Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

March 30, 2021 updated by: Hanmi Pharmaceutical Company Limited

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Hanmi Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
Single dose subcutaneous administration (Dose A)
Biological: HM12460A
HM12460A is a long-acting insulin
EXPERIMENTAL: Cohort 2
Single dose subcutaneous administration (Dose B)
Biological: HM12460A
HM12460A is a long-acting insulin
EXPERIMENTAL: Cohort 3
Single dose subcutaneous administration (Dose C)
Biological: HM12460A
HM12460A is a long-acting insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: 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.
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 25, 2017

Primary Completion (ACTUAL)

January 30, 2019

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (ACTUAL)

November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-INS-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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