Madalena combination for treating type 2 diabetes

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.

This trial will test whether the Madalena combination helps adults with type 2 diabetes who haven't reached blood sugar targets while on two medicines.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ems (Industry-sponsored)
• Locations: 1 site (Hortolândia, São Paulo)
• Trial ID: NCT04670666 on ClinicalTrials.gov

What this trial studies

This is a phase 3 interventional trial comparing the Madalena association to standard oral therapies and matching placebos in adults with type 2 diabetes who remain above glycemic targets on dual therapy. Eligible participants have HbA1c between 7.5% and 10.5%, fasting glucose >100 mg/dL, and BMI 19–45 kg/m2. Participants will be assigned to receive Madalena association, metformin, empagliflozin plus linagliptin, or corresponding placebos, with treatment and safety outcomes monitored over the study period. Primary outcomes will focus on changes in HbA1c and safety/tolerability measures.

Who should consider this trial

Good fit: Adults aged 18 or older with type 2 diabetes who have been on at least two antihyperglycemic agents for three months, with HbA1c 7.5–10.5% and BMI 19–45 kg/m2, are ideal candidates.

Not a fit: Patients who are pregnant or lactating, have known hypersensitivity to study components, recent participation in other trials, substance abuse history, or already have well-controlled diabetes (HbA1c <7.5%) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the Madalena combination could help people with type 2 diabetes lower their HbA1c when two prior medicines have not been enough.

How similar studies have performed: Standard drugs like metformin and the empagliflozin+linagliptin combination have documented benefits, but the Madalena association appears to be a newer formulation with limited published phase-3 evidence to date.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to the formula components used during the clinical trial;
* Type 1 diabetes mellitus;
* Fasting blood glucose \> 300 mg/dL;
* Risk factors for volume depletion;
* Impaired renal function and end-stage renal disease;
* Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;
* Impaired hepatic function;
* 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;
* Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;
* 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;
* 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.

Where this trial is running

Hortolândia, São Paulo

• Ems — Hortolândia, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Monalisa FB Oliveira, MD

Conditions Type 2 Diabetes Mellitus