selection period and assessed at inclusion visit
•10\. The lab results, taken in the selection period, are available and free from any abnormalities likely to interfere with the study conduct or evaluation

•1\. Patients who are in an insulin\-dependent state (who regularly need to use an insulin preparation)
•2\. Patients with diabetes mellitus other than type 2 (type 1 diabetes mellitus, diabetes mellitus due to some specific mechanism condition other than type 1 or 2, gestational diabetes mellitus)
•3\. Unstable diabetes mellitus (documented severe hypoglycemia or hospitalization due to diabetes decompensation or due to hypoglycemia within 1 year prior to selection)
•4\. Current or previous treatment with 2 or more antidiabetic drugs, except if they were prescribed due to decompensation due to acute illness or surgery and not less than 3 months ago
•5\. Patient with any uncontrolled endocrine disease other than diabetes mellitus
•6\. Patients with any of the following renal conditions:
•6\.1\. Known estimated glomerular filtration rate (eGFR) of \<45 ml/min/1\.73m²
•6\.2\. Stage 3 (overt nephropathy) or worse diabetic nephropathy
•6\.3\. History of nephrectomy or renal transplantation
•6\.4\. History of dialysis within 1 year prior to selection.