Back to resultsEfficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MADALENA ASSOCIATION
METFORMIN
EMPAGLIFLOZIN + LINAGLIPTIN
MADALENA ASSOCIATION PLACEBO
METFORMIN PLACEBO
EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MADALENA
Metformin + empagliflozin + linagliptin
Arm Description
The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Madalena association, oral; 1 tablet empagliflozin + linagliptin association placebo, oral; 1 tablet metformin placebo, oral.
The patient must take 3 tablets once a day, as follows: 1 tablet Madalena association placebo, oral; 1 tablet empagliflozin + linagliptin association, oral; 1 tablet metformin, oral.
Outcomes
Primary Outcome Measures
Change from baseline in glycated hemoglobin (HbA1c) levels.
Secondary Outcome Measures
Incidence and severity of adverse events recorded during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04670666
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MADALENA
Arm Type
Experimental
Arm Description
The study is triple-dummy. The patient must take 3 tablets once a day, as follows:
1 tablet Madalena association, oral;
1 tablet empagliflozin + linagliptin association placebo, oral;
1 tablet metformin placebo, oral.
Arm Title
Metformin + empagliflozin + linagliptin
Arm Type
Active Comparator
Arm Description
The patient must take 3 tablets once a day, as follows:
1 tablet Madalena association placebo, oral;
1 tablet empagliflozin + linagliptin association, oral;
1 tablet metformin, oral.
Intervention Type
Drug
Intervention Name(s)
MADALENA ASSOCIATION
Intervention Description
Madalena association coated tablet.
Intervention Type
Drug
Intervention Name(s)
METFORMIN
Intervention Description
Metformin 1000 mg extended-release tablet.
Intervention Type
Drug
Intervention Name(s)
EMPAGLIFLOZIN + LINAGLIPTIN
Intervention Description
Empagliflozin 10 mg + linagliptin 5 mg coated tablet.
Intervention Type
Other
Intervention Name(s)
MADALENA ASSOCIATION PLACEBO
Intervention Description
Madalena association placebo tablet.
Intervention Type
Other
Intervention Name(s)
METFORMIN PLACEBO
Intervention Description
Metformin placebo tablet.
Intervention Type
Other
Intervention Name(s)
EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
Intervention Description
Empagliflozin + linagliptin placebo tablet.
Primary Outcome Measure Information:
Title
Change from baseline in glycated hemoglobin (HbA1c) levels.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study.
Time Frame
150 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monalisa FB Oliveira, MD
Phone
+551938879851
Email
pesquisa.clinica@ncfarma.com.br
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
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