Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: DW1026C1; Drug: DW1026C2; Drug: DW1026S

• Registration Number: NCT07076056
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-27
• Primary Completion: 2023-12-04
• Study Completion: 2024-06-19
• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-13
• Last Update Submitted: 2025-07-13
• Study First Posted: 2025-07-21
• Last Update Posted: 2025-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Patients who are diagnosed with Type2 Diabetes
• 19 ≤ Age ≤ 85
• 7.0% ≤ HbA1c ≤ 10.5%

Exclusion Criteria

• Patients with a history of acute pancreatitis
• Patients with a history of pre-diabetic coma
• Patients with a history of diagnosis of malignant tumors within 5 years prior to visit 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DW1026C1 & DW1026C2 placebo & DW1026S placebo	DW1026C1	-
DW1026C1 placebo & DW1026C2 & DW1026S placebo	DW1026C2	-
DW1026C1 placebo & DW1026C2 placebo & DW1026S	DW1026S	-

Primary Outcome Measures

Name	Time	Method
% change of HbA1c	24 weeks	% change of HbA1c in week 24 from baseline

Trial Locations

Locations (1)

Yeouido St. Mary's Hospital The Catholic University; 🇰🇷 Seoul, Korea, Republic of