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NCT05666128 Clinical Trial

Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05666128
Other study ID # HT-006-02
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 17, 2022
Est. completion date July 20, 2023

Study information
Verified date December 2022
Source Hyundai Pharm
Contact Seong Jin Park
Phone 82-2-2600-3949
Email spark@hdpharm.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 113
Est. completion date July 20, 2023
Est. primary completion date April 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HD-6277
HD-6277 Oral tablet 100mg
• HD-6277
HD-6277 Oral tablet 50mg
• Placebo
Oral tablet

Locations
Country Name City State
Korea, Republic of Included Severance Hospital, 10 sites Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hyundai Pharm

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c(%) 12 weeks
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