Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

Hanmi Pharmaceutical

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Biological: HM12460A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03332836

HM-INS-102

Details and patient eligibility

About

This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Female subjects must be non-pregnant and non-lactating

Exclusion criteria

• Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis, as judged by the Investigator
• Pregnant or lactating women
• Participation in an investigational study within 30 days prior to dosing

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Single dose subcutaneous administration (Dose A)

Treatment:

Biological: HM12460A

Cohort 2

Experimental group

Description:

Single dose subcutaneous administration (Dose B)

Treatment:

Biological: HM12460A

Cohort 3

Experimental group

Description:

Single dose subcutaneous administration (Dose C)

Treatment:

Biological: HM12460A