Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus

Official title

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.

Overview

The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.

Interventions

• 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.

Primary outcome measures

• Change from baseline in glycated hemoglobin (HbA1c) levels. [Time frame: 120 days]

Secondary outcome measures (1)

• Incidence and severity of adverse events recorded during the study. [Time frame: 150 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• EMS — Hortolândia

Identifiers

NCT: NCT04670666 · EMS1419 - MADALENA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗