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

Phase 4

• Conditions: type 2 diabetes

• Registration Number: JPRN-jRCT1080223427
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 219

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline (Week 0) in total score for all question items in the DTR-QOL Questionnaire at Week 12.<br>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across four subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.<br>Time frame; Week 0 up to Week 12