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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension

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

Conditions
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Type II Diabetes Mellitus, Hypertension Associated

Intervention / Treatment
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* Drug: Atenas
* Drug: Atenas placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atenas association<br>The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Atenas, oral; 1 tablet empagliflozin placebo, oral; 1 tablet telmisartan + amlodipine placebo, oral. | Drug: Atenas<br>* ATENAS 1 coated tablet, once a day EMPAGLIFLOZIN PLACEBO Empagliflozin placebo 1 coated tablet, once a day TELMISARTAN + AMLODIPINE PLACEBO Telmisartan + amlodipine 1 coated tablet, once a day<br>|
| Active Comparator: Empagliflozin + telmisartan + amlodipine<br>The patient must take 3 tablets once a day, as follows: 1 tablet Atenas placebo, oral; 1 tablet empagliflozin, oral; 1 tablet telmisartan + amlodipine, oral. | Drug: Atenas placebo<br>* Drug: EMPAGLIFLOZIN Empagliflozin 25 mg 1 coated tablet, once a day. Drug: TELMISARTAN Telmisartan + Amlodipine 40 + 5/80 +5 mg 1 coated tablet, once a day ATENAS PLACEBO Atenas placebo 1 coated tablet, once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence and severity of adverse events recorded during the study | 150 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Type II Diabetes Mellitus