Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
| Group | Value (Percentage of participants) |
|---|---|
| Empagliflozin 10 mg | 9.4 |
| Empagliflozin 25 mg | 21.2 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
Japan
1 trial · 1 completed · 1 with posted results
Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA
NCT0258962629 Oct 2015 to 2 Jun 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
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
Outcomes the sponsor listed as primary.
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
Change From Baseline in HbA1c After 52 Weeks of Treatment
Time frame · baseline and 52 weeks
Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of participants) |
|---|---|
| Empagliflozin 10 mg | 9.4 |
| Empagliflozin 25 mg | 21.2 |
| Group | Value (% of HbA1c) | Spread |
|---|---|---|
| Empagliflozin 10 mg | -0.55 | 0.15 |
| Empagliflozin 25 mg | -0.77 | 0.14 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Empagliflozin 10 mgPatients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks | 0 / 32 | 2 / 32 | 10 / 32 |
| Empagliflozin 25mgPatients were orally administered film-coated tablet of Empagliflozin 10 mg once in the morning for 52 weeks | 0 / 33 | 1 / 33 | 15 / 33 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
PubMed tag: none · 2019
Terauchi et al. 2019Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 19
PMID 30912033PMC6531579DOI 10.1007/s13300-019-0604-8PUB-30912033
Who could join, as posted.
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