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Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus (PIEMONTE)

Primary Purpose

Type II Diabetes

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PIEMONTE
PIEMONTE PLACEBO
EMPAGLIFLOZIN
PLACEBO EMPAGLIFLOZIN
PIOGLITAZONE
PLACEBO PIOGLITAZONE
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes focused on measuring Type II diabetes mellitus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
  • Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months.

Exclusion Criteria:

  • Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of 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 pregnacy and lactating participants;
  • Known hypersensitivity to any of the formula compounds;
  • Type 1 diabetes.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Piemonte association

    Empagliflozin

    Pioglitazone

    Arm Description

    The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 tablet Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.

    The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.

    The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 tablet of piglitazone, oral.

    Outcomes

    Primary Outcome Measures

    Glycated hemoglobin
    Change from baseline in glycated hemoglobin

    Secondary Outcome Measures

    Adverse events
    Incidence and severity of adverse events recorded during the study

    Full Information

    First Posted
    August 25, 2021
    Last Updated
    March 24, 2023
    Sponsor
    EMS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05028140
    Brief Title
    Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
    Acronym
    PIEMONTE
    Official Title
    National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type II Diabetes
    Keywords
    Type II diabetes mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Piemonte association
    Arm Type
    Experimental
    Arm Description
    The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 tablet Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.
    Arm Title
    Empagliflozin
    Arm Type
    Active Comparator
    Arm Description
    The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.
    Arm Title
    Pioglitazone
    Arm Type
    Active Comparator
    Arm Description
    The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 tablet of piglitazone, oral.
    Intervention Type
    Drug
    Intervention Name(s)
    PIEMONTE
    Intervention Description
    Piemonte association 1 coated tablet once a day
    Intervention Type
    Other
    Intervention Name(s)
    PIEMONTE PLACEBO
    Intervention Description
    Placebo of Piemonte association 1 coated tablet once a day
    Intervention Type
    Drug
    Intervention Name(s)
    EMPAGLIFLOZIN
    Intervention Description
    Empagliflozin 25 mg 1 coated tablet once a day
    Intervention Type
    Other
    Intervention Name(s)
    PLACEBO EMPAGLIFLOZIN
    Intervention Description
    Placebo of empagliflozin 25 mg 1 coated tablet once a day
    Intervention Type
    Drug
    Intervention Name(s)
    PIOGLITAZONE
    Intervention Description
    Pioglitazone 30 mg 1 tablet once a day
    Intervention Type
    Other
    Intervention Name(s)
    PLACEBO PIOGLITAZONE
    Intervention Description
    Placebo of pioglitazone 30 mg 1 tablet once a day
    Primary Outcome Measure Information:
    Title
    Glycated hemoglobin
    Description
    Change from baseline in glycated hemoglobin
    Time Frame
    120 days
    Secondary Outcome Measure Information:
    Title
    Adverse events
    Description
    Incidence and severity of adverse events recorded during the study
    Time Frame
    150 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form; Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months. Exclusion Criteria: Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of 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 pregnacy and lactating participants; Known hypersensitivity to any of the formula compounds; Type 1 diabetes.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arthur M Kummer, MD, PhD
    Phone
    +551938879851
    Email
    pesquisa.clinica@ncfarma.com.br

    12. IPD Sharing Statement

    Learn more about this trial

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

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