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Last Updated: February 16, 2020

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CLINICAL TRIALS PROFILE FOR EVOGLIPTIN


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Clinical Trials for Evogliptin

Trial ID Title Status Sponsor Phase Summary
NCT02167061 A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Completed Dong-A ST Co., Ltd. Phase 1 This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers
NCT02214693 PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients Completed Dong-A ST Co., Ltd. Phase 1 This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.
NCT02375139 A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers Completed Dong-A ST Co., Ltd. Phase 1 This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).
NCT02587975 Effect of Evogliptin on Bone Metabolism in Human Recruiting DongGuk University Phase 4 This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
NCT02689362 Evogliptin in Type 2 Diabetes Mellitus (EVOLUTION: EVOgLiptina no Diabetes Mellitus TIpO 2) Not yet recruiting Eurofarma Laboratorios S.A. Phase 2 This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel treatment groups, with active control, will be performed in Brazilian study sites under the sponsorship of Eurofarma Laboratórios S.A.. The enrollment for participants in the study will start after the relevant ethical and regulatory approvals and will have an estimated duration of 18 months. One hundred and forty-four participants with T2DM according to the criteria of ADA who consent to participation in the study by signing the Informed Consent Form (ICF) will be enrolled in the study. In order to be enrolled, the patients must meet all the inclusion criteria and none of the exclusion criteria. The eligible participants will be randomized 1:1:1:1 to receive evogliptin (EVO) at the doses of 2.5 mg/day (N = 36), 5.0 mg/day (N = 36) or 10 mg/day (N = 36) or sitagliptin (SITA) at the dose of 100 mg/day (N = 36), as a single daily dose, for 12 weeks.
NCT02753803 Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg Not yet recruiting Dong-A ST Co., Ltd. Phase 1 A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects
NCT02754219 Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction Not yet recruiting Dong-A ST Co., Ltd. Phase 1 The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Evogliptin

Condition Name

Condition Name for
Intervention Trials
Type2 Diabetes 5
Type 2 Diabetes Mellitus 4
Diabetes Mellitus, Type 2 2
Liver Dysfunction 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Diabetes Mellitus, Type 2 10
Diabetes Mellitus 10
Liver Diseases 2
Renal Insufficiency 2
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Clinical Trial Locations for Evogliptin

Trials by Country

Trials by Country for
Location Trials
Korea, Republic of 13
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Clinical Trial Progress for Evogliptin

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 7
Completed 6
Recruiting 2
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Clinical Trial Sponsors for Evogliptin

Sponsor Name

Sponsor Name for
Sponsor Trials
Dong-A ST Co., Ltd. 13
DongGuk University 1
Samsung Medical Center 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 14
Other 2
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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
AstraZeneca
McKesson
Moodys
Merck

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