Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.
Detailed description
This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.
Interventions
BIOLOGICALHM12470
Single dose subcutaneous administration ranging from a very low dose to high dose
BIOLOGICALActive comparator
Single dose subcutaneous administration of active comparator
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
for T1DM: * T2DM more than 12 monthM * Age ≥18 and ≤70 years * Body mass index between 18.0 and 35.0 kg/m2 inclusive. * Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. * Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug. * Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Inclusion Criteria for T2DM: * T1DM more than 12 monthM * Age ≥18 and ≤70 years * Body mass index between 18.0 and 30.0 kg/m2 inclusive. * Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. * Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug. * Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
Exclusion criteria
* A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator * Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis * pregnant or lactating women * participation in an investigational study within 30 days prior to dosing * Clinically significant abnormal ECG at screening, as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment emergent adverse events | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration(Cmax) of HM12470 following a single dose | 1 month | Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay |
| Area under the concentration-time curve (AUC) of HM12470 following a single dose | 1 month | Pharmacokinetic properties of HM12470 following a single dose will be assessed in plasma using a validated assay |
Countries
South Korea
Outcome results
None listed