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

EMS

Status and phase: Not yet enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus; Dyslipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04603508

EMS0919 - Berlim 25/10

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Berlim 25/10

Experimental group

Description:

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.

Treatment:

Drug: BERLIM 25/10 association

Other: EMPAGLIFLOZIN PLACEBO

Other: ROSUVASTATIN CALCIUM PLACEBO

Empagliflozin + rosuvastatin calcium

Active Comparator group

Description:

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.

Treatment:

Drug: EMPAGLIFLOZIN

Drug: ROSUVASTATIN CALCIUM

Other: BERLIM 25/10 ASSOCIATION PLACEBO