Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
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
DRUGHD-6277 50mg
PO, QD
DRUGHD-6277 25mg
PO, QD
DRUGPlacebo
PO, QD
DRUGHD-6277 100mg
PO, QD
Sponsors
Hyundai Pharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in HbA1c at weeks 12 from baseline | at weeks 12 from baseline | change in HbA1c at weeks 12 from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of subjects with HbA1c level below 7.0% at weeks 12 | at weeks 12 | percentage of subjects with HbA1c level below 7.0% at weeks 12 |
| percentage of subjects with HbA1c level below 6.5% at weeks 12 | at weeks 12 | percentage of subjects with HbA1c level below 6.5% at weeks 12 |
| change in HbA1c at weeks 6 from baseline | at weeks 6 from baseline | change in HbA1c at weeks 6 from baseline |
| change in Glycoalbumin at weeks 6 and 12 from baseline | at weeks 6 and 12 from baseline | change in Glycoalbumin at weeks 6 and 12 from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in GA/HbA1c 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 |
| change in body weight at weeks 6 and 12 from baseline | at weeks 6 and 12 from baseline | change in body weight at weeks 6 and 12 from baseline |
Countries
South Korea
Contacts
Primary ContactSin Gon Kim Korea University Anam Hospital, PhD
Outcome results
None listed