To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HD-6277 100mg, HD-6277 50mg, HD-6277 25mg, Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 19 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
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.
Interventions
- Drug HD-6277 100mg
PO, QD - Drug HD-6277 50mg
PO, QD - Drug HD-6277 25mg
PO, QD - Drug Placebo
PO, QD
Primary outcome measures
- change in HbA1c at weeks 12 from baseline [Time frame: at weeks 12 from baseline]
Secondary outcome measures (4)
- change in HbA1c at weeks 6 from baseline [Time frame: 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 6.5% at weeks 12 [Time frame: at weeks 12]
- change in Glycoalbumin at weeks 6 and 12 from baseline [Time frame: at weeks 6 and 12 from baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Korea University Anam Hospital — Seoul
Identifiers
NCT: NCT06647550 · HT-006-04