To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus

JW Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Extension Period(JW0201); Drug: Treatment Period(JW0201); Drug: Treatment Period(Placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05814393

JW22301

Details and patient eligibility

About

A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2203

Full description

A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study

Enrollment: 200 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes Mellitus

Exclusion criteria

• Type 1 Diabetes Mellitus
• The subject not meet the specified HbA1c and FPG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

JW0201+C2202+C2203

Experimental group

Description:

Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)

Treatment:

Drug: Treatment Period(JW0201)

Drug: Extension Period(JW0201)

C2202+C2203

Placebo Comparator group

Description:

Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)

Treatment:

Drug: Treatment Period(Placebo)

Drug: Extension Period(JW0201)