Empagliflozin as adjunctive to insulin therapy over 26 weeks in patients with T1DM (EASE-3)
- Conditions
- Patients with confirmed, insulin-dependent type 1 diabetes mellitus for at least a yearMedDRA version: 20.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-005256-26-PT
- Lead Sponsor
- nilfarma - União Internacional de Lab. Farmacêuticos, Lda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1751
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method