Phase 4
Completed N=65
Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA
Source: ClinicalTrials.gov NCT02589626 ↗Enrolled (actual)
65
Serious AEs
4.6%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment — 9.4; 21.2 Percentage of participants
◆ Published Evidence
Established
22citations · ~3 / year
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.
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
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment |
9.4; 21.2 | — |
| SECONDARY Change From Baseline in HbA1c After 52 Weeks of Treatment |
-0.55; -0.77 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus
- Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be >=7.0% and =7.0% and =7.0% and =7.0% and =20 years
- BMI at screening must be 270 mg/dL (>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement
- Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.
- Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent
- Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period
- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02589626) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.