Study S002442

A 52-week Randomised, Double-blind, Parallel Group, Safety and Efficacy Study of Empagliflozin Once Daily as add-on Therapy to Glucagon-like Peptide-1 Receptor Agonist in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02589626
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: DOUBLE
Status: COMPLETED
Enrollment: 65
Start: 2015-10-29
Primary completion: 2017-06-02
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:empagliflozin 10mg; DRUG:empagliflozin 25 mg; DRUG:Placebo
Results posted: TRUE

Registered primary outcomes

Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment [52 weeks]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0016786	Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study. Terauchi Y, Diabetes therapy : research, treatment and education of diabetes and related disorders	2019	Randomized trial	PMID 30912033 DOI	cites ClinicalTrials.gov:NCT02589626; registry reference DERIVED:30912033