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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947855
• Other study ID #: 1245.35
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2013
• Last updated: December 16, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Placebo tablet matching Empagliflozin low dose
• Empagliflozin
Empagliflozin low dose
• Placebo
Placebo tablet matching Empagliflozin high dose
• Placebo
Placebo tablet matching Empagliflozin low dose
• Empagliflozin
Empagliflozin high dose tablet once daily
• Placebo
Placebo tablet matching Empagliflozin high dose

Locations

Country	Name	City	State
Japan	1245.35.002 Boehringer Ingelheim Investigational Site	Shinjyuku-ku, Tokyo
Japan	1245.35.001 Boehringer Ingelheim Investigational Site	Suita-shi, Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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