A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM

PHASE1CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

August 29, 2018

Primary Completion Date

May 7, 2020

Study Completion Date

May 7, 2020

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

DA-1241

"\[Part1\] Administration once daily for 28 days; Dose strength for each cohort (Cohort 1, 2 and 3) is planned as 50mg, 100mg and 200mg, respectively.~\[Part2\] Administration once daily for 56 days; Dose strength for each cohort (Cohort 4, 5 and 6) is planned as 25mg, 50mg and 100mg, respectively.~(Dose escalation and dose level decisions for subsequent cohorts will be made via interim dose escalation review meetings.)"

DRUG

Placebo

\[Part1\] Administration once daily for 28 days. \[Part2\] Administration once daily for 56 days.

DRUG

Sitagliptin

\[Part2\] Administration of Sitagliptin 100mg once daily for 56 days.

Trial Locations (4)

27265

High Point Clinical Trials Center, High Point

33014

Clinical Pharmacology of Miami, Miami

91911

Clinical Site, Chula Vista

98057

Rainier Clinical Research Center, Renton

All Listed Sponsors
lead

Dong-A ST Co., Ltd.

INDUSTRY

NCT03646721 - A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM | Biotech Hunter | Biotech Hunter