Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
Primary Purpose
Dyslipidemia Associated With Type II Diabetes Mellitus
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BERLIM 25/20 ASSOCIATION
EMPAGLIFLOZIN PLACEBO
ROSUVASTATIN CALCIUM PLACEBO
EMPAGLIFLOZIN
ROSUVASTATIN CALCIUM
BERLIM 25/20 ASSOCIATION PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia Associated With Type II Diabetes Mellitus focused on measuring Dyslipidemia, Type II 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 of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
- 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 previous therapies at a stable dose in the last 3 months;
- HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose > 100 mg/dL at the screening visit;
- Participants with high or very high cardiovascular risk according to the Brazilian guideline on the prevention of cardiovascular diseases in patients with diabetes (2017), which have not reached the goal of LDL-c ≤ 70 mg/dL or ≤ 50 mg/dL, respectively, with lifestyle changes, who are or aren't using low or moderate potency statins;
- 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;
- Participants with total cholesterol > 500 mg/dL or triglycerides > 500 mg/dL;
- Impaired renal function and end-stage renal disease;
- Participants with known heart failure, class III to IV (New York Heart Association);
- Impaired hepatic function;
- Medical history of pancreatic diseases that may suggest insulin deficiency;
- Participants who had any cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset stable angina, stroke, unstable congestive heart failure requiring treatment change), underwent revascularization or vascular surgery in the 6 months prior to screening;
- 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;
- Current medical history of cancer and/ or cancer treatment in the last 5 years;
- Participants with known uncontrolled hypothyroidism or TSH levels > 5 mIU/L;
- History of known muscle disease or prior statin intolerance;
- Participants using SGLT2 inhibitors, sulfonylureas and/or insulin therapy or PCSK9 inhibitors;
- Participants who used other medications with prominent action in the control of serum triglyceride and cholesterol levels in the last 4 weeks or who are using low or moderate-intensity statins that cannot be replaced by rosuvastatin 20 mg;
- Participants using medications that may interfere with triglyceride and cholesterol metabolism started less than 4 weeks ago or with dose adjustment in the last 4 weeks prior to the screening visit;
- 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
BERLIM 25/20
Empagliflozin + rosuvastatin calcium
Arm Description
The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/20 association, oral; 1 tablet empagliflozin placebo, oral; 1 tablet rosuvastatin calcium placebo, oral.
The patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/20 association placebo, oral; 1 tablet empagliflozin, oral; 1 tablet rosuvastatin calcium, oral.
Outcomes
Primary Outcome Measures
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
Percentual reduction of LDL-c levels measured between the first visit and the last visit.
Secondary Outcome Measures
Incidence and severity of adverse events recorded during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04602754
Brief Title
Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
Official Title
National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
August 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 Berlim 25/20 association in the treatment of type 2 diabetes mellitus and dyslipidemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia Associated With Type II Diabetes Mellitus
Keywords
Dyslipidemia, Type II Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BERLIM 25/20
Arm Type
Experimental
Arm Description
The study is triple-dummy. The patient must take 3 tablets once a day, as follows:
1 tablet Berlim 25/20 association, oral;
1 tablet empagliflozin placebo, oral;
1 tablet rosuvastatin calcium placebo, oral.
Arm Title
Empagliflozin + rosuvastatin calcium
Arm Type
Active Comparator
Arm Description
The patient must take 3 tablets once a day, as follows:
1 tablet Berlim 25/20 association placebo, oral;
1 tablet empagliflozin, oral;
1 tablet rosuvastatin calcium, oral.
Intervention Type
Drug
Intervention Name(s)
BERLIM 25/20 ASSOCIATION
Intervention Description
Berlim 25/20 association coated tablet.
Intervention Type
Other
Intervention Name(s)
EMPAGLIFLOZIN PLACEBO
Intervention Description
Empagliflozin placebo coated tablet.
Intervention Type
Other
Intervention Name(s)
ROSUVASTATIN CALCIUM PLACEBO
Intervention Description
Rosuvastatin calcium placebo coated tablet.
Intervention Type
Drug
Intervention Name(s)
EMPAGLIFLOZIN
Intervention Description
Empagliflozin 25 mg coated tablet.
Intervention Type
Drug
Intervention Name(s)
ROSUVASTATIN CALCIUM
Intervention Description
Rosuvastatin 20 mg coated tablet.
Intervention Type
Other
Intervention Name(s)
BERLIM 25/20 ASSOCIATION PLACEBO
Intervention Description
Berlim 25/20 association placebo coated tablet.
Primary Outcome Measure Information:
Title
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
Time Frame
120 days
Title
Percentual reduction of LDL-c levels measured between the first visit and the last visit.
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
Maximum Age & Unit of Time
85 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 of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
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 previous therapies at a stable dose in the last 3 months;
HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose > 100 mg/dL at the screening visit;
Participants with high or very high cardiovascular risk according to the Brazilian guideline on the prevention of cardiovascular diseases in patients with diabetes (2017), which have not reached the goal of LDL-c ≤ 70 mg/dL or ≤ 50 mg/dL, respectively, with lifestyle changes, who are or aren't using low or moderate potency statins;
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;
Participants with total cholesterol > 500 mg/dL or triglycerides > 500 mg/dL;
Impaired renal function and end-stage renal disease;
Participants with known heart failure, class III to IV (New York Heart Association);
Impaired hepatic function;
Medical history of pancreatic diseases that may suggest insulin deficiency;
Participants who had any cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset stable angina, stroke, unstable congestive heart failure requiring treatment change), underwent revascularization or vascular surgery in the 6 months prior to screening;
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;
Current medical history of cancer and/ or cancer treatment in the last 5 years;
Participants with known uncontrolled hypothyroidism or TSH levels > 5 mIU/L;
History of known muscle disease or prior statin intolerance;
Participants using SGLT2 inhibitors, sulfonylureas and/or insulin therapy or PCSK9 inhibitors;
Participants who used other medications with prominent action in the control of serum triglyceride and cholesterol levels in the last 4 weeks or who are using low or moderate-intensity statins that cannot be replaced by rosuvastatin 20 mg;
Participants using medications that may interfere with triglyceride and cholesterol metabolism started less than 4 weeks ago or with dose adjustment in the last 4 weeks prior to the screening visit;
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 Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
We'll reach out to this number within 24 hrs