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

Sponsor
EMS
Study ID
NCT05028140
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • PIEMONTE — DRUG
    Piemonte association 1 coated tablet once a day
  • PIEMONTE PLACEBO — OTHER
    Placebo of Piemonte association 1 coated tablet once a day
  • EMPAGLIFLOZIN — DRUG
    Empagliflozin 25 mg 1 coated tablet once a day
  • PLACEBO EMPAGLIFLOZIN — OTHER
    Placebo of empagliflozin 25 mg 1 coated tablet once a day
  • PIOGLITAZONE — DRUG
    Pioglitazone 30 mg 1 tablet once a day
  • PLACEBO PIOGLITAZONE — OTHER
    Placebo of pioglitazone 30 mg 1 tablet once a day

Study Details

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

Key Dates

Start date
Oct 8, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Piemonte association
    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.
  • Active Comparator: Empagliflozin
    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.
  • Active Comparator: Pioglitazone
    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.

Primary Outcome Measure

Glycated hemoglobin [ Time Frame: 120 days ]

Central Contacts

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