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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
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 21, 2020
    Last Updated
    August 3, 2022
    Sponsor
    EMS
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    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.

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