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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 4
Enrollment
65 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
29 Oct 2015
Primary completion
2 Jun 2017
Completion
2 Jun 2017
First posted
28 Oct 2015 (estimated)
Last update posted
7 Jan 2019
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

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

    NCT02589626

    29 Oct 2015 to 2 Jun 2017

Registry summary

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

Interventions

  • empagliflozin 10mgDrug
  • empagliflozin 25 mgDrug
  • PlaceboDrug

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment

    Time frame · 52 weeks

    Registry description

    Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented

Secondary outcomes(1)
  1. Change From Baseline in HbA1c After 52 Weeks of Treatment

    Time frame · baseline and 52 weeks

    Registry description

    Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 52 weeks

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

GroupValue (Percentage of participants)
Empagliflozin 10 mg9.4
Empagliflozin 25 mg21.2
Secondary and other outcome results(1)
Secondary outcomeMean· baseline and 52 weeks

Change From Baseline in HbA1c After 52 Weeks of Treatment

GroupValue (% of HbA1c)Spread
Empagliflozin 10 mg-0.550.15
Empagliflozin 25 mg-0.770.14

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Empagliflozin 10 mgPatients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks0 / 322 / 3210 / 32
Empagliflozin 25mgPatients were orally administered film-coated tablet of Empagliflozin 10 mg once in the morning for 52 weeks0 / 331 / 3315 / 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

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2019

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 et al. 2019Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 19

PMID 30912033PMC6531579DOI 10.1007/s13300-019-0604-8PUB-30912033

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 \<=10.0% at screening * Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=9.0% at screening and \>=7.0% and \<=10.0% at placebo run-in * Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=10.0% at both screening and placebo run-in * Age at informed consent must be \>=20 years * BMI at screening must be \<=40 kg/m2 * Further inclusion criteria apply Exclusion criteria: * Uncontrolled hyperglycaemia with a glucose values \>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

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