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

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Empagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02589639

1245.107

Details and patient eligibility

About

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

Enrollment: 269 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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269 participants in 3 patient groups, including a placebo group

empagliflozin 10 mg

Experimental group

Treatment:

Drug: Empagliflozin

Drug: Placebo

Drug: Placebo

empagliflozin 25 mg

Experimental group

Treatment:

Drug: Empagliflozin

Drug: Placebo

Drug: Placebo

placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo