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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

NCT04885712 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2023-05-24

No results posted yet for this study

Summary

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

Conditions

  • Type2 Diabetes

Interventions

DRUG

Metformin≥1000mg

Subjects take the investigational products once a day for 24 weeks.

DRUG

Pioglitazone 15mg

Subjects take the investigational products once a day for 24 weeks.

DRUG

Pioglitazone 30 mg

Subjects take the investigational products once a day for 24 weeks.

DRUG

Pioglitazone 15mg Placebo

Subjects take the investigational products once a day for 24 weeks.

DRUG

Pioglitazone 30mg Placebo

Subjects take the investigational products once a day for 24 weeks.

DRUG

Dapagliflozin 10mg

Subjects take the investigational products once a day for 24 weeks.

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Woo-je Lee · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2022-09-19
Completion
2023-03-10

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885712 on ClinicalTrials.gov