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

Hyundai Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: HD-6277; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05666128

HT-006-02

Details and patient eligibility

About

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

Enrollment: 112 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 3 patient groups, including a placebo group

HD-6277 100mg

Experimental group

Treatment:

Drug: HD-6277

Drug: HD-6277

HD-6277 50mg

Experimental group

Treatment:

Drug: HD-6277

Drug: HD-6277

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo