Clinical trial NCT04670666: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change from baseline in glycated hemoglobin (HbA1c) levels.
timeFrame: 120 days
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 150 days
Other outcomes:
Locations:
Study officials:
References: