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NCT03332836 Clinical Trial

Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03332836
Other study ID # HM-INS-102
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date October 25, 2017
Est. completion date September 30, 2020

Study information
Verified date March 2021
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 2 Diabetes Mellitus.

Recruitment information / eligibility
Status Terminated
Enrollment 21
Est. completion date September 30, 2020
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• HM12460A
HM12460A is a long-acting insulin

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 HM12460A - Maximum concentration of HM12460A over the entire dosing period 1 month
Secondary AUC of HM12460A - Area Under the Curve of HM12460A over the entire dosing period 1 month
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