Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Sponsor
Hyundai Pharm (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05666128
Collaborator
(none)
113
1
3
13.1
8.6
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
113 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jun 17, 2022
Anticipated Primary Completion Date
:
Apr 20, 2023
Anticipated Study Completion Date
:
Jul 20, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HD-6277 100mg tab
|
Drug: HD-6277
HD-6277 Oral tablet 100mg
|
| Experimental: HD-6277 50mg tab
|
Drug: HD-6277
HD-6277 Oral tablet 50mg
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Oral tablet
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c(%) [12 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Included Severance Hospital, 10 sites | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Hyundai Pharm
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hyundai Pharm
ClinicalTrials.gov Identifier:
NCT05666128
Other Study ID Numbers:
- HT-006-02
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 29, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: