Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

A Phase 1, Multiple Ascending Dose, Glucose Clamp Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM12460A Compared to Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03332836

Enrollment

Registered

2017-11-06

Start date

2017-10-25

Completion date

2020-09-30

Last updated

2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Interventions

BIOLOGICALHM12460A

HM12460A is a long-acting insulin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events	1 month	An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products.

Secondary

Measure	Time frame	Description
Cmax of HM12460A	1 month	\- Maximum concentration of HM12460A over the entire dosing period
AUC of HM12460A	1 month	\- Area Under the Curve of HM12460A over the entire dosing period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026