Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

Inclusion criteria:

- Male or female patient receiving insulin for the treatment of documented diagnosis of
Type 1 Diabetes Mellitus (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:

- Multiple Daily Injections (MDI) of insulin consisting of at least one basal
insulin injection and at least three daily bolus injections OR

- Continuous Subcutaneous Insulin Infusion (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

Exclusion criteria:

- History of Type 2 Diabetes Mellitus (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, Glucagon-like-peptide 1 (GLP-1) analogues,
Sodium-Glucose Co-Transporter (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/unconsciousness and/or seizure that
required hospitalisation or hypoglycaemia-related treatment by an emergency physician
or paramedic within 3 months prior to Visit 1 and until randomisation

- Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until
randomisation

Additional exclusion criteria may apply