Trial Outcomes & Findings for Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus (NCT NCT03014479)

Last Updated: 2023-12-22

Results Overview

DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

219 participants

Primary outcome timeframe

Baseline (Week 0), up to the end of study (Week 12)

Results posted on

2023-12-22

Participant Flow

Participants took part in the study at 25 investigative sites in Japan, from 18 February 2017 to 21 October 2017.

Participants with a historical diagnosis of type 2 diabetes mellitus on diet and exercise therapy only, were enrolled in 1 of 2 treatment groups (Trelagliptin once-weekly, or the Daily DPP-4 inhibitor once- or twice-daily (according to individual label instructions), orally, for up to 12 weeks).

Participant milestones

Participant milestones
Measure	Trelagliptin Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Overall Study STARTED	110	109
Overall Study COMPLETED	110	105
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Trelagliptin Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Overall Study Adverse Event	0	1
Overall Study Voluntary Withdrawal	0	2
Overall Study Unacceptable Inability of Site Visit	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.	Total n=218 Participants Total of all reporting groups
Age, Continuous	61.5 Years STANDARD_DEVIATION 8.96 • n=110 Participants	58.4 Years STANDARD_DEVIATION 10.01 • n=108 Participants	59.9 Years STANDARD_DEVIATION 9.60 • n=218 Participants
Sex: Female, Male Female	24 Participants n=110 Participants	26 Participants n=108 Participants	50 Participants n=218 Participants
Sex: Female, Male Male	86 Participants n=110 Participants	82 Participants n=108 Participants	168 Participants n=218 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	110 Participants n=110 Participants	108 Participants n=108 Participants	218 Participants n=218 Participants
Height	165.0 Centimeter (cm) STANDARD_DEVIATION 9.56 • n=110 Participants	165.6 Centimeter (cm) STANDARD_DEVIATION 9.29 • n=108 Participants	165.3 Centimeter (cm) STANDARD_DEVIATION 9.41 • n=218 Participants
Weight	67.57 Kilogram (kg) STANDARD_DEVIATION 11.917 • n=110 Participants	70.51 Kilogram (kg) STANDARD_DEVIATION 15.707 • n=108 Participants	69.03 Kilogram (kg) STANDARD_DEVIATION 13.969 • n=218 Participants
Body Mass Index (BMI)	24.72 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.224 • n=110 Participants	25.53 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.349 • n=108 Participants	25.12 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.836 • n=218 Participants
Smoking Classification Never smoked	48 Participants n=110 Participants	40 Participants n=108 Participants	88 Participants n=218 Participants
Smoking Classification Current smoker	24 Participants n=110 Participants	28 Participants n=108 Participants	52 Participants n=218 Participants
Smoking Classification Ex-smoker	38 Participants n=110 Participants	40 Participants n=108 Participants	78 Participants n=218 Participants
Alcohol Classification Yes	38 Participants n=110 Participants	36 Participants n=108 Participants	74 Participants n=218 Participants
Alcohol Classification No	72 Participants n=110 Participants	72 Participants n=108 Participants	144 Participants n=218 Participants
Duration of type 2 diabetes mellitus	6.45 Years STANDARD_DEVIATION 4.972 • n=110 Participants	6.39 Years STANDARD_DEVIATION 5.286 • n=108 Participants	6.42 Years STANDARD_DEVIATION 5.118 • n=218 Participants
Any Medication for Concurrent Condition Had Any Medication	50 Participants n=110 Participants	41 Participants n=108 Participants	91 Participants n=218 Participants
Any Medication for Concurrent Condition Had No Any Medication	60 Participants n=110 Participants	67 Participants n=108 Participants	127 Participants n=218 Participants
Number of Daily Doses of Medication (Concurrent Condition Medicine.) Less than (<) 2 Times	46 Participants n=50 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	39 Participants n=41 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	85 Participants n=91 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.
Number of Daily Doses of Medication (Concurrent Condition Medicine.) Greater than or Equal to (≥) 2 Times	4 Participants n=50 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	2 Participants n=41 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	6 Participants n=91 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.
Total Number of Daily Tablets (Concurrent Condition Medicine.) <2 Tablets	44 Participants n=50 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	38 Participants n=41 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	82 Participants n=91 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.
Total Number of Daily Tablets (Concurrent Condition Medicine.) ≥2 Tablets	6 Participants n=50 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	3 Participants n=41 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.	9 Participants n=91 Participants • The baseline characteristic was analyzed in participants who had any medication for concurrent condition.
Number of Doses of Drugs (Study drug.) Once a Week	110 Participants n=110 Participants	0 Participants n=108 Participants	110 Participants n=218 Participants
Number of Doses of Drugs (Study drug.) Once daily	0 Participants n=110 Participants	100 Participants n=108 Participants	100 Participants n=218 Participants
Number of Doses of Drugs (Study drug.) Twice daily	0 Participants n=110 Participants	8 Participants n=108 Participants	8 Participants n=218 Participants
Glycated hemoglobin A1c (HbA1c)	7.37 Percent STANDARD_DEVIATION 0.730 • n=110 Participants	7.37 Percent STANDARD_DEVIATION 0.624 • n=108 Participants	7.37 Percent STANDARD_DEVIATION 0.678 • n=218 Participants
DTR-QOL Total Score at Week-4	66.41 Units on a Scale STANDARD_DEVIATION 15.934 • n=110 Participants	66.37 Units on a Scale STANDARD_DEVIATION 14.725 • n=108 Participants	66.39 Units on a Scale STANDARD_DEVIATION 15.311 • n=218 Participants
DTR-QOL Total Score at Week 0	68.48 Units on a Scale STANDARD_DEVIATION 17.158 • n=110 Participants	68.86 Units on a Scale STANDARD_DEVIATION 16.240 • n=108 Participants	68.67 Units on a Scale STANDARD_DEVIATION 16.673 • n=218 Participants
DTR-QOL Total Score; Factor 1 at Week 0	73.31 Units on a Scale STANDARD_DEVIATION 20.934 • n=110 Participants	73.48 Units on a Scale STANDARD_DEVIATION 20.060 • n=108 Participants	73.39 Units on a Scale STANDARD_DEVIATION 20.459 • n=218 Participants
DTR-QOL Total Score; Factor 2 at Week 0	62.94 Units on a Scale STANDARD_DEVIATION 20.334 • n=110 Participants	65.10 Units on a Scale STANDARD_DEVIATION 19.725 • n=108 Participants	64.01 Units on a Scale STANDARD_DEVIATION 20.018 • n=218 Participants
DTR-QOL Total Score; Factor 3 at Week 0	79.13 Units on a Scale STANDARD_DEVIATION 24.721 • n=110 Participants	78.97 Units on a Scale STANDARD_DEVIATION 23.254 • n=108 Participants	79.05 Units on a Scale STANDARD_DEVIATION 23.950 • n=218 Participants
DTR-QOL Total Score; Factor 4 at Week 0	53.22 Units on a Scale STANDARD_DEVIATION 16.539 • n=110 Participants	51.27 Units on a Scale STANDARD_DEVIATION 16.347 • n=108 Participants	52.26 Units on a Scale STANDARD_DEVIATION 16.435 • n=218 Participants
DTSQ Total score	22.31 Units on a Scale STANDARD_DEVIATION 5.444 • n=108 Participants • The number analyzed is the number of participants with data available for analysis.	21.56 Units on a Scale STANDARD_DEVIATION 5.679 • n=108 Participants • The number analyzed is the number of participants with data available for analysis.	21.94 Units on a Scale STANDARD_DEVIATION 5.562 • n=216 Participants • The number analyzed is the number of participants with data available for analysis.

PRIMARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study	8.72 Units on a Scale Standard Deviation 16.162	6.35 Units on a Scale Standard Deviation 14.093

SECONDARY outcome

Timeframe: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in 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 Week 4	11.24 Units on a Scale Standard Deviation 18.200	7.83 Units on a Scale Standard Deviation 19.426
Change From Baseline in 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 Week 12	10.98 Units on a Scale Standard Deviation 20.116	9.12 Units on a Scale Standard Deviation 18.560
Change From Baseline in 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 End of Study	10.79 Units on a Scale Standard Deviation 20.126	8.92 Units on a Scale Standard Deviation 19.048

SECONDARY outcome

Timeframe: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point Week 4	5.18 Units on a Scale Standard Deviation 14.925	0.39 Units on a Scale Standard Deviation 13.769
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point Week 12	5.94 Units on a Scale Standard Deviation 18.577	2.18 Units on a Scale Standard Deviation 17.498
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point End of Study	6.23 Units on a Scale Standard Deviation 18.735	2.10 Units on a Scale Standard Deviation 17.315

SECONDARY outcome

Timeframe: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point Week 4	6.15 Units on a Scale Standard Deviation 23.155	4.87 Units on a Scale Standard Deviation 22.298
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point Week 12	5.85 Units on a Scale Standard Deviation 22.837	7.38 Units on a Scale Standard Deviation 21.224
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point End of Study	6.06 Units on a Scale Standard Deviation 22.840	6.67 Units on a Scale Standard Deviation 21.586

SECONDARY outcome

Timeframe: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point Week 4	5.24 Units on a Scale Standard Deviation 22.254	3.85 Units on a Scale Standard Deviation 17.143
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point Week 12	8.53 Units on a Scale Standard Deviation 23.607	6.71 Units on a Scale Standard Deviation 18.431
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point End of Study	8.86 Units on a Scale Standard Deviation 23.806	6.17 Units on a Scale Standard Deviation 18.507

SECONDARY outcome

Timeframe: Baseline (Week 0), up to Week 4, 12

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point Week 4	8.04 Units on a Scale Standard Deviation 13.111	4.82 Units on a Scale Standard Deviation 12.776
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point Week 12	8.58 Units on a Scale Standard Deviation 16.280	6.63 Units on a Scale Standard Deviation 14.046

SECONDARY outcome

Timeframe: Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12)

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.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point Week 4	3.1 Units on a Scale Standard Deviation 6.35	1.7 Units on a Scale Standard Deviation 6.15
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point Week 12	3.1 Units on a Scale Standard Deviation 7.59	2.9 Units on a Scale Standard Deviation 6.88
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point End of Study	3.1 Units on a Scale Standard Deviation 7.59	2.5 Units on a Scale Standard Deviation 7.20

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline Used	6.46 Units on a Scale Standard Deviation 15.728	5.80 Units on a Scale Standard Deviation 11.364
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline Not used	10.60 Units on a Scale Standard Deviation 16.408	6.68 Units on a Scale Standard Deviation 15.603

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=108 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline Used	1.7 Units on a Scale Standard Deviation 8.44	1.2 Units on a Scale Standard Deviation 4.52
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline Not used	4.3 Units on a Scale Standard Deviation 6.61	3.3 Units on a Scale Standard Deviation 8.37

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.

Outcome measures

Outcome measures
Measure	Trelagliptin n=50 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=41 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline <2 times	6.26 Units on a Scale Standard Deviation 16.035	5.57 Units on a Scale Standard Deviation 11.519
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline ≥2 times	8.76 Units on a Scale Standard Deviation 13.259	10.34 Units on a Scale Standard Deviation 8.940

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=50 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=41 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline <2 times	1.3 Units on a Scale Standard Deviation 8.29	1.2 Units on a Scale Standard Deviation 4.58
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline ≥2 times	6.8 Units on a Scale Standard Deviation 9.71	2.0 Units on a Scale Standard Deviation 4.24

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=50 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=41 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline <2 tablets	5.72 Units on a Scale Standard Deviation 16.048	6.00 Units on a Scale Standard Deviation 11.346
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline ≥2 tablets	11.88 Units on a Scale Standard Deviation 13.008	3.26 Units on a Scale Standard Deviation 13.809

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=50 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=41 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline <2 tablets	1.1 Units on a Scale Standard Deviation 8.42	1.2 Units on a Scale Standard Deviation 4.64
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline ≥2 tablets	6.3 Units on a Scale Standard Deviation 7.71	1.7 Units on a Scale Standard Deviation 3.06

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline Once Weekly	8.72 Units on a Scale Standard Deviation 16.162	—
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline Twice Daily	—	-0.50 Units on a Scale Standard Deviation 11.176
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline Once Daily	—	6.90 Units on a Scale Standard Deviation 14.204

SECONDARY outcome

Timeframe: Baseline (Week 0), up to the end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=108 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline Once Weekly	3.1 Units on a Scale Standard Deviation 7.59	—
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline Once Daily	—	2.8 Units on a Scale Standard Deviation 6.73
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline Twice Daily	—	-0.5 Units on a Scale Standard Deviation 11.89

SECONDARY outcome

Timeframe: Baseline (Week 0), up to end of study (Week 12)

Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 2	1.0 Units on a Scale Standard Deviation 2.25	0.7 Units on a Scale Standard Deviation 1.73
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 1	0.9 Units on a Scale Standard Deviation 2.39	0.5 Units on a Scale Standard Deviation 1.89
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 3	0.5 Units on a Scale Standard Deviation 1.89	0.2 Units on a Scale Standard Deviation 1.76
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 4	0.7 Units on a Scale Standard Deviation 2.27	0.5 Units on a Scale Standard Deviation 1.72
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 5	0.3 Units on a Scale Standard Deviation 1.73	0.4 Units on a Scale Standard Deviation 1.42
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 6	0.6 Units on a Scale Standard Deviation 1.90	0.5 Units on a Scale Standard Deviation 1.80
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 7	0.9 Units on a Scale Standard Deviation 1.83	0.7 Units on a Scale Standard Deviation 1.88
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 8	0.8 Units on a Scale Standard Deviation 1.80	1.0 Units on a Scale Standard Deviation 1.75
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 9	0.8 Units on a Scale Standard Deviation 1.85	0.5 Units on a Scale Standard Deviation 1.97
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 10	0.7 Units on a Scale Standard Deviation 1.64	0.5 Units on a Scale Standard Deviation 1.52
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 11	0.3 Units on a Scale Standard Deviation 1.71	0.3 Units on a Scale Standard Deviation 1.59
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 12	0.6 Units on a Scale Standard Deviation 1.54	0.5 Units on a Scale Standard Deviation 1.29
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 13	0.5 Units on a Scale Standard Deviation 1.59	0.6 Units on a Scale Standard Deviation 1.42
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 14	0.5 Units on a Scale Standard Deviation 1.62	0.4 Units on a Scale Standard Deviation 1.75
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 15	0.3 Units on a Scale Standard Deviation 1.75	0.3 Units on a Scale Standard Deviation 1.69
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 16	0.4 Units on a Scale Standard Deviation 1.54	0.5 Units on a Scale Standard Deviation 1.31
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 17	0.3 Units on a Scale Standard Deviation 1.44	0.4 Units on a Scale Standard Deviation 1.42
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 18	0.5 Units on a Scale Standard Deviation 1.65	0.4 Units on a Scale Standard Deviation 1.47
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 19	0.2 Units on a Scale Standard Deviation 1.72	0.2 Units on a Scale Standard Deviation 1.35
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 20	0.5 Units on a Scale Standard Deviation 1.95	0.1 Units on a Scale Standard Deviation 1.93
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 21	0.4 Units on a Scale Standard Deviation 1.72	0.0 Units on a Scale Standard Deviation 1.62
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 22	0.6 Units on a Scale Standard Deviation 1.71	0.1 Units on a Scale Standard Deviation 1.92
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 23	0.4 Units on a Scale Standard Deviation 1.81	0.1 Units on a Scale Standard Deviation 1.60
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 24	0.2 Units on a Scale Standard Deviation 1.91	0.1 Units on a Scale Standard Deviation 1.65
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 25	0.2 Units on a Scale Standard Deviation 1.68	0.0 Units on a Scale Standard Deviation 1.43
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 26	0.7 Units on a Scale Standard Deviation 1.89	0.4 Units on a Scale Standard Deviation 1.49
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 27	0.4 Units on a Scale Standard Deviation 1.77	0.3 Units on a Scale Standard Deviation 1.48
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 28	0.3 Units on a Scale Standard Deviation 1.69	0.3 Units on a Scale Standard Deviation 1.33
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study Question Number 29	0.8 Units on a Scale Standard Deviation 1.59	0.4 Units on a Scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline (Week 0), up to end of study (Week 12)

Outcome measures

Outcome measures
Measure	Trelagliptin n=108 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 1	0.7 Units on a Scale Standard Deviation 1.50	0.6 Units on a Scale Standard Deviation 1.47
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 2	-0.4 Units on a Scale Standard Deviation 1.77	-0.5 Units on a Scale Standard Deviation 2.08
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 3	0.0 Units on a Scale Standard Deviation 1.54	-0.2 Units on a Scale Standard Deviation 1.76
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 4	0.8 Units on a Scale Standard Deviation 1.57	0.5 Units on a Scale Standard Deviation 1.60
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 5	0.6 Units on a Scale Standard Deviation 1.61	0.5 Units on a Scale Standard Deviation 1.47
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 6	0.1 Units on a Scale Standard Deviation 1.47	0.2 Units on a Scale Standard Deviation 1.39
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 7	0.5 Units on a Scale Standard Deviation 1.51	0.3 Units on a Scale Standard Deviation 1.25
Change From Baseline in Score Per Question in the the DTSQ at the End of Study Question Number 8	0.5 Units on a Scale Standard Deviation 1.44	0.4 Units on a Scale Standard Deviation 1.56

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Number of Participants Reporting One or More Treatment-emergent Adverse Events	19 Participants	20 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Number of Participants Reporting One or More Hypoglycemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: There were no participants with hospitalization related to type 2 diabetes mellitus during this study.

The investigators checked any hospitalization of study participants for type 2 diabetes after the first administration of the study drug or comparative drug (excluding educational hospitalization without worsening of diabetes).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.

Outcome measures

Outcome measures
Measure	Trelagliptin n=110 Participants Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 Participants An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)	0 Participants	0 Participants

Adverse Events

Trelagliptin

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Daily DPP-4 Inhibitors

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trelagliptin n=110 participants at risk Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 participants at risk An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Ear and labyrinth disorders Vertigo	0.91% 1/110 • Up to Week 12 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/108 • Up to Week 12 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Diverticulitis	0.91% 1/110 • Up to Week 12 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/108 • Up to Week 12 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Trelagliptin n=110 participants at risk Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.	Daily DPP-4 Inhibitors n=108 participants at risk An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Infections and infestations Viral upper respiratory tract infection	3.6% 4/110 • Up to Week 12 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 2/108 • Up to Week 12 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER