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Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03332836
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Biological: HM12460A Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

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


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: November 6, 2017    Key Record Dates
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