Actively Recruiting
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Led by EMS · Updated on 2025-12-08
270
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
CONDITIONS
Official Title
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to voluntarily participate and sign informed consent
- Age 18 years or older
- Diagnosed with type II diabetes mellitus
- HbA1c between 7.5% and 10.5% and fasting blood glucose above 100 mg/dL at screening
- Body mass index between 19 and 45 kg/m2
- Did not meet HbA1c therapeutic goals after at least 3 months of two anti-hyperglycemic agents and lifestyle guidance
You will not qualify if you...
- Clinical or laboratory findings that may affect participant safety
- History of alcohol abuse or illicit drug use
- Participation in another clinical trial within the past year
- Pregnancy, risk of pregnancy, or breastfeeding
- Known allergy to study medications
- Type 1 diabetes mellitus
- Fasting blood glucose above 300 mg/dL
- Risk factors for volume depletion
- Impaired kidney function or end-stage renal disease
- Systemic steroid treatment for more than 15 days at consent
- Impaired liver function
- History of pancreatic diseases suggesting insulin deficiency
- Bariatric or gastrointestinal surgery in the past 2 years causing malabsorption
- Conditions that may lead to significant changes in CPK levels
- History of recent acute coronary syndrome, stroke, unstable heart failure, or respiratory failure within 6 months
- Current cancer or cancer treatment within 5 years
- History of metabolic acidosis or use of drugs causing lactic acidosis
- History of blood or hemolytic disorders
- Use of sulfonylureas or insulin therapy
- Anti-obesity drug treatment less than 2 months or recent dose changes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
EMS
Hortolândia, São Paulo, Brazil
Actively Recruiting
Research Team
M
Monalisa FB Oliveira, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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