Evaluating a new combination therapy for type 2 diabetes patients
A Observational Study to Evaluate Effectiveness, Safety of Triple Combination Therapy of Zemidapa and Metformin in Patients With Type 2 DM Who Received Double or Triple Combination Therapy Including DPP4-inhibitor Other Than Gemigliptin
This study is testing a new combination treatment with Zemidapa Tab. and Metformin to see if it helps people with type 2 diabetes who are already on other diabetes medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | LG Chem Industry-sponsored |
| Locations | 1 site (Hwasun, Jeollanam-do) |
| Trial ID | NCT06495281 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and safety of a triple combination therapy involving Zemidapa Tab. and Metformin in patients with type 2 diabetes mellitus. Participants will be those already receiving either double or triple combination therapies that include Metformin and a DPP-4 inhibitor. The study will monitor patient outcomes and safety profiles as they begin treatment with Zemidapa Tab. for the first time, under the supervision of their attending physician.
Who should consider this trial
Good fit: Ideal candidates are type 2 diabetes patients currently on specific combination therapies that include Metformin.
Not a fit: Patients who are contraindicated for Zemidapa Tab. or have participated in another clinical study within the last 12 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for managing type 2 diabetes mellitus.
How similar studies have performed: While this approach is not widely tested, similar combination therapies have shown promise in managing type 2 diabetes in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * type 2 DM Patients who are receiving one of the following three therapies during which the patients are prescribed with Zemidapa Tab. for the first time at the discretion of the attending physician: 1. Double combination therapy (Metformin and a DPP-4 inhibitor other than Gemigliptin) 2. Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and a SGLT-2 inhibitor) 3. Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and Sulfonylurea \[SU\]) * patients with HbA1c results and who signed the written consent form Exclusion Criteria: - Patients contraindicated for the approved use of Zemidapa Tab. or have participated in another clinical study within 12 weeks
Where this trial is running
Hwasun, Jeollanam-do
- Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Study Lead
- Email: lgclinical@lgchem.com
- Phone: 82-2-6987-4156
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.