Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, 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
1 other identifier
interventional
112
1 country
1
Brief Summary
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2022
CompletedFirst Submitted
Initial submission to the registry
December 18, 2022
CompletedFirst Posted
Study publicly available on registry
December 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2023
CompletedOctober 18, 2024
October 1, 2024
1 year
December 18, 2022
October 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c(%) at weeks 12 from baseline
at weeks 12 from baseline
Study Arms (3)
HD-6277 100mg
EXPERIMENTALHD-6277 50mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 6 weeks prior to screening.
You may not qualify if:
- Type 1 diabetes or another immune-mediated diabetes syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hyundai Pharmlead
Study Sites (1)
Included Severance Hospital, 10 sites
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2022
First Posted
December 27, 2022
Study Start
June 17, 2022
Primary Completion
June 28, 2023
Study Completion
July 28, 2023
Last Updated
October 18, 2024
Record last verified: 2024-10