Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.

Official Title
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A Randomised, Double-blind, Placebo-controlled, Parallel Group, 4-week Study to Evaluate the Efficacy of Empagliflozin (10 mg and 25 mg Administered Orally Once Daily) in Postprandial Glucose and 24-hour Glucose Variability 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: Placebo
* Drug: Empagliflozin
* Drug: Placebo
* Drug: Placebo
* Drug: Empagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of type 2 diabetes mellitus prior to informed consent Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are: drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or, pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.) Glycosylated haemoglobin (HbA1c) at Visit 1 (screening) for patients without antidiabetic therapy : HbA1c >=7.0 to =<10.0% for patients with one oral antidiabetic drug : HbA1c >=7.0 to =<9.5% Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula) Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin low dose<br>Empagliflozin low dose tablet once daily | Drug: Empagliflozin<br>* Empagliflozin low dose<br>Drug: Placebo<br>* Placebo tablet matching Empagliflozin high dose<br>|
| Experimental: Empagliflozin high dose<br>Empagliflozin high dose tablet once daily | Drug: Placebo<br>* Placebo tablet matching Empagliflozin low dose<br>Drug: Empagliflozin<br>* Empagliflozin high dose tablet once daily<br>|
| Placebo Comparator: Placebo<br>Placebo tablet once daily | Drug: Placebo<br>* Placebo tablet matching Empagliflozin high dose<br>Drug: Placebo<br>* Placebo tablet matching Empagliflozin low dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment | The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication. | 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28 |