Tests the Madalena combination drug in adults with type 2 diabetes
Tests the Madalena combination drug in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Key facts
- Where
- Hortolândia, BrazilSee the site
- Phase
- Phase 3
Where in Brazil
- EMSHortolândia, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EMS
- Trial code
- NCT04670666
- Record updated
- 8 December 2025
- Original description
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.Read full original descriptionShow less
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.
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
Inclusion: Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; Participants with 18 years of age or greater; Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy); HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose > 100 mg/dL at the screening visit; BMI (body mass index) > 19 Kg/m2 and ≤ 45 Kg/m2.
Exclusion: Participation in a clinical trial in the year prior to this study; Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent; Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent; Participants using sulfonylureas and/or insulin therapy; Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months; History of alcohol abuse or illicit drug use; Known hypersensitivity to the formula components used during the clinical trial; Type 1 diabetes mellitus; Impaired renal function and end-stage renal disease; Medical history of pancreatic diseases that may suggest insulin deficiency; Bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome; Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels; Current medical history of cancer and/ or cancer treatment in the last 5 years; Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis; Medical history of blood dyscrasia or any other hemolytic disorders; Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; Fasting blood glucose > 300 mg/dL; Pregnancy or risk of pregnancy and lactating patients; Risk factors for volume depletion; Impaired hepatic function.