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

September 5, 2023 updated by: EMS

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

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;
  • 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.

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: 120 days
Changes from baseline in glycated hemoglobin
120 days
Systolic blood pressure (SBP)
Time Frame: 120 days
Changes from baseline in SBP in ambulatory blood pressure monitoring
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 150 days
Incidence and severity of adverse events recorded during the study
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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS1120 - Egito

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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