GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

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

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

Lead sponsor

Boehringer Ingelheim

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≤40

Primary endpoint

•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02589626

Org study ID1245.106

Timeline

Milestones

Study first posted2015-10-28estimated

Study start2015-10-29actual

Primary completion2017-06-02actual

Study completion2017-06-02actual

Last update posted2019-01-07actual

Results first posted2019-01-07actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change From Baseline in HbA1c After 52 Weeks of Treatment

Time frame:baseline and 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), % of HbA1c	95% CI
Empagliflozin 10 mg	-0.55	—
Empagliflozin 25 mg	-0.77	—

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

Time frame:52 weeks

Treatment-emergent AEs (any)

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	95% CI
Empagliflozin 10 mg	9.4	—
Empagliflozin 25 mg	21.2	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
Diabetes therapy : research, treatment and education of diabetes and related disorders2019 Jun (month)PMID30912033doi:10.1007/s13300-019-0604-8via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.