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

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: DW1026C1; Drug: DW1026S; Drug: DW1026C2

Study type: Interventional

Funder types: Industry

Identifiers

NCT07076056

DW1026-301

Details and patient eligibility

About

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

Enrollment: 230 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 3 patient groups, including a placebo group

DW1026C1 & DW1026C2 placebo & DW1026S placebo

Experimental group

Treatment:

Drug: DW1026C1

DW1026C1 placebo & DW1026C2 & DW1026S placebo

Experimental group

Treatment:

Drug: DW1026C2

DW1026C1 placebo & DW1026C2 placebo & DW1026S

Placebo Comparator group

Treatment:

Drug: DW1026S