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

NCT ID: NCT05666128

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2023-07-28

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HD-6277 100mg

Group Type EXPERIMENTAL

HD-6277

Intervention Type DRUG

HD-6277 100mg

HD-6277 50mg

Group Type EXPERIMENTAL

HD-6277

Intervention Type DRUG

HD-6277 50mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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HD-6277

HD-6277 100mg

Intervention Type DRUG

HD-6277

HD-6277 50mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hyundai Pharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Included Severance Hospital, 10 sites

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HT-006-02

Identifier Type: -

Identifier Source: org_study_id

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