Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Empagliflozin; Placebo
Intervention description: For blinding purposes
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 977.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3
      doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1
      diabetes mellitus as adjunctive therapy to insulin
    

Eligibility criteria:

        Inclusion criteria:

          -  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

        Exclusion criteria:

          -  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 Transient Ischaemic Attack (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