NCT04602754

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

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-05-01
• Completion: 2027-09-01
• First posted: 2020-10-26
• Last updated: 2025-12-08

Locations

1 site across 1 country: Brazil