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

Boehringer Ingelheim48 sites in 1 country269 target enrollmentOctober 28, 2015

ConditionsDiabetes Mellitus, Type 2

InterventionsPlacebo Empagliflozin

DrugsEmpagliflozin Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Enrollment: 269
Locations: 48
Primary Endpoint: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

October 28, 2015

End Date

January 5, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

empagliflozin 10 mg

Intervention: Placebo

empagliflozin 25 mg

Intervention: Empagliflozin

empagliflozin 10 mg

Intervention: Empagliflozin

empagliflozin 25 mg

Intervention: Placebo

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.

Time Frame: Baseline and 16 weeks

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.

Secondary Outcomes

Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)(From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks)