Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA

Sponsor
Boehringer Ingelheim
Study ID
NCT02589626
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

Key Dates

Start date
Oct 29, 2015
Status verified
Jan 2019
Primary completion
Jun 2, 2017
Completion
Jun 2, 2017

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: empagliflozin 10 mg
    empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
  • Experimental: empagliflozin 25 mg
    empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet

Primary Outcome Measure

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

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