Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia

NCT ID: NCT04603508

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2025-08-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Berlim 25/10 association in the treatment of type 2 diabetes mellitus and dyslipidemia.

Conditions

Type 2 Diabetes Mellitus; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Berlim 25/10

The study is triple-dummy. The patient must take 3 tablets once a day, as follows:

1 tablet Berlim 25/10 association, oral;

1 tablet empagliflozin placebo, oral;

1 tablet rosuvastatin calcium placebo, oral.

Group Type: EXPERIMENTAL

BERLIM 25/10 association

Intervention Type: DRUG

Berlim 25/10 association coated tablet.

EMPAGLIFLOZIN PLACEBO

Intervention Type: OTHER

Empagliflozin placebo coated tablet.

ROSUVASTATIN CALCIUM PLACEBO

Intervention Type: OTHER

Rosuvastatin placebo coated tablet.

Empagliflozin + rosuvastatin calcium

The patient must take 3 tablets once a day, as follows:

1 tablet Berlim 25/10 association placebo, oral;

1 tablet empagliflozin , oral;

1 tablet rosuvastatin calcium, oral.

Group Type: ACTIVE_COMPARATOR

EMPAGLIFLOZIN

Intervention Type: DRUG

Empagliflozin 25 mg coated tablet.

ROSUVASTATIN CALCIUM

Intervention Type: DRUG

Rosuvastatin 10 mg coated tablet.

BERLIM 25/10 ASSOCIATION PLACEBO

Intervention Type: OTHER

Berlim 25/10 association placebo coated tablet.

Interventions

BERLIM 25/10 association

Berlim 25/10 association coated tablet.

Intervention Type: DRUG

EMPAGLIFLOZIN

Empagliflozin 25 mg coated tablet.

Intervention Type: DRUG

ROSUVASTATIN CALCIUM

Rosuvastatin 10 mg coated tablet.

Intervention Type: DRUG

BERLIM 25/10 ASSOCIATION PLACEBO

Berlim 25/10 association placebo coated tablet.

Intervention Type: OTHER

EMPAGLIFLOZIN PLACEBO

Empagliflozin placebo coated tablet.

Intervention Type: OTHER

ROSUVASTATIN CALCIUM PLACEBO

Rosuvastatin placebo coated tablet.

Intervention Type: OTHER

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 low or intermediary 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 ≤ 100 mg/dL with lifestyle changes, who are or aren't using low-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;
• 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-intensity statins that cannot be replaced by rosuvastatin 10 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Monalisa FB Oliveira, MD

Role: CONTACT

pesquisa.clinica@ncfarma.com.br

+551938879851

Other Identifiers

EMS0919 - Berlim 25/10

Identifier Type: -

Identifier Source: org_study_id