This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

Inclusion criteria:

• Diagnosis of type 2 diabetes mellitus
• Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be >=7.0% and <=10.0% at screening
• Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be >=7.0% and <=9.0% at screening and >=7.0% and <=10.0% at placebo run-in
• Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be >=7.0% and <=10.0% at both screening and placebo run-in
• Age at informed consent must be >=20 years
• BMI at screening must be <=40 kg/m2
• Further inclusion criteria apply

Exclusion criteria:

• Uncontrolled hyperglycaemia with a glucose values >270 mg/dL (>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement
• Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.
• Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent
• Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period
• Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period
• Further exclusion criteria apply

Full analysis set:

The full analysis set (FAS) consisted of all patients in the treated set (TS) who were treated with at least 1 dose of the randomised study drug and had a baseline HbA1c assessment. The assignment of patients to treatment groups was based on the randomised study drug at time of randomisation.

All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks