NCT04603508

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (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 25/10 association in the treatment of type 2 diabetes mellitus and dyslipidemia.

Conditions

• Type 2 Diabetes Mellitus
• Dyslipidemia

Interventions

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

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-04-01
• Completion: 2025-08-01
• First posted: 2020-10-26
• Last updated: 2022-08-05