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Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus

NCT ID: NCT03332849

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-28

Study Completion Date

2018-04-30

Brief Summary

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This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus

Detailed Description

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Conditions

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Type1 Diabetes Mellitus Type2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

T1DM: Multiple dose subcutaneous administration

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

HM12470 is a long-acting insulin analogue

Cohort 2

T1DM: Multiple dose subcutaneous administration

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

HM12470 is a long-acting insulin analogue

Cohort 3

T2DM: Multiple dose subcutaneous administration

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

HM12470 is a long-acting insulin analogue

Cohort 4

T2DM: Multiple dose subcutaneous administration

Group Type EXPERIMENTAL

HM12470

Intervention Type BIOLOGICAL

HM12470 is a long-acting insulin analogue

Interventions

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HM12470

HM12470 is a long-acting insulin analogue

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanmi Investigative Site

Chula Vista, California, United States

Site Status

Countries

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United States

Other Identifiers

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HM-INS115-103

Identifier Type: -

Identifier Source: org_study_id