| Trial ID: | L4012 |
| Source ID: | NCT06647550
|
| Associated Drug: |
Hd-6277 100mg
|
| Title: |
To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
|
| Acronym: |
HDNO-1605
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: HD-6277 100mg|DRUG: HD-6277 50mg|DRUG: HD-6277 25mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: change in HbA1c at weeks 12 from baseline, change in HbA1c at weeks 12 from baseline, at weeks 12 from baseline | Secondary: change in HbA1c at weeks 6 from baseline, change in HbA1c at weeks 6 from baseline, at weeks 6 from baseline|percentage of subjects with HbA1c level below 7.0% at weeks 12, percentage of subjects with HbA1c level below 7.0% at weeks 12, at weeks 12|percentage of subjects with HbA1c level below 6.5% at weeks 12, percentage of subjects with HbA1c level below 6.5% at weeks 12, at weeks 12|change in Glycoalbumin at weeks 6 and 12 from baseline, change in Glycoalbumin at weeks 6 and 12 from baseline, at weeks 6 and 12 from baseline | Other: change in body weight at weeks 6 and 12 from baseline, change in body weight at weeks 6 and 12 from baseline, at weeks 6 and 12 from baseline|change in GA/HbA1c at weeks 6 and 12 from baseline, change in GA/HbA1c at weeks 6 and 12 from baseline, at weeks 6 and 12 from baseline
|
| Sponsor/Collaborators: |
Sponsor: Hyundai Pharm
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
160
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-12-12
|
| Completion Date: |
2026-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-13
|
| Locations: |
Korea University Anam Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06647550
|
