NCT03332836

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

October 26, 2017

Last Update Submit

March 30, 2021

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (2)

  • Cmax of HM12460A

    1 month

  • AUC of HM12460A

    1 month

Study Arms (3)

Cohort 1

EXPERIMENTAL

Single dose subcutaneous administration (Dose A)

Biological: HM12460A

Cohort 2

EXPERIMENTAL

Single dose subcutaneous administration (Dose B)

Biological: HM12460A

Cohort 3

EXPERIMENTAL

Single dose subcutaneous administration (Dose C)

Biological: HM12460A

Interventions

HM12460ABIOLOGICAL

HM12460A is a long-acting insulin

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Investigative Site

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 6, 2017

Study Start

October 25, 2017

Primary Completion

January 30, 2019

Study Completion

September 30, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

US(1)