A study to evaluate the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin

Trial details

Who runs it

Institut De Recherches Internationales Servier IRIS

Trial code

EU 2024-511408-18-00

Record updated

2025. október 13.

Original description

To demonstrate the superiority of the free combination of gliclazide MR and dapagliflozin (with or without metformin), in reducing HbA1c after 24 weeks of treatment, compared to placebo and dapagliflozin (with or without metformin) in participants with T2D not optimally controlled with dapagliflozin (with or without metformin).Read full original descriptionShow less

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.

To demonstrate the superiority of the free combination of gliclazide MR and dapagliflozin (with or without metformin), in reducing HbA1c after 24 weeks of treatment, compared to placebo and dapagliflozin (with or without metformin) in participants with T2D not optimally controlled with dapagliflozin (with or without metformin).

Inclusion: 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in the randomised treatment period: For participant previously treated with metformin monotherapy: participant will be withdrawn if the fasting capillary BG 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.

Exclusion: 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, α-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); With uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg and diastolic [DBP] > 100 mmHg); 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.

EU CTIS 2024-511408-18-00