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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

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

T1DM: 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

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

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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