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
Overview
- Phase
- Phase 4
- Intervention
- empagliflozin 10mg
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 65
- Locations
- 16
- Primary Endpoint
- Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
empagliflozin 10 mg
empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
Intervention: empagliflozin 10mg
empagliflozin 10 mg
empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
Intervention: Placebo
empagliflozin 25 mg
empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
Intervention: empagliflozin 25 mg
empagliflozin 25 mg
empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
Time Frame: 52 weeks
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented
Secondary Outcomes
- Change From Baseline in HbA1c After 52 Weeks of Treatment(baseline and 52 weeks)