Study of the QOL evaluation of Trelagliptin in patient with type 2 diabetes mellitus

TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 219 人开始时间: 2017年1月5日最近更新: 2023年10月17日

试验速览

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•1.Participants diagnosed as type 2 diabetes.
•2.Participants with a stable diet and exercise therapy only for at least 12 weeks prior to the start of the screening period.
•3.Participants who require a DPP-4 inhibitor treatment.
•4.Participants with HbA1c >=6.5 % and <10.0 % at the start of the screening period.
•5.Participants who completed DTR-QOL questionnaire at the start of the screening period.
•6.Participants who have receive less than 2 types of medication for treatment of comorbidities (such as hypertension or dyslipidemia) at the start of the screening period (any number of daily doses).
•7.Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.
•8.Participants who can provide the written informed consent prior to the initiation of any study procedures.
•9.Participants aged >=20 years at the time of informed consent.
•10.Outpatient.

•1.Participants who are receiving any oral anti-diabetic medication for the treatment of type 2 diabetes at the start of the screening period.
•2.Participants diagnosed as type 1 diabetes.
•3.Participants with severe renal impairment or renal failure (e.g., eGFR <30 mL/min/1.73 m2 or on dialysis).
•4.Participants with serious heart disease or cerebrovascular disorder, or serious pancreatic, blood, or other disease.
•5.Participants with a history of gastrointestinal resection.
•6.Participant with a proliferative diabetic retinopathy.
•7.Participant with malignancy.
•8.Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
•9.Pregnant, lactating or postmenopausal women.
•10.Participants who may need to add or discontinue concomitant medication or change the dose during the study period.
•11.Participants who will require treatment with a prohibited concomitant medication during the study period.
•12.Participants participating in other clinical studies.
•13.Participants assessed ineligible in the study by the principal investigator or the investigator.

发起方

TAKEDA PHARMACEUTICAL COMPANY LTD.