Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus

A Phase 1, Multiple Ascending Dose Glucose Clamp Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470 in Comparison to Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes Mellitus

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03332849

Enrollment

Registered

2017-11-06

Start date

2015-07-28

Completion date

2018-04-30

Last updated

2017-11-06

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

Conditions

Type1 Diabetes Mellitus, Type2 Diabetes Mellitus

Brief summary

This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus

Interventions

BIOLOGICALHM12470

HM12470 is a long-acting insulin analogue

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

* T1DM or T2DM * Female subjects must be non-pregnant and non-lactating

Exclusion criteria

* 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 HM12470	1 month	\- Maximum concentration of HM12470 over the entire dosing period
AUC of HM12470	1 month	\- Area Under the Curve of HM12470 over the entire dosing period

Countries

United States

Outcome results

None listed

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