Effects of empagliflozin on plasma glucose in patients with HNF1A-MODY: a randomized, double-blind, crossover trial

Steno Diabetes Center Copenhagen0 个研究点目标入组 24 人开始时间: 2023年3月27日最近更新: 2024年8月21日

适应症

试验速览

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•Informed consent, Diabetes caused by a heterozygous mutation (pathogenic or likely pathogenic according to ACMG criteria) in the HNF1A-gene, Age =18 years, Hemoglobin A1c =48 mmol/mol, Stable glucose-lowering treatment for 60 days prior to screening visit, Treatment with at least one glucose-lowering drug (in a fixed dose)

•Breast feeding, pregnancy or intention to become pregnant, Any concomitant disease or other condition(s) judged by investigators to be a safety concern or otherwise problematic for the conduct of the trial, Inability to complete the study, Not using adequate contraceptive methods if woman of child-bearing potential (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections)), History of acute and/or chronic pancreatitis, Liver disease and/or alanine transaminase (ALT) and/or aspartate transaminase (AST) >2x upper normal serum levels, Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2, Anaemia (males blood haemoglobin <8.0 mmol/l and females <7.0 mmol/l), Known allergic reaction to study drug (empagliflozin), Treatment with an SGLT2-inhibitor within the last 60 days prior to screening visit, Inability (judged by investigator) or unwillingness (of the potential participant) to abstain from a variable dosing regimen of glucose-lowering drugs (i.e., SU, repaglinide or insulin (bolus insulin) in a self-titrated regimen) during the study.

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