Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus

Inclusion criteria

• Signed and dated written informed consent by the date of Visit 1 (screening) in accordance with Good Clinical Practice (GCP) and local legislation
• Japanese male or female patient receiving insulin for treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) for at least 1 year at the time of Visit 1 (screening).
• Fasting C-peptide value of =0.3 U/kg and 0.5% within 3 months before Visit 1 (screening)
• Based on the investigator's judgment, patient must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed at Visits 1 to 3 and just before randomization)
• patient-led management and adjustment of insulin therapy
• reliable approach to insulin dose adjustment for meals, such as carbohydrate counting
• reliable and regular home-based blood glucose monitoring
• recognize the symptoms of DKA (Diabetic Ketoacidosis), and reliably monitor for ketones
• implementation of an established "sick day" management regimen
• Age >=20 years and =18.5 kg/m2 and =60 mL/min/1.73m² and <=150 mL/min/1.73m² as calculated by Japanese equation based on creatinine measured by the central laboratory at Visit 1 (screening)
• Compliance with trial drug administration must be between 80% and 120% during the placebo run-in period, to be judged at Visit 4 and before randomization

Exclusion criteria

• History of T2DM (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 anti-hyperglycaemic drug (e.g., metformin, alpha-glycosidase inhibitors, glucagon-like-peptide 1 (GLP-1) receptor agonists, SGLT-2 (Sodium-Glucose co-transporter-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins, etc.) within 3 months except subcutaneous basal and bolus insulin before Visit 1 (screening) or any history of clinically relevant hypersensitivity according to the investigator's judgment
• Occurrence of severe hypoglycemia involving coma and/or seizure that required hospitalization or hypoglycemia-related treatment by an emergency physician or paramedic within 3 months before Visit 1 (screening)
• Occurrence of DKA within 3 months before Visit 1 (screening) and until randomization at Visit 4 (Day 1)
• Irregular sleep/wake cycle (e.g., patients who habitually sleep during the day and work during the night) based on the investigator's judgment
• Acute coronary syndrome (non-STEMI, STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months before Visit 1 (screening)
• Diagnosis of severe gastro paresis based on investigator's judgment
• Diagnosis of brittle diabetes based on the investigator's judgment
• Indication of liver impairment, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) at Visit 1 (screening) as measured by the central laboratory
• Eating disorders such as bulimia or anorexia nervosa
• Treatment with anti-obesity drugs (e.g., Mazindol), surgery or aggressive diet regimen leading to unstable body weight (based on the investigator's judgment) 3 months before Visit 1 (screening) and until randomization
• Treatment with systemic corticosteroids or planned initiation of such therapy at Visit 1 (screening). Inhaled use of corticosteroids (e.g., for asthma/chronic obstructive pulmonary disease) is acceptable
• Change in dose of thyroid hormones within 6 weeks before Visit 1 (screening) or planned change or initiation of such a therapy at Visit 1 (screening)
• Medical history of cancer or treatment for cancer in the last 5 years before Visit 1 (screening). Resected basal cell carcinoma considered cured is exempted
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at