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

Sponsor
EMS
Study ID
NCT04670666
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MADALENA ASSOCIATION — DRUG
    Madalena association coated tablet.
  • METFORMIN — DRUG
    Metformin 1000 mg extended-release tablet.
  • EMPAGLIFLOZIN + LINAGLIPTIN — DRUG
    Empagliflozin 10 mg + linagliptin 5 mg coated tablet.
  • MADALENA ASSOCIATION PLACEBO — OTHER
    Madalena association placebo tablet.
  • METFORMIN PLACEBO — OTHER
    Metformin placebo tablet.
  • EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO — OTHER
    Empagliflozin + linagliptin placebo tablet.

Study Details

The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.

Key Dates

Start date
Nov 18, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MADALENA
    The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Madalena association, oral; 1 tablet empagliflozin + linagliptin association placebo, oral; 1 tablet metformin placebo, oral.
  • Active Comparator: Metformin + empagliflozin + linagliptin
    The patient must take 3 tablets once a day, as follows: 1 tablet Madalena association placebo, oral; 1 tablet empagliflozin + linagliptin association, oral; 1 tablet metformin, oral.

Primary Outcome Measure

Change from baseline in glycated hemoglobin (HbA1c) levels. [ Time Frame: 120 days ]

Central Contacts

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