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Clinical Trials/NCT05666128
NCT05666128
Completed
Phase 2

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

Hyundai Pharm1 site in 1 country112 target enrollmentJune 17, 2022

Overview

Phase
Phase 2
Intervention
HD-6277
Conditions
Type 2 Diabetes Mellitus
Sponsor
Hyundai Pharm
Enrollment
112
Locations
1
Primary Endpoint
Change in HbA1c(%) at weeks 12 from baseline
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
June 17, 2022
End Date
July 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hyundai Pharm
Responsible Party
Sponsor

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

Arms & Interventions

HD-6277 100mg

Intervention: HD-6277

HD-6277 50mg

Intervention: HD-6277

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in HbA1c(%) at weeks 12 from baseline

Time Frame: at weeks 12 from baseline

Study Sites (1)

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