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NCT03332849 Clinical Trial

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

Type2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03332849
Other study ID # HM-INS115-103
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received October 26, 2017
Last updated November 1, 2017
Start date July 28, 2015
Est. completion date April 30, 2018

Study information
Verified date November 2017
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• HM12470
HM12470 is a long-acting insulin analogue

Locations
Country Name City State
United States Hanmi Investigative Site Chula Vista California

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 month
Secondary Cmax of HM12470 - Maximum concentration of HM12470 over the entire dosing period 1 month
Secondary AUC of HM12470 - Area Under the Curve of HM12470 over the entire dosing period 1 month
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