EUCTR2014-001922-14-GB进行中（未招募）1 期
A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 52 weeks in patients with Type 1 diabetes mellitus (EASE-2) - EASE-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Signed and dated written informed consent by the date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
- •2. Male or female patient receiving insulin for the treatment of documented diagnosis of T1DM for at least 1 year at the time of Visit 1
- •3. Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
- •4. Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:
- •- MDI of insulin consisting of at least one basal insulin injection and at least three daily
- •bolus injections OR
- •- CSII of any insulin type, with at least 5 months experience of using CSII prior to Visit 1
- •For both MDI and CSII, the total daily insulin dose must be = 0.3 U/kg and = 1.5 U/kg at Visit 1
- •5. HbA1c = 7.5% and = 10.0% at Visit 5 measured by the central laboratory, and provided that the patient's HbA1c does not increase by > 0.5% between Visit 1 and Visit 5
- •6. Based on the Investigator's judgement patient must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed at Visits 1-5 and just before randomisation):
- •- patient-led management and adjustment of insulin therapy
- •- reliable approach to insulin dose adjustment for meals, such as carbohydrate counting
- •- reliable and regular home-based blood glucose monitoring
- •- recognise the symptoms of DKA, and reliably monitor for ketones
- •- implementation of an established sick day management regimen
- •7. Age = 18 years at Visit 1
- •8. Body Mass Index (BMI) of = 18.5 kg/m2 at Visit 1
- •9. eGFR = 30 mL/min/1.73 m² as calculated by the CKD-EPI formula, based on creatinine measured by the central laboratory at Visit 1
- •10. Women of child-bearing potential* must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the study and the patient must agree to periodic pregnancy testing during participation in the trial. A list of contraceptive methods meeting these criteria will be provided in the patient information
- •*Women of child-bearing potential are defined as follows:
- •Any female who has experienced menarche and is not post-menopausal (defined as at least 12 months with no menses without an alternative medical cause) or who is not permanently sterilised (e.g. hysterectomy, bilateral oophorectomy or bilateral salpingectomy)
- •11. Compliance with trial medication administration must be between 80% and 120% during the open-label placebo run-in period (see Section 4.1.8.1 for calculation of compliance), to be judged before randomisation
- •Additional inclusion criteria may apply
- •Are the trial subjects under 18? no
排除标准
- •1. History of T2DM, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
- •2. Pancreas, pancreatic islet cells or renal transplant recipient
- •3. T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alphaglucosidase inhibitors, glucagon-like-peptide 1 (GLP-1) analogues, SGLT-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1 or any history of clinically relevant hypersensitivity according to Investigator's judgement
- •4. Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 and until randomisation
- •5. Occurrence of DKA within 3 months prior to Visit 1 and until randomisation
- •6. Irregular sleep/wake cycle (e.g. patients who habitually sleep during the day and work during the night) based on Investigator's judgement
- •7. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischaemic attack (TIA) within 3 months prior to Visit 1
- •8. Diagnosis of severe gastroparesis (based on Investigator's judgement)
- •9. Diagnosis of brittle diabetes based on Investigator judgement
- •10. Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) at Visit 1 or Visit 5 as measured by the central laboratory
- •11. Eating disorders such as bulimia or anorexia nervosa
- •12. Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen leading to unstable body weight (based on Investigator's judgement) 3 months prior to Visit 1 and until randomisation
- •13. Treatment with systemic corticosteroids or planned initiation of such therapy at Visit 1
- •and until randomisation. Inhaled or topical use of corticosteroids (e.g. for asthma/chronic obstructive pulmonary disease) is acceptable
- •14. Change in dose of thyroid hormones within 6 weeks prior to Visit 1 or planned change or
- •initiation of such a therapy at Visit 1 and until randomisation
- •15. Patient is unwilling, based on the Investigator's judgement, to avoid use of paracetamol (acetaminophen) containing drugs throughout the CGM monitoring periods, since this may falsely raise CGM glucose readings
- •16. Medical history of cancer or treatment for cancer in the last five years prior to Visit 1. Resected basal cell carcinoma considered cured is exempted
- •17. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia) at Visit 1
- •18. Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
研究者
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