A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin

Inclusion Criteria:

• Age ≥18 years and ≤75 years old at Visit 1;
• Chinese patient with diagnosis of Type 2 diabetes prior to Visit 1;
• A stable treatment with premixed Insulin (≥ 20IU/day) or basal insulin (≥ 16 IU/day)for at least 12 weeks prior to enrolment with or without up to two OADs
• With maximum insulin dose of ≤ 1 unit/kg/day. Acceptable basal insulins shouldhave duration of action up to 24 h such as insulin Degludec, insulin glargin,insulin detemir or NPH (neutral protamine hagedorn) insulin; Acceptable pre-mixedinsulins could be once or twice daily posology only. The total insulin doseshould not be changed by more than 20% of the baseline value within the 12 weeksprior to randomisation (Visit 3). Both human insulin & insulin analogue areacceptable;
• If the patient is taking OADs, regimen has to be unchanged for at least 12 weeksprior to randomization (Visit 3);
• If the patient is taking metformin, stable dose (at least 1500 mg daily ormaximum tolerated dose) must be maintained for at least 12 weeks without doseadjustments prior to randomization (Visit 3);
• HbA1c ≥7.5% and ≤11.0% at Visit 1;
• Fasting C-peptide: >0.5 ng/mL (>166pmol/L) at Visit 1；
• 18.5 kg/m2 ≤ BMI ≤ 45 kg/m2 at Visit 1;
• Signed and dated written informed consent in accordance with ICH-GCP and locallegislation prior to admission to the trial;
• Male or female patients. Women of childbearing potential (WOCBP) must be ready andable to use highly effective methods of birth control per ICH M3 (R2) that result in alow failure rate of less than 1% per year when used consistently and correctly. A listof contraception methods meeting these criteria is provided in the patientinformation.

Exclusion Criteria:

• Diagnosis of Type 1 diabetes;
• Patients receiving MDI insulin or insulin pump treatment;
• eGFR <45ml/min/1.73m2 calculated based on MDRD formula;
• Uncontrolled hyperglycemia [glucose level >13. 9 mmol/l after an overnight fast duringplacebo run-in];
• Severe hypoglycemia episode (event requiring the assistance of another person toactively administer carbohydrate, glucagon or other resuscitative actions) within 6months prior to Visit 1;
• History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. Myocardialinfarction, stroke or transient ischaemic attack within 3 months prior to Visit 1;
• Bariatric surgery;
• Further criteria apply