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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: HD-6277; Drug: Placebo

• Registration Number: NCT05666128
• Lead Sponsor: Hyundai Pharm

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-17
• Study First Submitted: 2022-12-18
• Study First Submitted QC: 2022-12-23
• Study First Posted: 2022-12-27
• Primary Completion: 2023-06-28
• Study Completion: 2023-07-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HD-6277 100mg	HD-6277	-
HD-6277 50mg	HD-6277	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c(%) at weeks 12 from baseline	at weeks 12 from baseline

Trial Locations

Locations (1)

Included Severance Hospital, 10 sites; 🇰🇷 Seoul, Korea, Republic of