Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

A 52-week Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Empagliflozin Once Daily, as an add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

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

Inclusion criteria:

• Diagnosis of type 2 diabetes mellitus
• Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening
• Fasting C-peptide must be > 0.5 ng/mL
• HbA1c at screening in Patients who are treated with insulin alone must be >=7.5% and <=10.0%
• HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD) must be >=7.0% and <=9.5% at screening, and >=7.5% and <=10.0% at placebo run-in period
• Age at informed consent must be >=20 and <75 years
• BMI at screening must be >22 and <=40 kg/m2
• Further inclusion criteria apply

Exclusion criteria:

• Patients who experience uncontrolled hyperglycaemia before randomization
• Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor
• Patients with recent cardiovascular and/or stroke events
• Patients with hepatic and/or renal dysfunction
• Patients who received anti-obesity drugs or other treatment leading to unstable body weight
• Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin
• Pre-menopausal women who are nursing or pregnant
• Further exclusion criteria apply