Evaluating a new treatment for type 2 diabetes
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 C2204
PHASE3 · JW Pharmaceutical · NCT05814406
This study is testing a new diabetes medication called JW0201 to see if it can help people with type 2 diabetes better control their blood sugar when their current treatments aren't working well enough.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | JW Pharmaceutical (industry) |
| Locations | 1 site (Gwangju) |
| Trial ID | NCT05814406 on ClinicalTrials.gov |
What this trial studies
This phase 3 clinical trial is designed to assess the efficacy and safety of JW0201 when added to the treatment regimen of patients with type 2 diabetes mellitus who are not achieving adequate glycemic control with existing medications C2202 and C2204. The study employs a multicenter, randomized, double-blind, placebo-controlled, parallel design to ensure robust results. Participants will receive either the investigational drug JW0201 or a placebo to determine the treatment's effectiveness in managing blood sugar levels.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with type 2 diabetes mellitus who are experiencing inadequate glycemic control.
Not a fit: Patients with type 1 diabetes mellitus or those who do not meet the specified HbA1c and fasting plasma glucose criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide improved glycemic control for patients with type 2 diabetes who are currently not well-managed on their existing medications.
How similar studies have performed: Other studies have shown promise in similar approaches for managing type 2 diabetes, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 Diabetes Mellitus Exclusion Criteria: * Type 1 Diabetes Mellitus * The subject not meet the specified HbA1c and FPG
Where this trial is running
Gwangju
- Chosun University Hospital — Gwangju, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Sangyong Kim — Chosun University Hospital
- Study coordinator: Daegeun Song
- Email: 20190122@jw-group.co.kr
- Phone: +82-2-840-6792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes Mellitus, Diabetes Mellitus