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.

NCT04602754 Phase 3 RECRUITING

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.

Details

Lead sponsor	EMS
Phase	Phase 3
Status	RECRUITING
Enrolment	228
Start date	2023-12-01
Completion	2027-09

Conditions

• Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

• BERLIM 25/20 ASSOCIATION
• EMPAGLIFLOZIN PLACEBO
• ROSUVASTATIN CALCIUM PLACEBO
• EMPAGLIFLOZIN
• ROSUVASTATIN CALCIUM
• BERLIM 25/20 ASSOCIATION PLACEBO

Primary outcomes

• Reduction of glycated hemoglobin levels measured between the first visit and the last visit. — 120 days
• Percentual reduction of LDL-c levels measured between the first visit and the last visit. — 120 days

Countries

Brazil