Actively Recruiting
Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
Led by EMS · Updated on 2025-12-08
228
Participants Needed
1
Research Sites
195 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 Berlim 25/20 association in the treatment of type 2 diabetes mellitus and dyslipidemia.
CONDITIONS
Official Title
Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give informed consent for the trial
- Both men and women, aged 18 to 85 years
- Diagnosed with type II diabetes mellitus not reaching HbA1c targets after diet, exercise, and stable therapy for 3 months
- HbA1c between 7.5% and 10.5% and fasting blood glucose over 100 mg/dL at screening
- High or very high cardiovascular risk with LDL-c above 70 mg/dL or 50 mg/dL despite lifestyle changes, with or without low/moderate statins
- Body mass index (BMI) between over 19 and 45 Kg/m2
You will not qualify if you...
- Any clinical or lab findings that may affect participant safety
- History of alcohol abuse or illicit drug use
- Participation in another clinical trial in the past year
- Pregnancy, risk of pregnancy, or breastfeeding
- Known allergy to trial formula components
- Type 1 diabetes mellitus
- Fasting blood glucose over 300 mg/dL
- Risk factors for volume depletion
- Total cholesterol or triglycerides over 500 mg/dL
- Impaired kidney function or end-stage kidney disease
- Known heart failure class III or IV
- Impaired liver function
- History of pancreatic disease suggesting insulin deficiency
- Cardiovascular events or related surgeries within 6 months before screening
- Bariatric or gastrointestinal surgeries causing malabsorption in the last 2 years
- Conditions possibly causing significant CPK level changes
- Current or recent (last 5 years) cancer history or treatment
- Uncontrolled hypothyroidism or TSH levels over 5 mIU/L
- History of muscle disease or statin intolerance
- Use of SGLT2 inhibitors, sulfonylureas, insulin, or PCSK9 inhibitors
- Use of medications affecting triglycerides or cholesterol started or adjusted less than 4 weeks ago
- Anti-obesity drug use less than 2 months or recent dose changes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Allergisa
Campinas, São Paulo, Brazil
Actively Recruiting
Research Team
C
Cassiano O Berto, BD
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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