Evaluating HD-6277 for Type 2 Diabetes Control
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
This study is testing a new medication called HD-6277 to see if it can help adults with Type 2 Diabetes better control their blood sugar when diet and exercise alone aren't enough.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Hyundai Pharm Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06647550 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial aims to assess the efficacy and safety of HD-6277 in adults who have inadequate control of Type 2 Diabetes Mellitus through diet and exercise alone. The study is designed as a multi-center, double-blind, randomized, placebo-controlled, parallel-group, dose-finding trial. Participants will receive different doses of HD-6277 or a placebo to determine the optimal dosage for improving diabetes management. The trial will monitor participants' blood sugar levels and overall health throughout the study period.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Type 2 Diabetes Mellitus who have an HbA1c level between 7.0% and 10.0% while on diet and exercise alone.
Not a fit: Patients with Type 1 diabetes, other immune-mediated diabetes syndromes, or a BMI greater than 40 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide better control of blood sugar levels for patients with Type 2 Diabetes Mellitus.
How similar studies have performed: Other studies have shown promise in using similar approaches for managing Type 2 Diabetes, but the specific efficacy of HD-6277 is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening. Exclusion Criteria: * Type 1 diabetes or another immune-mediated diabetes syndrome * BMI: \> 40 kg/m2 * C-peptide: \< 0.5ng/mL
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Sin Gon Kim Korea University Anam Hospital, PhD
- Email: k50367@korea.ac.kr
- Phone: +82 1577-0083
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.