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

• Status: Completed
• Trial end date: 2018-01-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin

Criteria

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