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

NCT04603508 | Unknown Phase 3 DMC

• 1 other identifier: EMS0919 - Berlim 25/10
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Keywords

Dyslipidemia; Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Change from baseline in glycated hemoglobin (HbA1c) levels.

  120 days

• Percent change from baseline of LDL-c levels.

  120 days

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  150 days

Study Arms (2)

Berlim 25/10

EXPERIMENTAL

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.

Drug: BERLIM 25/10 association; Other: EMPAGLIFLOZIN PLACEBO; Other: ROSUVASTATIN CALCIUM PLACEBO

Empagliflozin + rosuvastatin calcium

ACTIVE COMPARATOR

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.

Drug: EMPAGLIFLOZIN; Drug: ROSUVASTATIN CALCIUM; Other: BERLIM 25/10 ASSOCIATION PLACEBO

Interventions

BERLIM 25/10 association DRUG

Berlim 25/10 association coated tablet.

Berlim 25/10

EMPAGLIFLOZIN DRUG

Empagliflozin 25 mg coated tablet.

Empagliflozin + rosuvastatin calcium

ROSUVASTATIN CALCIUM DRUG

Rosuvastatin 10 mg coated tablet.

Empagliflozin + rosuvastatin calcium

BERLIM 25/10 ASSOCIATION PLACEBO OTHER

Berlim 25/10 association placebo coated tablet.

Empagliflozin + rosuvastatin calcium

EMPAGLIFLOZIN PLACEBO OTHER

Empagliflozin placebo coated tablet.

Berlim 25/10

ROSUVASTATIN CALCIUM PLACEBO OTHER

Rosuvastatin placebo coated tablet.

Berlim 25/10

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

empagliflozin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Monalisa FB Oliveira, MD

CONTACT

+551938879851; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: March 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 5, 2022

Record last verified: 2022-08