NCT04885712

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-05-28
• Primary completion: 2022-09-19
• Completion: 2023-03-10
• First posted: 2021-05-13
• Last updated: 2023-05-24

Locations

1 site across 1 country: South Korea