Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

Comparison of absolute change from baseline in HbA1c (measured in %) across treatment arms.

Secondary Outcomes (6)

Comparison of change (%) from baseline in HbA1c.
Mean change from baseline (%) in HbA1c.
Comparison of change (%) from baseline in FPG.
Mean change from baseline (%) in FPG.
Proportion of participants achieving HbA1c < 7% (<53 mmol/mol).
+1 more secondary outcomes

Interventions

Placebo of Empagliflozin 10 mgType not reported

Empagliflozina Pentafarma 10 mg, comprimidos revestidos por películaType not reported

ALOGLIPTIN Type not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Empagliflozina Pentafarma 10 mg, comprimidos revestidos por película
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Empagliflozina Tecnigen 25 mg, comprimidos revestidos por película
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Empagliflozina Pentafarma 10 mg, comprimidos revestidos por película
Named ingredient: empagliflozin
View registry record
Empagliflozina Tecnigen 25 mg, comprimidos revestidos por película
Named ingredient: empagliflozin
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or non-pregnant, non-lactating female participants aged ≥18 years at the time of signing the Informed Consent Form (ICF), with a diagnosis of T2DM.
Persistent hyperglycemia while on a stable regimen of metformin (≥ 1500 mg/day or maximum tolerated/local labelled dose) and diet and exercise regimen for at least 12 weeks prior to screening.

Sponsors & Collaborators

Tecnimede-Sociedade Tecnico-Medicinal S.A.
Industrylead

Study Sites (43)

FutureMeds GmbH

Berlin, 10629, Germany

Konrad Janik+4930439741610 konrad.janik@futuremeds.com

FutureMeds GmbH

Offenbach Am Main, 63065, Germany

Christel Contzen+4969247433849 christel.contzen@futuremeds.com

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Valeria Grancini00393926233299

Central Study Contacts

Departamento Médico do Grupo Tecnimede

00351210414100 dmed.ct@tecnimede.pt

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

May 8, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-524606-15-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:42:41 UTC

Documents

D1_ Protocol_2025-524606-15-00_redacted

You may not qualify if:

Severe allergy to study drugs, their classes, or excipients.
Smoking of more than 10 cigarettes or 3 cigars or 3 pipes per day at screening.
Participation in weight-loss programs and/or use of weight-loss medications in the last 12 weeks.
Participation in another trial where an investigational drug (non-antidiabetic) has been administered within 90 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigation drug.
Institutionalized participants.
History of Type 1 diabetes or secondary diabetes.
Pregnant or lactating participants.
Confirmed fasting plasma glucose (FPG) > 240 mg/dL (>13.3 mmol/L) after an overnight fast (minimum 8 hours), based on two measurements prior to randomization.
Moderate (eGFR of 30 - <60 mL/min/1.73 m²) to severe (eGFR <30 mL/min/1.73 m²) renal impairment.
Severe liver disease, defined as a Child-Pugh score > 9 (10 to 15), corresponding to Child-Pugh class C.
Essential hypertension diagnosed and treated but uncontrolled, defined as systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg despite ongoing antihypertensive therapy
Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or TIA within 3 months prior screening.
History of congestive heart failure NYHA classification class III/IV, or unstable or acute congestive heart failure. Patients with atherosclerotic cardiovascular disease and heart failure with reduced or preserved ejection fraction NYHA classification class II should also be excluded, unless GLP-1 receptor agonist therapy is contraindicated, not tolerated, or declined by the participant after appropriate medical counselling.
Clinically significant ECG abnormalities at screening that, in the opinion of the Investigator, indicate unstable cardiovascular disease, clinically relevant arrhythmias, second- or third-degree atrioventricular block (unless treated with a functioning pacemaker), QTc prolongation (>500 ms), or any abnormality considered to increase the risk of study participation.
History of malignancies in the last 5 years (except in situ or basal/squamous cell skin cancer).
+6 more criteria

Study of a DPP 4 inhibitor and an SGLT2 inhibitor used together compared with each treatment alone in adults with type 2 diabetes treated with metformin.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations