Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

May 31, 2024

Primary Completion Date

February 28, 2025

Study Completion Date

June 30, 2025

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

MADALENA ASSOCIATION

Madalena association coated tablet.

DRUG

METFORMIN

Metformin 1000 mg extended-release tablet.

DRUG

EMPAGLIFLOZIN + LINAGLIPTIN

Empagliflozin 10 mg + linagliptin 5 mg coated tablet.

OTHER

MADALENA ASSOCIATION PLACEBO

Madalena association placebo tablet.

OTHER

METFORMIN PLACEBO

Metformin placebo tablet.

OTHER

EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO

Empagliflozin + linagliptin placebo tablet.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMS

INDUSTRY