2023-509118-12-00招募中2 期
Sotagliflozin for the treatment of post-bariatric hypoglycaemia: The ONSIDE study
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time (% or minutes/per day) in level 2 hypoglycaemia (IG < 3.0 mmol/l) assessed by CGM during the out-patient part (Sotagliflozin 400 mg QD versus placebo)
研究概览
简要总结
We aim to investigate the effect of sotagliflozin on hypoglycaemia and glycaemic excursions in an interventional randomized, double-blind, placebo-controlled crossover study in RYGB-operated persons suffering from confirmed biochemical post-bariatric hypoglycaemia. Participants will undergo the following two interventions in random order for periods of four weeks: sotagliflozin 400 mg QD and placebo.
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
- •Age 18-74 years
- •RYGB-operation conducted >18 months ago
- •History of postprandial neuroglycopenia one–to–three hours after meal intake with subsequent relief after carbohydrate ingestion (per interview)
- •Documented postprandial episodes of level 2 hypoglycaemia (interstitial glucose concentration (IG) <3.0 mmol/l for ≥15 min, ≥2 times/week) assessed by 12-14 days of blinded CGM recording
- •Haemoglobin levels for women >7.3 mmol/l and for men > 8.3 mmol/l
- •Fasting plasma glucose concentration >3.5 mmol/l
- •Sinus rhythm at screening and no medical history of cardiac arrhythmias or cardiac ischaemia
- •Negative urine human chorionic gonadotropin (hCG) (for fertile women)
排除标准
- •Treatment with medication(s) affecting insulin secretion, glucose metabolism, or any antidiabetic drugs
- •History of hypersensitivity or allergic reaction to sotagliflozin or any of the excipients
- •Known or suspected allergies to SGLT-2 inhibitors or related products
- •History of ketoacidosis
- •History of chronic kidney disease or an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2
- •Current participation in another clinical trial with administration of an investigational drug
- •Pregnancy or breastfeeding
- •Glycated haemoglobin (HbA1c) ≥48 mmol/mol
- •Major surgery within 30 days before screening
- •Alcohol abuse (per investigator assessment)
- •Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial
结局指标
主要结局
Time (% or minutes/per day) in level 2 hypoglycaemia (IG < 3.0 mmol/l) assessed by CGM during the out-patient part (Sotagliflozin 400 mg QD versus placebo)
Time (% or minutes/per day) in level 2 hypoglycaemia (IG < 3.0 mmol/l) assessed by CGM during the out-patient part (Sotagliflozin 400 mg QD versus placebo)
次要结局
- Time (% or minutes/per day) in level 1 hypoglycaemia (IG 3.0–3.9 mmol/l) (out-patient part)
- Time (% or minutes/per day) below range (IG < 3.9 mmol/l, including readings <3.0 mmol/l) (out-patient part)
- Time (% or minutes/per day) above tight range (>7.8 mmol/l) (out-patient part)
- Time (% or minutes/per day) in range (IG 3.9–10.0 mmol/l) (out-patient part)
- Time (% or minutes/per day) above range (>10.0 mmol/l) (out-patient part)
- Time (% or minutes/per day) above range (>13.9 mmol/l) (out-patient part)
- Frequency (no of events/day) of hypoglycaemic events (IG < 3.9 mmol/l, ≥15 min) (out-patient part)
- Frequency (no of events/day) of level 1 hypoglycaemic events (IG 3.0–3.9 mmol/l, ≥15 min) (out-patient part)
- Frequency (no of events/day) of level 2 hypoglycaemic events (IG <3.0 mmol/l, ≥15 min) (out-patient part)
- Frequency (no of events/day) of hyperglycaemic events (>10.0 mmol/l, ≥15 min) (out-patient part)
- Glycaemic variability assessed as coefficient of variation (CV) (out-patient part)
- Glycaemic variability assessed as standard deviation (SD) (out-patient part)
- Glycaemic variability assessed as low blood glucose index (LBGI) (out-patient part)
- Change in full score of Edinburgh Hypoglycaemia Symptom scale during treatment (EHSS) (out-patient part)
- Change in full score of fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale (HFS-II) (out-patient part)
- Change in full score of quality of life as assessed by the 36-item Short Form health survey (SF-36) (out-patient part)
- Nadir plasma glucose assessed as the absolute lowest value (in-patient part)
- Time spent in hypoglycaemia (<3.9 mmol/l) (in-patient part)
- Time spent in level 1 and level 2 hypoglycaemia (3.0–3.9 and < 3.0 mmol/l, respectively) (in-patient part)
- Change in full score of Edinburgh Hypoglycemia Symptom scale (in-patient part)
- Glycaemic rescue intervention due to critically low plasma glucose concentration (≤ 1.8 mmol/l) or onset of marked neuroglycopenic symptoms (in-patient part)
- Time spent in hyperglycaemia (>7.8, >10.0 and 13.9 mmol/l, respectively) (in-patient part)
- Peak plasma glucose concentration (in-patient part)
- Changes in plasma / serum concentrations of insulin, C-peptide, glucagon, GLP-1, GIP, epinephrine, norepinephrine, somatotropin, pancreatic polypeptide, and cortisol measured as area under the curve (AUC) and/or incremental (iAUC) as appropriate, peak values and values at nadir plasma glucose concentration (in-patient part)
- Rate of gastric emptying as assessed by acetaminophen concentration (paracetamol): Tmax and Cmax (in-patient part)
研究者
Andreas Andersen
Scientific
Steno Diabetes Center Copenhagen
研究点 (1)
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