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Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

This study is currently recruiting participants.
Verified November 2017 by Hanmi Pharmaceutical Company Limited
Sponsor:
ClinicalTrials.gov Identifier:
NCT03332836
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  Purpose
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.

Condition Intervention Phase
Type 2 Diabetes Mellitus Biological: HM12460A Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Cmax of HM12460A [ Time Frame: 1 month ]
    - Maximum concentration of HM12460A over the entire dosing period

  • AUC of HM12460A [ Time Frame: 1 month ]
    - Area Under the Curve of HM12460A over the entire dosing period


Estimated Enrollment: 48
Actual Study Start Date: October 25, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332836


Contacts
Contact: Hanmi Pharmaceuticals +82-2-410-9114 clinical4@hanmi.co.kr

Locations
United States, California
Hanmi Investigative Site Recruiting
Chula Vista, California, United States, 91911
Contact: Hanmi Pharmaceuticals       clinical4@hanmi.co.kr   
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03332836     History of Changes
Other Study ID Numbers: HM-INS-102
First Submitted: October 26, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases