A Phase II, Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy for 28 Days in Japanese Patients With Type 1 Diabetes Mellitus

Boehringer Ingelheim4 sites in 1 country48 target enrollmentMarch 20, 2016

ConditionsDiabetes Mellitus, Type 1

Interventionsempagliflozin low dose empagliflozin medium dose empagliflozin high dose placebo

Drugsempagliflozin medium dose empagliflozin low dose empagliflozin high dose placebo

Overview

Phase: Phase 2
Intervention: empagliflozin low dose
Conditions: Diabetes Mellitus, Type 1
Sponsor: Boehringer Ingelheim
Enrollment: 48
Locations: 4
Primary Endpoint: Change From Baseline in 24 Hour UGE on Day 7
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.

Registry

clinicaltrials.gov

Start Date

March 20, 2016

End Date

October 3, 2016

Last Updated

8 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 low dose

Intervention: empagliflozin low dose

empagliflozin medium dose

Intervention: empagliflozin medium dose

empagliflozin high dose

Intervention: empagliflozin high dose

placebo

Intervention: placebo

Outcomes

Primary Outcomes

Change From Baseline in 24 Hour UGE on Day 7

Time Frame: Baseline and 7 days

Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.