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Clinical Trial Details

Trial ID: L5063
Source ID: NCT03646721
Associated Drug: Da-1241
Title: A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: DA-1241|DRUG: Placebo|DRUG: Sitagliptin
Outcome Measures: Primary: 12-lead ECGs, Change from baseline in QTcF (msec), Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively|Blood pressure, Change from baseline in blood pressure (mmHg), Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively|Heart rate, Change from baseline in heart rate (bpm), Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively|Body temperature, Change from baseline in oral body temperature (°C), Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively|Respiratory rate, Change from baseline in respiratory rate (bpm), Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively|Physical examination, Incidence and severity of clinical findings on physical examination, Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively|Clinical laboratory testing, Incidence and severity of clinical laboratory abnormality, Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively|Adverse event, Incidence and severity of adverse event, Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively | Secondary: Maximum concentration of DA-1241 (Cmax), Through the treatment period; 24 hours|Time of maximum plasma DA-1241 concentration (Tmax), Through the treatment period; 24 hours|Area under the concentration-time curve (AUC), Through the treatment period; 9 days|Apparent terminal elimination half-life (t½), Through the treatment period; 9 days|Apparent total systemic clearance after oral administration (CL/F), Through the treatment period; 9 days|Apparent volume of distribution (Vz/F), Through the treatment period; 9 days|Accumulation ratio (Last dosing day AUCtau / First dosing day AUCtau), Through the treatment period; 9 days|Amount of DA-1241 excreted unchanged in the urine in each collection interval(Ae), Through the treatment period; 7 days|Cumulative amount of DA-1241 excreted unchanged in the urine (Cum Ae), Through the treatment period; 7 days|Percentage fraction of DA-1241 excreted unchanged in the urine in each collection interval(Fe), Through the treatment period; 7 days|Cumulative percentage fraction of DA-1241 excreted unchanged in the urine (Cum Fe), Through the treatment period; 7 days|Renal clearance (CLR), Through the treatment period; 7 days|Fasting Plasma Glucose (FPG), Through the treatment period; 62 days|2h-Postprandial glucose, Through the treatment period; 56 days|Area under the measurements versus (vs) time curve(AUE), Through the treatment period; 56 days|Incremental AUEs after meal (iAUE), Through the treatment period; 56 days|Weighted mean glucose (WMG), Through the treatment period; 56 days|Incremental WMG (iWMG), Through the treatment period; 56 days|Fasting Insulin, Through the treatment period; 56 days|Glycated albumin, Through the treatment period; 56 days|HbA1c, Through the treatment period; 56 days | Other: Assessment of key metabolite(s) of DA-1241, Key metabolite(s) of DA-1241 will be assessed in blood and urine., Through the treatment period; 41 days
Sponsor/Collaborators: Sponsor: Dong-A ST Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 108
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-08-29
Completion Date: 2020-05-07
Results First Posted:
Last Update Posted: 2021-02-11
Locations: Clinical Site, Chula Vista, California, 91911, United States|Clinical Pharmacology of Miami, Miami, Florida, 33014, United States|High Point Clinical Trials Center, High Point, North Carolina, 27265, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States
URL: https://clinicaltrials.gov/show/NCT03646721