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

Sponsor
EMS
Study ID
NCT04970108
Phase
PHASE3
Status
Withdrawn

Conditions

  • Hypertension Associated
  • Type II Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Egito — DRUG
    EGITO Egito coated tablet. EMPAGLIFLOZIN PLACEBO Empagliflozin placebo coated tablet. TELMISARTAN PLACEBO Telmisartan coated tablet.
  • Empagliflozin + telmisartan — DRUG
    Drug: EMPAGLIFLOZIN Empagliflozin 25 mg coated tablet. Drug: TELMISARTAN Telmisartan 40/80 mg coated tablet. EGITO PLACEBO Egito placebo coated tablet.

Study Details

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

Key Dates

First listed
Jul 21, 2021
Start date
Aug 31, 2023
Status verified
Sep 2023
Primary completion
Jan 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Glycated hemoglobin [ Time Frame: 120 days ]

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