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Withdrawn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

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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