To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise (HDNO-1605)

Hyundai Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: HD-6277 50mg; Drug: HD-6277 25mg; Drug: HD-6277 100mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06647550

HT-006-04

Details and patient eligibility

About

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, 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

Full description

This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.

This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.

Enrollment: 160 estimated 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 8 weeks prior to screening.

Exclusion criteria

• Type 1 diabetes or another immune-mediated diabetes syndrome
• BMI: > 40 kg/m2
• C-peptide: < 0.5ng/mL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

HD-6277 100mg tab

Experimental group

Description:

Oral tablet

Treatment:

Drug: HD-6277 100mg

HD-6277 50mg tab

Experimental group

Description:

Oral tablet

Treatment:

Drug: HD-6277 50mg

HD-6277 25mg tab

Experimental group

Description:

Oral tablet

Treatment:

Drug: HD-6277 25mg

Placebo

Placebo Comparator group

Description:

Oral tablet

Treatment:

Drug: Placebo