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NCT Number: NCT06647550

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

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Anam Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Sin-Gon Kim, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HD-6277 100mg

Drug

PO, QD

HD-6277 50mg

Drug

PO, QD

HD-6277 25mg

Drug

PO, QD

Placebo

Drug

PO, QD

Primary outcomes

  1. change in HbA1c at weeks 12 from baseline

    Time frame: at weeks 12 from baseline

    change in HbA1c at weeks 12 from baseline

Secondary outcomes

  1. change in HbA1c at weeks 6 from baseline

    Time frame: at weeks 6 from baseline

    change in HbA1c at weeks 6 from baseline

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sin Gon Kim Korea University Anam Hospital, PhD

CONTACT

[email protected]

+82 1577-0083

Sponsors and collaborators

Lead sponsor

Hyundai Pharm

Industry

Registry information

Official study title

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

Acronym: HDNO-1605

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 18, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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