Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

Phase 1TerminatedNCT03332836

Hanmi Pharmaceutical Company Limited21 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

HM12460ABIOLOGICAL

HM12460A is a long-acting insulin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hanmi Investigative Site

Chula Vista, California, United States

Outcomes

Primary Outcomes

Number of participants with adverse events

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.

Time frame: 1 month

Secondary Outcomes

Cmax of HM12460A

\- Maximum concentration of HM12460A over the entire dosing period

Time frame: 1 month

AUC of HM12460A

\- Area Under the Curve of HM12460A over the entire dosing period

Time frame: 1 month

Data from ClinicalTrials.gov

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