NCT05028140

Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (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 Piemonte association in the treatment of type 2 diabetes mellitus

Conditions

• Type II Diabetes

Interventions

Type	Name	Description
DRUG	PIEMONTE	Piemonte association 1 coated tablet once a day
OTHER	PIEMONTE PLACEBO	Placebo of Piemonte association 1 coated tablet once a day
DRUG	EMPAGLIFLOZIN	Empagliflozin 25 mg 1 coated tablet once a day
OTHER	PLACEBO EMPAGLIFLOZIN	Placebo of empagliflozin 25 mg 1 coated tablet once a day
DRUG	PIOGLITAZONE	Pioglitazone 30 mg 1 tablet once a day
OTHER	PLACEBO PIOGLITAZONE	Placebo of pioglitazone 30 mg 1 tablet once a day

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-07-01
• Completion: 2027-09-01
• First posted: 2021-08-31
• Last updated: 2025-12-08

Locations

1 site across 1 country: Brazil