type 2 diabetes
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =20 years at the time of informed consent. 10.Outpatient.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (Week 0) in total score for all question items in the DTR-QOL Questionnaire at Week 12. 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. Time frame; Week 0 up to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Total score for each factor provided through the DTR-QOL Questionnaire [Factor 1: Burden on social activities and daily activities] at each assessment time point Time frame; Week 0 and Week 12 Total score for each factor provided through the DTR-QOL Questionnaire [Factor 2: Anxiety and dissatisfaction with treatment] at each assessment time point Time frame; Week 0 and Week 12 Total score for each factor provided through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at each assessment time point Time frame; Week 0 and Week 12 Total score for each factor provided through the DTR-QOL Questionnaire [Factor 4: Treatment satisfaction] at each assessment time point Time frame; Week 0 and Week 12 Total score for all questions in the DTR-QOL Questionnaire at each assessment time point. Time frame; Week 0 and Week 12 Total score for questions about treatment satisfaction in the DTSQ at each assessment time point. The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences. Time frame; Week 0 and Week 12 Changes from Week 0 in the total scores for all questions in the DTR-QOL Questionnaire and the total scores for questions about treatment satisfaction DTSQ, stratified by the use of medication for treatment of comorbidities at Week 0 Time frame; From Week 0 up to Week 12 Changes from Week 0 in the total scores for all questions in the DTR-QOL Questionnaire and the total scores for questions about treatment satisfaction DTSQ, stratified by the number of daily doses, medication for treatment of comorbidities (=2 times) at Week 0 Time frame; From Week 0 up to Week 12 Changes from Week 0 in the total scores for all questions in the D | — |
Outcome results
None listed