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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: empagliflozin 10 mg<br> | Drug: Empagliflozin<br> <br> Drug: Placebo<br>* For blinding purposes<br>|
| Experimental: empagliflozin 25 mg<br> | Drug: Empagliflozin<br> <br> Drug: Placebo<br>* For blinding purposes<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br> <br> Drug: Placebo<br>* For blinding purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. | The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment. The term baseline refers to the last observation prior to the administration of any randomised study drug. Means presented are the adjusted means. | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs) | Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented | From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks |