A phase 3, randomised, double-blind, placebo-controlled study assessing the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin. - S005201-175

Institut De Recherches Internationales Servier IRIS0 个研究点目标入组 347 人开始时间: 2024年2月29日最近更新: 2024年8月21日

适应症

试验速览

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•Screening period: Participants with T2D diagnosed > 6 months, aged = 18 years, body mass index (BMI) [25 – 40] kg/m2, Screening period: On stable regimen of diet and exercise and currently treated with: - Either metformin monotherapy at stable daily dose = 1500 mg for at least 12 weeks prior to SCR1 visit and inadequately controlled with HbA1c [8.0%–11.5%] [64-102 mmol/mol] - Or dapagliflozin 10 mg or empagliflozin 10 or 25 mg, in monotherapy or in combination with metformin at daily dose = 1500 mg, daily dose of both treatments must be stable for at least 12 weeks prior to SCR1 visit and inadequately controlled with HbA1c [7.5%-10.5%] [58- 91 mmol/mol]d, For enrolment in the randomised treatment period: HbA1c [7.0% – 10.5%], (53–91 mmol/mol; centralised value collected within the week prior to W000 visit), For enrolment in the randomised treatment period: FPG =15 mmol/L (= 270 mg/dL), (centralised value collected within the week prior to W000 visit), For enrolment in the randomised treatment period: For participant previously treated with metformin monotherapy: participant will be withdrawn if the fasting capillary BG > 15 mmol/L (270 mg/dL; average of 3 fasting SMBG) within the week before SCR3.

•With aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN), bilirubin > 2 times the ULN, estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, haemoglobin < 12 g/dL (males) or < 11g/dL (females)., With contraindication, known or suspected intolerance to gliclazide or dapagliflozin., With uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg and diastolic [DBP] > 100 mmHg)., With recent (in the previous 6 months) major cardiovascular events (myocardial infarction, cardiac surgery/ revascularisation, unstable angina, cerebrovascular accident including transient ischaemic attack (TIA), or stroke)., Treated within 8 weeks prior to the SCR1 visit with sulphonylureas, DPP-4 inhibitors, SGLT2i except dapagliflozin or empagliflozin, GLP-1 receptor agonists, a-glucosidase inhibitors, thiazolidinediones, meglitinides or insulin., Treated within 8 weeks prior to the SCR1 visit with bile acid sequestrants (e.g. colesevelam), dopamine receptor agonists (e.g. bromocriptine), and amylin analogues (e.g. pramlintide)., Chronic (> 10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to the SCR1 visit (intra-basal, intra-articular, intra-ocular, inhaled or topical steroids are permitted).

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