2023-503760-17-00已完成2 期
Effects of empagliflozin on plasma glucose in patients with HNF1A-MODY: a randomized, double-blind, crossover trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Mean difference between empagliflozin and placebo in mean sensor glucose measured by continous glucose monitoring (CGM) during the last 10 or 14 (depending on CGM device) days of each treatment period evaluated in principal stratum.
研究概览
简要总结
To investigate the glucose-lowering effect of empagliflozin 25 mg once-daily in patients with HNF1A-MODY.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Mean difference between empagliflozin and placebo in mean sensor glucose measured by continous glucose monitoring (CGM) during the last 10 or 14 (depending on CGM device) days of each treatment period evaluated in principal stratum.
Mean difference between empagliflozin and placebo in mean sensor glucose measured by continous glucose monitoring (CGM) during the last 10 or 14 (depending on CGM device) days of each treatment period evaluated in principal stratum.
次要结局
- CGM: Coefficient of variation (CV%)
- CGM: standard deviation
- CGM: percentage of time in range (3.9–10 mmol/L)
- CGM: percentage of time above range (>10 mmol/L)
- CGM: percentage of time below <3.9 mmol/L
- CGM: percentage of time below <3.0 mmol/L
- Serum (or plasma) fructosamine
- Serum (or plasma) glycated albumin
- 24h urinary glucose excretion (24h UGE)
- 24h renal threshold of glucose excretion (estimated using CGM and 24h UGE)
- Fasting urinary glucose-to-creatine-ratio
- Fasting ketone level (self-measured, before clinical visits)
- Fasting capillary blood glucose (self-measured, before clinical visits)
- Body weight
- Number of hypoglycaemic events and participants with events measured by CGM stratified by severity (level 1, 2, and 3)
- Number of hypoglycaemic events reported by participants stratified by severity (level 1, 2, and 3)
- Number of participants with fasting ketone levels ≥0.6 mmol/l
- Number of participants with fasting ketone levels ≥1.5 mmol/l
研究者
Tina Vilsbøll
Scientific
Steno Diabetes Center Copenhagen
研究点 (2)
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