Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.

Sponsor
EMS
Study ID
NCT04602754
Phase
PHASE3
Status
Recruiting
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Conditions

  • Dyslipidemia Associated With Type II Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • BERLIM 25/20 ASSOCIATION — DRUG
    Berlim 25/20 association coated tablet.
  • EMPAGLIFLOZIN PLACEBO — OTHER
    Empagliflozin placebo coated tablet.
  • ROSUVASTATIN CALCIUM PLACEBO — OTHER
    Rosuvastatin calcium placebo coated tablet.
  • EMPAGLIFLOZIN — DRUG
    Empagliflozin 25 mg coated tablet.
  • ROSUVASTATIN CALCIUM — DRUG
    Rosuvastatin 20 mg coated tablet.
  • BERLIM 25/20 ASSOCIATION PLACEBO — OTHER
    Berlim 25/20 association placebo coated tablet.

Study Details

The purpose of this study is to evaluate the efficacy and safety of Berlim 25/20 association in the treatment of type 2 diabetes mellitus and dyslipidemia.

Key Dates

Start date
Dec 1, 2023
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: BERLIM 25/20
    The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/20 association, oral; 1 tablet empagliflozin placebo, oral; 1 tablet rosuvastatin calcium placebo, oral.
  • Active Comparator: Empagliflozin + rosuvastatin calcium
    The patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/20 association placebo, oral; 1 tablet empagliflozin, oral; 1 tablet rosuvastatin calcium, oral.

Primary Outcome Measure

Reduction of glycated hemoglobin levels measured between the first visit and the last visit. [ Time Frame: 120 days ]

Central Contacts