Back to resultsMultiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HM12460A
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Hanmi Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Single dose subcutaneous administration (Dose A)
Single dose subcutaneous administration (Dose B)
Single dose subcutaneous administration (Dose C)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cmax of HM12460A
- Maximum concentration of HM12460A over the entire dosing period
AUC of HM12460A
- Area Under the Curve of HM12460A over the entire dosing period
Full Information
NCT ID
NCT03332836
First Posted
October 26, 2017
Last Updated
March 30, 2021
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT03332836
Brief Title
Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Sopnsor decision
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Single dose subcutaneous administration (Dose A)
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Single dose subcutaneous administration (Dose B)
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Single dose subcutaneous administration (Dose C)
Intervention Type
Biological
Intervention Name(s)
HM12460A
Intervention Description
HM12460A is a long-acting insulin
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Cmax of HM12460A
Description
- Maximum concentration of HM12460A over the entire dosing period
Time Frame
1 month
Title
AUC of HM12460A
Description
- Area Under the Curve of HM12460A over the entire dosing period
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hanmi Investigative Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus
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