Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

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