Back to resultsEfficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Primary Purpose
Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HD-6277
HD-6277
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Type 1 diabetes or another immune-mediated diabetes syndrome
Sites / Locations
- Included Severance Hospital, 10 sitesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
HD-6277 100mg tab
HD-6277 50mg tab
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1c(%)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05666128
Brief Title
Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
July 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hyundai Pharm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
113 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HD-6277 100mg tab
Arm Type
Experimental
Arm Title
HD-6277 50mg tab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HD-6277
Intervention Description
HD-6277 Oral tablet 100mg
Intervention Type
Drug
Intervention Name(s)
HD-6277
Intervention Description
HD-6277 Oral tablet 50mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Change in HbA1c(%)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Type 1 diabetes or another immune-mediated diabetes syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong Jin Park
Phone
82-2-2600-3949
Email
spark@hdpharm.co.kr
Facility Information:
Facility Name
Included Severance Hospital, 10 sites
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung Wan Lee
Phone
82-2-2228-1938
Email
BWANLEE@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
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