A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

Sponsor
Boryung Pharmaceutical Co., Ltd
Study ID
NCT04885712
Phase
PHASE3
Status
Completed

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin≥1000mg — DRUG
    Subjects take the investigational products once a day for 24 weeks.
  • Pioglitazone 15mg — DRUG
    Subjects take the investigational products once a day for 24 weeks.
  • Pioglitazone 30 mg — DRUG
    Subjects take the investigational products once a day for 24 weeks.
  • Pioglitazone 15mg Placebo — DRUG
    Subjects take the investigational products once a day for 24 weeks.
  • Pioglitazone 30mg Placebo — DRUG
    Subjects take the investigational products once a day for 24 weeks.
  • Dapagliflozin 10mg — DRUG
    Subjects take the investigational products once a day for 24 weeks.

Study Details

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or Pioglitazone 30mg Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin

Key Dates

Start date
May 28, 2021
Status verified
May 2023
Primary completion
Sep 19, 2022
Completion
Mar 10, 2023

Study Design

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

Arms

  • Experimental: Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
    Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
  • Experimental: Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
    Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
  • Active Comparator: Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
    Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo

Primary Outcome Measure

Changes in HbA1c [ Time Frame: 24th week ]

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