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)

December 12, 2024 updated by: Hyundai Pharm

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sin Gon Kim Korea University Anam Hospital, PhD
  • Phone Number: +82 1577-0083
  • Email: k50367@korea.ac.kr

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral tablet
Drug: Placebo
PO, QD
Experimental: HD-6277 100mg tab
Oral tablet
Drug: HD-6277 100mg
PO, QD
Experimental: HD-6277 50mg tab
Oral tablet
Drug: HD-6277 50mg
PO, QD
Experimental: HD-6277 25mg tab
Oral tablet
Drug: HD-6277 25mg
PO, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in HbA1c at weeks 12 from baseline
Time Frame: at weeks 12 from baseline
change in HbA1c at weeks 12 from baseline
at weeks 12 from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in HbA1c at weeks 6 from baseline
Time Frame: at weeks 6 from baseline
change in HbA1c at weeks 6 from baseline
at weeks 6 from baseline
percentage of subjects with HbA1c level below 7.0% at weeks 12
Time Frame: at weeks 12
percentage of subjects with HbA1c level below 7.0% at weeks 12
at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12
Time Frame: at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12
at weeks 12
change in Glycoalbumin at weeks 6 and 12 from baseline
Time Frame: at weeks 6 and 12 from baseline
change in Glycoalbumin at weeks 6 and 12 from baseline
at weeks 6 and 12 from baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in body weight at weeks 6 and 12 from baseline
Time Frame: at weeks 6 and 12 from baseline
change in body weight at weeks 6 and 12 from baseline
at weeks 6 and 12 from baseline
change in GA/HbA1c at weeks 6 and 12 from baseline
Time Frame: at weeks 6 and 12 from baseline
change in GA/HbA1c at weeks 6 and 12 from baseline
at weeks 6 and 12 from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyundai Pharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT-006-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus (T2DM)

Clinical Trials on HD-6277 100mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe