Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus
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.
Interventions
DRUGMADALENA ASSOCIATION
Madalena association coated tablet.
DRUGMETFORMIN
Metformin 1000 mg extended-release tablet.
Empagliflozin 10 mg + linagliptin 5 mg coated tablet.
OTHERMADALENA ASSOCIATION PLACEBO
Madalena association placebo tablet.
OTHERMETFORMIN PLACEBO
Metformin placebo tablet.
OTHEREMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
Empagliflozin + linagliptin placebo tablet.
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in glycated hemoglobin (HbA1c) levels. | 120 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events recorded during the study. | 150 days |
Countries
Brazil
Contacts
Primary ContactMonalisa FB Oliveira, MD
Outcome results
None listed