A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:
• Patients ≥19 and ≤ 80 years of age at Visit 1 (Screening) in accordance with American Diabetes Association (ADA) guidelines
• Patients who had received a stable dose of Drug A for at least 8 weeks prior to Visit 2 (Run-in vis it).
• In case of antidiabetic concomitant medications, patients who have maintained up to 2 oral antidiabetic drugs \[OADs\]) without changing regimen/dose/dosage at least 8 weeks prior to Visit 2 (Run-in visit).
• Patients with FPG of \<270 mg/dL at Visit 1 (Screening) (FPG result at Visit 1 will use local laboratory results)
• Body Mass Index (BMI) 18.0-40.0 kg/m2.
Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Younghee Kim
2210285@daewoong.co.kr
82-10-5768-9733
Time Frame
Start Date: 2023-03-17
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 240
Treatments
Experimental: DWP16001
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Daewoong Pharmaceutical Co. LTD.