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

JW Pharmaceutical200 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Type 2 Diabetes Mellitus

Interventions

Treatment Period(JW0201)DRUG

JW0201: 200mg/day For 24 weeks(PO, BID) C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)

Treatment Period(Placebo)DRUG

C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)

Extension Period(JW0201)DRUG

JW0201: 200mg/day For 28 weeks(PO, BID) C2022: ≥1,000 mg/day for 28 Weeks(PO, BID) C2203: 25 mg/day for 28 Weeks(PO, BID)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes Mellitus Exclusion Criteria: * Type 1 Diabetes Mellitus * The subject not meet the specified HbA1c and FPG

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

HbA1c (24 Weeks) lowering effect

change in HbA1c

Time frame: 24 Weeks

Secondary Outcomes

HbA1c lowering effect

change in HbA1c

Time frame: 6, 12, 18, 32, 40, 52 Weeks

Data from ClinicalTrials.gov

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