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

August 3, 2022 updated by: EMS

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: BERLIM 25/10 association
Berlim 25/10 association coated tablet.
Other: EMPAGLIFLOZIN PLACEBO
Empagliflozin placebo coated tablet.
Other: ROSUVASTATIN CALCIUM PLACEBO
Rosuvastatin placebo coated tablet.
Active Comparator: 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.
Drug: EMPAGLIFLOZIN
Empagliflozin 25 mg coated tablet.
Drug: ROSUVASTATIN CALCIUM
Rosuvastatin 10 mg coated tablet.
Other: BERLIM 25/10 ASSOCIATION PLACEBO
Berlim 25/10 association placebo coated tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in glycated hemoglobin (HbA1c) levels.
Time Frame: 120 days
120 days
Percent change from baseline of LDL-c levels.
Time Frame: 120 days
120 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study.
Time Frame: 150 days
150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0919 - Berlim 25/10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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