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OpenTrials
Completed

NCT Number: NCT05814393

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kangbuk Samsung Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes Mellitus

Exclusion criteria

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

Treatment and study plan

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)

Other names: JW0201+C2022+C2203

Treatment Period(Placebo)

Drug

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

Other names: C2022+C2203

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)

Other names: JW0201+C2022+C2203

Primary outcomes

  1. HbA1c (24 Weeks) lowering effect

    Time frame: 24 Weeks

    change in HbA1c

Secondary outcomes

  1. HbA1c lowering effect

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

    change in HbA1c

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 14, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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