Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

Phase 1

Terminated

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT03332836
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-25
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Primary Completion: 2019-01-30
• Study Completion: 2020-09-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	1 month	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

Name	Time	Method
Cmax of HM12460A	1 month	- Maximum concentration of HM12460A over the entire dosing period
AUC of HM12460A	1 month	- Area Under the Curve of HM12460A over the entire dosing period

Trial Locations

Locations (1)

Hanmi Investigative Site; 🇺🇸 Chula Vista, California, United States