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

NCT04970108 | Withdrawn Phase 3 DMC

• 1 other identifier: EMS1120 - Egito
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension Associated; Type II Diabetes Mellitus

Keywords

Hypertension; Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin

  Changes from baseline in glycated hemoglobin

  120 days

• Systolic blood pressure (SBP)

  Changes from baseline in SBP in ambulatory blood pressure monitoring

  120 days

Secondary Outcomes (1)

• Adverse events

  150 days

Study Arms (2)

Egito

EXPERIMENTAL

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

Empagliflozin + telmisartan

ACTIVE COMPARATOR

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

Interventions

Egito DRUG

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

Egito

Empagliflozin + telmisartan DRUG

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

Empagliflozin + telmisartan

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

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

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

empagliflozin; Telmisartan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: July 16, 2021
• First Posted: July 21, 2021
• Study Start: August 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 8, 2023

Record last verified: 2023-09