NCT03332849

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2015

Completed
2.2 years 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

October 26, 2017

Last Update Submit

November 1, 2017

Conditions

Type1 Diabetes MellitusType2 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 HM12470

    1 month

  • AUC of HM12470

    1 month

Study Arms (4)

Cohort 1

EXPERIMENTAL

T1DM: Multiple dose subcutaneous administration

Biological: HM12470

Cohort 2

EXPERIMENTAL

T1DM: Multiple dose subcutaneous administration

Biological: HM12470

Cohort 3

EXPERIMENTAL

T2DM: Multiple dose subcutaneous administration

Biological: HM12470

Cohort 4

EXPERIMENTAL

T2DM: Multiple dose subcutaneous administration

Biological: HM12470

Interventions

HM12470BIOLOGICAL

HM12470 is a long-acting insulin analogue

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

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

July 28, 2015

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(1)