Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia

Sponsor
EMS
Study ID
NCT04603508
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • BERLIM 25/10 association — DRUG
    Berlim 25/10 association coated tablet.
  • EMPAGLIFLOZIN — DRUG
    Empagliflozin 25 mg coated tablet.
  • ROSUVASTATIN CALCIUM — DRUG
    Rosuvastatin 10 mg coated tablet.
  • BERLIM 25/10 ASSOCIATION PLACEBO — OTHER
    Berlim 25/10 association placebo coated tablet.
  • EMPAGLIFLOZIN PLACEBO — OTHER
    Empagliflozin placebo coated tablet.
  • ROSUVASTATIN CALCIUM PLACEBO — OTHER
    Rosuvastatin placebo coated tablet.

Study Details

The purpose of this study is to evaluate the efficacy and safety of Berlim 25/10 association in the treatment of type 2 diabetes mellitus and dyslipidemia.

Key Dates

Start date
Mar 31, 2023
Status verified
Aug 2022
Primary completion
Apr 30, 2025
Completion
Aug 31, 2025

Study Design

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

Arms

  • Experimental: Berlim 25/10
    The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/10 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 25/10 association placebo, oral; 1 tablet empagliflozin , oral; 1 tablet rosuvastatin calcium, oral.

Primary Outcome Measure

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

Central Contacts

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