A phase III, randomized, prospective, double-blind, parallel design, multi-arm, multicenter study to compare the efficacy and safety of alogliptin and empagliflozin combination therapy versus alogliptin alone and empagliflozin alone in metformin-treated participants with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise (ODISSEIA 2026).

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524606-15-00

Enrollment

760

Registered

2026-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes mellitus

Brief summary

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

Detailed description

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)., Incidence and severity of TEAEs* and SAEs according to MedDRA System Organ Class (SOC) and Preferred Terms (PT), following the latest MedDRA version available at the time of AE coding. Safety will be evaluated based on reported AEs including hypoglycemic events, physical examination findings, vital signs, laboratory values and ECG.

Interventions

DRUGPlacebo of Empagliflozin 10 mg

DRUGEmpagliflozina Pentafarma 10 mg

DRUGcomprimidos revestidos por película

DRUGALOGLIPTIN

DRUGEmpagliflozina Tecnigen 25 mg

DRUGPlacebo of Empagliflozin 25 mg

DRUGPlacebo of Alogliptin 25 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)., Incidence and severity of TEAEs* and SAEs according to MedDRA System Organ Class (SOC) and Preferred Terms (PT), following the latest MedDRA version available at the time of AE coding. Safety will be evaluated based on reported AEs including hypoglycemic events, physical examination findings, vital signs, laboratory values and ECG.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 5, 2026