NCT06141980

Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus

A Multi-center, phase3, Open-label Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Gemigliptin

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial. The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Detailed description

The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs. At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial. The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	DWP16001 0.3 mg	DWP16001 0.3mg, Tablets, Orally, Once daily

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-11-21
• Last updated: 2023-11-21