Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus
Primary Purpose
Type1 Diabetes Mellitus, Type2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HM12470
Sponsored by
About this trial
This is an interventional treatment trial for Type1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- T1DM or T2DM
- Female subjects must be non-pregnant and non-lactating
Exclusion Criteria:
- 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 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
T1DM: Multiple dose subcutaneous administration
T1DM: Multiple dose subcutaneous administration
T2DM: Multiple dose subcutaneous administration
T2DM: Multiple dose subcutaneous administration
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 HM12470
- Maximum concentration of HM12470 over the entire dosing period
AUC of HM12470
- Area Under the Curve of HM12470 over the entire dosing period
Full Information
NCT ID
NCT03332849
First Posted
October 26, 2017
Last Updated
November 1, 2017
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT03332849
Brief Title
Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus
Official Title
A Phase 1, Multiple Ascending Dose Glucose Clamp Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470 in Comparison to Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2015 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)
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 1 and Type 2 diabetes mellitus
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes Mellitus, Type2 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
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
T1DM: Multiple dose subcutaneous administration
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
T1DM: Multiple dose subcutaneous administration
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
T2DM: Multiple dose subcutaneous administration
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
T2DM: Multiple dose subcutaneous administration
Intervention Type
Biological
Intervention Name(s)
HM12470
Intervention Description
HM12470 is a long-acting insulin analogue
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 HM12470
Description
- Maximum concentration of HM12470 over the entire dosing period
Time Frame
1 month
Title
AUC of HM12470
Description
- Area Under the Curve of HM12470 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:
T1DM or T2DM
Female subjects must be non-pregnant and non-lactating
Exclusion Criteria:
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 HM12470 in Type 1 and Type 2 Diabetes Mellitus
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