EGITO: Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension

Sponsor

EMS (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04970108

Collaborator

(none)

320

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Egito association in the treatment of type 2 diabetes mellitus and hypertension

Condition or Disease	Intervention/Treatment	Phase
Hypertension Associated Type II Diabetes Mellitus	Drug: Egito Drug: Empagliflozin + telmisartan	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Egito The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Egito, oral; 1 tablet empagliflozin placebo, oral; 1 tablet telmisartan placebo, oral.	Drug: Egito EGITO Egito coated tablet. EMPAGLIFLOZIN PLACEBO Empagliflozin placebo coated tablet. TELMISARTAN PLACEBO Telmisartan coated tablet.
Active Comparator: Empagliflozin + telmisartan The patient must take 3 tablets once a day, as follows: 1 tablet Egito placebo, oral; 1 tablet empagliflozin, oral; 1 tablet telmisartan, oral.	Drug: Empagliflozin + telmisartan Drug: EMPAGLIFLOZIN Empagliflozin 25 mg coated tablet. Drug: TELMISARTAN Telmisartan 40/80 mg coated tablet. EGITO PLACEBO Egito placebo coated tablet.

Arm

Intervention/Treatment

Experimental: Egito

The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Egito, oral; 1 tablet empagliflozin placebo, oral; 1 tablet telmisartan placebo, oral.

Drug: Egito

EGITO Egito coated tablet. EMPAGLIFLOZIN PLACEBO Empagliflozin placebo coated tablet. TELMISARTAN PLACEBO Telmisartan coated tablet.

Active Comparator: Empagliflozin + telmisartan

The patient must take 3 tablets once a day, as follows: 1 tablet Egito placebo, oral; 1 tablet empagliflozin, oral; 1 tablet telmisartan, oral.

Drug: Empagliflozin + telmisartan

Drug: EMPAGLIFLOZIN Empagliflozin 25 mg coated tablet. Drug: TELMISARTAN Telmisartan 40/80 mg coated tablet. EGITO PLACEBO Egito placebo coated tablet.

Outcome Measures

Primary Outcome Measures

Glycated hemoglobin [120 days]
Changes from baseline in glycated hemoglobin
Systolic blood pressure (SBP) [120 days]
Changes from baseline in SBP in ambulatory blood pressure monitoring

Secondary Outcome Measures

Adverse events [150 days]
Incidence and severity of adverse events recorded during the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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;
Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.

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 any of the formula compounds;
Type 1 diabetes mellitus;
Known or suspected secondary hypertension.