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.

NCT04603508 Phase 3 UNKNOWN

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.

Details

Lead sponsor	EMS
Phase	Phase 3
Status	UNKNOWN
Enrolment	240
Start date	2023-03
Completion	2025-08

Conditions

• Type 2 Diabetes Mellitus
• Dyslipidemia

Interventions

• BERLIM 25/10 association
• EMPAGLIFLOZIN
• ROSUVASTATIN CALCIUM
• BERLIM 25/10 ASSOCIATION PLACEBO
• EMPAGLIFLOZIN PLACEBO
• ROSUVASTATIN CALCIUM PLACEBO

Primary outcomes

• Change from baseline in glycated hemoglobin (HbA1c) levels. — 120 days
• Percent change from baseline of LDL-c levels. — 120 days