NCT05566028

The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients with Type 2 Diabetes

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of D150, D745 and D759 Combination Therapy in Pateints with Type 2 Diabetes Inadequately Controlled with D150 Plus D759

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.

Detailed description

The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	D745 formulation I	QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
DRUG	D745 formulation II	QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
DRUG	D745 Placebo	QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Timeline

• Start date: 2022-10-12
• Primary completion: 2024-01-10
• Completion: 2024-07-23
• First posted: 2022-10-04
• Last updated: 2024-12-10

Locations

1 site across 1 country: South Korea