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 26 weeks in patients with Type 1 Diabetes Mellitus (EASE-3) - EASE-3

Boehringer Ingelheim Finland Ky0 个研究点目标入组 1,920 人开始时间: 2015年9月1日最近更新: 2017年12月11日

适应症

试验速览

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•-Signed and dated written informed consent
•-Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) > 1 year
•-C-peptide value of < 0.7 ng/mL
•-Use of Multiple Daily Injections (MDI) of insulin or insulin pump user with total daily insulin >= 0.3 and <= 1.5 U/kg
•-Glycated haemoglobin (HbA1c) >= 7.5% and <= 10.0%
•-Good understanding of T1DM
•-Age >= 18 years
•-Body Mass Index (BMI) >= 18.5 kg/m2
•-Estimated glomerular filtration rate >= 30 mL/min/1.73 m2
•-Women of child-bearing potential must use highly effective methods of birth control
•-Compliance with trial medication administration between 80% and 120% during placebo run-in period
•Further inclusion criteria 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 860
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•-History of type 2 diabetes mellitus, 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 except subcutaneous basal and bolus insulin within last 3 months
•-Occurrence of severe hypoglycaemia within last 3 months and until randomisation
•-Occurence of diabetic ketoacidosis within 3 months prior to Visit 1 and until Visit 6
•-Irregular sleep/wake cycle
•-Acute coronary syndrome, stroke or TIA within last 3 months
•-Severe gastroparesis
•-Brittle diabetes
•-Liver disease
•-Eating disorders
•-Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen
•-Treatment with systemic corticosteroids
•-Change in dose of thyroid hormones within last 6 weeks and until randomisation
•-Cancer or treatment for cancer in the last five years
•-Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
•-Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
•-Alcohol or drug abuse
•-Intake of an investigational drug in another trial within last 30 days
•Further exclusion criteria apply

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