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

Boehringer Ingelheim International GmbH0 个研究点目标入组 720 人开始时间: 2015年9月8日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•- 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
•- Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
•- 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
•- HbA1c >/= 7.5% and - Age >/= 18 years at Visit 1
•Additional inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 576
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 144

•- History of T2DM, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
•- Pancreas, pancreatic islet cells or renal transplant recipient
•- T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, 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
•- Occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1
•- Occurence of severe DKA (i.e a pH of <7.0 or prolonged Intensive Care Unit admission exceeding two days) requiring hospitalisation within 3 months prior to Visit 1
•Additional exclusion criteria may apply

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