Trials / Recruiting
RecruitingNCT04670666
Efficacy and Safety of Madalena 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 Madalena Association in the Treatment of Type II Diabetes Mellitus.
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- EMS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MADALENA ASSOCIATION | Madalena association coated tablet. |
| DRUG | METFORMIN | Metformin 1000 mg extended-release tablet. |
| DRUG | EMPAGLIFLOZIN + LINAGLIPTIN | Empagliflozin 10 mg + linagliptin 5 mg coated tablet. |
| OTHER | MADALENA ASSOCIATION PLACEBO | Madalena association placebo tablet. |
| OTHER | METFORMIN PLACEBO | Metformin placebo tablet. |
| OTHER | EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO | Empagliflozin + linagliptin placebo tablet. |
Timeline
- Start date
- 2024-11-18
- Primary completion
- 2026-07-01
- Completion
- 2027-06-01
- First posted
- 2020-12-17
- Last updated
- 2025-12-08
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04670666. Inclusion in this directory is not an endorsement.