TRENDS: Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03014479
• Collaborator: (none)
• Enrollment: 219
• Locations: 27
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site: 8.1
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Trelagliptin; Drug: Daily DPP-4 inhibitor	Phase 4

Detailed Description

The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only. Eligible participants will be randomized to either the study drug (trelagliptin) group or the comparative drug (daily DPP-4 inhibitor) group. Treatment burden will be assessed using Diabetes Therapy Related -QOL (DTR-QOL) questionnaire and Diabetes Treatment Satisfaction Questionnaire (DTSQ).

Study Design

• Study Type: Interventional
• Actual Enrollment: 219 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Feb 18, 2017
• Actual Primary Completion Date: Oct 21, 2017
• Actual Study Completion Date: Oct 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Trelagliptin; Trelagliptin 100 mg or 50 mg
Active Comparator: 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.	Drug: Daily DPP-4 inhibitor; Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study [Baseline (Week 0), up to the end of study (Week 12)]

   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.

Secondary Outcome Measures

1. 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 [Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)]

   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.

2. 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 [Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)]

   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.

3. Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point [Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)]

   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.

4. 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 [Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)]

   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.

5. Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point [Baseline (Week 0), up to Week 4, 12]

   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.

6. Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point [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.

7. 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 [Baseline (Week 0), up to the end of study (Week 12)]

   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. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).

8. 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 [Baseline (Week 0), up to 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. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).

9. 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 [Baseline (Week 0), up to the end of study (Week 12)]

   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.

10. 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 [Baseline (Week 0), up to 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.

11. 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 [Baseline (Week 0), up to the end of study (Week 12)]

    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.

12. 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 [Baseline (Week 0), up to 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.

13. 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 [Baseline (Week 0), up to the end of study (Week 12)]

    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.

14. 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 [Baseline (Week 0), up to 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.

15. Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study [Baseline (Week 0), up to end of study (Week 12)]

    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.

16. Change From Baseline in Score Per Question in the the DTSQ at the End of Study [Baseline (Week 0), up to 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.

17. Number of Participants Reporting One or More Treatment-emergent Adverse Events [Up to 12 weeks]

    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.

18. Number of Participants Reporting One or More Hypoglycemia [Up to 12 weeks]

19. Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) [Up to 12 weeks]

    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).

20. Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) [Up to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 Hemoglobin A1c (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 received 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 with type 1 diabetes.

3. Participants with severe renal impairment or renal failure (e.g., estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 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 planning pregnancy during the study period.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Takeda Selected Site 17	Nagoya	Aichi	Japan
2	Takeda Selected Site 18	Nagoya	Aichi	Japan
3	Takeda Selected Site 25	Kanra	Gunma	Japan
4	Takeda Selected Site 9	Kobe	Hyogo	Japan
5	Takeda Selected Site 27	Koga	Ibaraki	Japan
6	Takeda Selected Site 14	Kawasaki	Kanagawa	Japan
7	Takeda Selected Site 11	Sagamihara	Kanagawa	Japan
8	Takeda Selected Site 10	Yamato	Kanagawa	Japan
9	Takeda Selected Site 4	Sendai	Miyagi	Japan
10	Takeda Selected Site 5	Sendai	Miyagi	Japan
11	Takeda Selected Site 3	Kashihara	Nara	Japan
12	Takeda Selected Site 15	Kashiwara	Osaka	Japan
13	Takeda Selected Site 1	Suita	Osaka	Japan
14	Takeda Selected Site 24	Okegawa	Saitama	Japan
15	Takeda Selected Site 26	Oyama	Tochigi	Japan
16	Takeda Selected Site 23	Adachi-ku	Tokyo	Japan
17	Takeda Selected Site 6	Chuo-ku	Tokyo	Japan
18	Takeda Selected Site 7	Chuo-ku	Tokyo	Japan
19	Takeda Selected Site 22	Edogawa-ku	Tokyo	Japan
20	Takeda Selected Site 19	Musashino	Tokyo	Japan
21	Takeda Selected Site 21	Ota-ku	Tokyo	Japan
22	Takeda Selected Site 12	Shibuya-ku	Tokyo	Japan
23	Takeda Selected Site 13	Shinagawa-ku	Tokyo	Japan
24	Takeda Selected Site 20	Shinagawa-ku	Tokyo	Japan
25	Takeda Selected Site 2	Shinjuku-ku	Tokyo	Japan
26	Takeda Selected Site 8	Shinjuku-ku	Tokyo	Japan
27	Takeda Selected Site 16	Osaka		Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

• Study Protocol - Jul 5, 2017
• Statistical Analysis Plan - Dec 28, 2017

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT03014479
• Other Study ID Numbers: Trelagliptin-4002; JapicCTI-173482; U1111-1189-9256
• First Posted: Jan 9, 2017
• Last Update Posted: Mar 6, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 25 investigative sites in Japan, from 18 February 2017 to 21 October 2017.
Pre-assignment Detail	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).

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Period Title: Overall Study
STARTED	110	109
COMPLETED	110	105
NOT COMPLETED	0	4

Baseline Characteristics

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors	Total
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.	Total of all reporting groups
Overall Participants	110	108	218
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.5 (8.96)	58.4 (10.01)	59.9 (9.60)
Sex: Female, Male (Count of Participants)
Female	24 21.8%	26 24.1%	50 22.9%
Male	86 78.2%	82 75.9%	168 77.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Number) [Number]
Japan	110 100%	108 100%	218 100%
Height (Centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeter (cm)]	165.0 (9.56)	165.6 (9.29)	165.3 (9.41)
Weight (Kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram (kg)]	67.57 (11.917)	70.51 (15.707)	69.03 (13.969)
Body Mass Index (BMI) (Kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram per square meter (kg/m^2)]	24.72 (3.224)	25.53 (4.349)	25.12 (3.836)
Smoking Classification (Count of Participants)
Never smoked	48 43.6%	40 37%	88 40.4%
Current smoker	24 21.8%	28 25.9%	52 23.9%
Ex-smoker	38 34.5%	40 37%	78 35.8%
Alcohol Classification (Count of Participants)
Yes	38 34.5%	36 33.3%	74 33.9%
No	72 65.5%	72 66.7%	144 66.1%
Duration of type 2 diabetes mellitus (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	6.45 (4.972)	6.39 (5.286)	6.42 (5.118)
Any Medication for Concurrent Condition (Count of Participants)
Had Any Medication	50 45.5%	41 38%	91 41.7%
Had No Any Medication	60 54.5%	67 62%	127 58.3%
Number of Daily Doses of Medication (Concurrent Condition Medicine.) (Count of Participants)
Less than (<) 2 Times	46 41.8%	39 36.1%	85 39%
Greater than or Equal to (≥) 2 Times	4 3.6%	2 1.9%	6 2.8%
Total Number of Daily Tablets (Concurrent Condition Medicine.) (Count of Participants)
<2 Tablets	44 40%	38 35.2%	82 37.6%
≥2 Tablets	6 5.5%	3 2.8%	9 4.1%
Number of Doses of Drugs (Study drug.) (Count of Participants)
Once a Week	110 100%	0 0%	110 50.5%
Once daily	0 0%	100 92.6%	100 45.9%
Twice daily	0 0%	8 7.4%	8 3.7%
Glycated hemoglobin A1c (HbA1c) (Percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent]	7.37 (0.730)	7.37 (0.624)	7.37 (0.678)
DTR-QOL Total Score at Week-4 (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	66.41 (15.934)	66.37 (14.725)	66.39 (15.311)
DTR-QOL Total Score at Week 0 (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	68.48 (17.158)	68.86 (16.240)	68.67 (16.673)
DTR-QOL Total Score; Factor 1 at Week 0 (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	73.31 (20.934)	73.48 (20.060)	73.39 (20.459)
DTR-QOL Total Score; Factor 2 at Week 0 (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	62.94 (20.334)	65.10 (19.725)	64.01 (20.018)
DTR-QOL Total Score; Factor 3 at Week 0 (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	79.13 (24.721)	78.97 (23.254)	79.05 (23.950)
DTR-QOL Total Score; Factor 4 at Week 0 (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	53.22 (16.539)	51.27 (16.347)	52.26 (16.435)
DTSQ Total score (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	22.31 (5.444)	21.56 (5.679)	21.94 (5.562)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study
Description	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.
Time Frame	Baseline (Week 0), up to the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Mean (Standard Deviation) [Units on a Scale]	8.72 (16.162)	6.35 (14.093)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trelagliptin, Daily DPP-4 Inhibitors
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2305
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Differences of Least Square Means
	Estimated Value	2.418
	Confidence Interval	(2-Sided) 95%; -1.546 to 6.382
	Parameter Dispersion	Type: Value:
	Estimation Comments	Trelagliptin - Daily DPP-4 inhibitors

2. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Week 4	11.24 (18.200)	7.83 (19.426)
Week 12	10.98 (20.116)	9.12 (18.560)
End of Study	10.79 (20.126)	8.92 (19.048)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trelagliptin, Daily DPP-4 Inhibitors
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4536
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Differences of Least Square Means
	Estimated Value	1.938
	Confidence Interval	(2-Sided) 95%; -3.150 to 7.027
	Parameter Dispersion	Type: Value:
	Estimation Comments	Trelagliptin - Daily DPP-4 inhibitors

3. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Week 4	5.18 (14.925)	0.39 (13.769)
Week 12	5.94 (18.577)	2.18 (17.498)
End of Study	6.23 (18.735)	2.10 (17.315)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trelagliptin, Daily DPP-4 Inhibitors
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0896
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Differences of Least Square Means
	Estimated Value	4.160
	Confidence Interval	(2-Sided) 95%; -0.649 to 8.968
	Parameter Dispersion	Type: Value:
	Estimation Comments	Trelagliptin - Daily DPP-4 inhibitors

4. Secondary Outcome

Title	Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point
Description	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.
Time Frame	Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Week 4	6.15 (23.155)	4.87 (22.298)
Week 12	5.85 (22.837)	7.38 (21.224)
End of Study	6.06 (22.840)	6.67 (21.586)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trelagliptin, Daily DPP-4 Inhibitors
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8506
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Differences of Least Square Means
	Estimated Value	-0.563
	Confidence Interval	(2-Sided) 95%; -6.448 to 5.323
	Parameter Dispersion	Type: Value:
	Estimation Comments	Trelagliptin - Daily DPP-4 inhibitors

5. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Week 4	5.24 (22.254)	3.85 (17.143)
Week 12	8.53 (23.607)	6.71 (18.431)
End of Study	8.86 (23.806)	6.17 (18.507)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trelagliptin, Daily DPP-4 Inhibitors
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3533
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Differences of Least Square Means
	Estimated Value	2.696
	Confidence Interval	(2-Sided) 95%; -3.018 to 8.410
	Parameter Dispersion	Type: Value:
	Estimation Comments	Trelagliptin - Daily DPP-4 inhibitors

6. Secondary Outcome

Title	Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point
Description	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.
Time Frame	Baseline (Week 0), up to Week 4, 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Week 4	8.04 (13.111)	4.82 (12.776)
Week 12	8.58 (16.280)	6.63 (14.046)

7. Secondary Outcome

Title	Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point
Description	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	Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Week 4	3.1 (6.35)	1.7 (6.15)
Week 12	3.1 (7.59)	2.9 (6.88)
End of Study	3.1 (7.59)	2.5 (7.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trelagliptin, Daily DPP-4 Inhibitors
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5451
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Differences of Least Square Means
	Estimated Value	0.613
	Confidence Interval	(2-Sided) 95%; -1.380 to 2.605
	Parameter Dispersion	Type: Value:
	Estimation Comments	Trelagliptin - Daily DPP-4 inhibitors

8. Secondary Outcome

Title	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
Description	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. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).
Time Frame	Baseline (Week 0), up to the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Used	6.46 (15.728)	5.80 (11.364)
Not used	10.60 (16.408)	6.68 (15.603)

9. Secondary Outcome

Title	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
Description	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. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).
Time Frame	Baseline (Week 0), up to the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	108	108
Used	1.7 (8.44)	1.2 (4.52)
Not used	4.3 (6.61)	3.3 (8.37)

10. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline (Week 0), up to the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	50	41
<2 times	6.26 (16.035)	5.57 (11.519)
≥2 times	8.76 (13.259)	10.34 (8.940)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	50	41
<2 times	1.3 (8.29)	1.2 (4.58)
≥2 times	6.8 (9.71)	2.0 (4.24)

12. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline (Week 0), up to the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	50	41
<2 tablets	5.72 (16.048)	6.00 (11.346)
≥2 tablets	11.88 (13.008)	3.26 (13.809)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	50	41
<2 tablets	1.1 (8.42)	1.2 (4.64)
≥2 tablets	6.3 (7.71)	1.7 (3.06)

14. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline (Week 0), up to the end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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 population.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Once Weekly	8.72 (16.162)
Once Daily	6.90 (14.204)
Twice Daily	-0.50 (11.176)

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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 population.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	108	108
Once Weekly	3.1 (7.59)
Once Daily	2.8 (6.73)
Twice Daily	-0.5 (11.89)

16. Secondary Outcome

Title	Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study
Description	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.
Time Frame	Baseline (Week 0), up to end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Question Number 1	0.9 (2.39)	0.5 (1.89)
Question Number 2	1.0 (2.25)	0.7 (1.73)
Question Number 3	0.5 (1.89)	0.2 (1.76)
Question Number 4	0.7 (2.27)	0.5 (1.72)
Question Number 5	0.3 (1.73)	0.4 (1.42)
Question Number 6	0.6 (1.90)	0.5 (1.80)
Question Number 7	0.9 (1.83)	0.7 (1.88)
Question Number 8	0.8 (1.80)	1.0 (1.75)
Question Number 9	0.8 (1.85)	0.5 (1.97)
Question Number 10	0.7 (1.64)	0.5 (1.52)
Question Number 11	0.3 (1.71)	0.3 (1.59)
Question Number 12	0.6 (1.54)	0.5 (1.29)
Question Number 13	0.5 (1.59)	0.6 (1.42)
Question Number 14	0.5 (1.62)	0.4 (1.75)
Question Number 15	0.3 (1.75)	0.3 (1.69)
Question Number 16	0.4 (1.54)	0.5 (1.31)
Question Number 17	0.3 (1.44)	0.4 (1.42)
Question Number 18	0.5 (1.65)	0.4 (1.47)
Question Number 19	0.2 (1.72)	0.2 (1.35)
Question Number 20	0.5 (1.95)	0.1 (1.93)
Question Number 21	0.4 (1.72)	0.0 (1.62)
Question Number 22	0.6 (1.71)	0.1 (1.92)
Question Number 23	0.4 (1.81)	0.1 (1.60)
Question Number 24	0.2 (1.91)	0.1 (1.65)
Question Number 25	0.2 (1.68)	0.0 (1.43)
Question Number 26	0.7 (1.89)	0.4 (1.49)
Question Number 27	0.4 (1.77)	0.3 (1.48)
Question Number 28	0.3 (1.69)	0.3 (1.33)
Question Number 29	0.8 (1.59)	0.4 (1.40)

17. Secondary Outcome

Title	Change From Baseline in Score Per Question in the the DTSQ at the End of Study
Description	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	Baseline (Week 0), up to end of study (Week 12)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	108	108
Question Number 1	0.7 (1.50)	0.6 (1.47)
Question Number 2	-0.4 (1.77)	-0.5 (2.08)
Question Number 3	0.0 (1.54)	-0.2 (1.76)
Question Number 4	0.8 (1.57)	0.5 (1.60)
Question Number 5	0.6 (1.61)	0.5 (1.47)
Question Number 6	0.1 (1.47)	0.2 (1.39)
Question Number 7	0.5 (1.51)	0.3 (1.25)
Question Number 8	0.5 (1.44)	0.4 (1.56)

18. Secondary Outcome

Title	Number of Participants Reporting One or More Treatment-emergent Adverse Events
Description	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.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Count of Participants [Participants]	19 17.3%	20 18.5%

19. Secondary Outcome

Title	Number of Participants Reporting One or More Hypoglycemia
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Count of Participants [Participants]	0 0%	0 0%

20. Secondary Outcome

Title	Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
Description	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).
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	0	0

21. Secondary Outcome

Title	Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Trelagliptin	Daily DPP-4 Inhibitors
Arm/Group Description	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.	An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
Measure Participants	110	108
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Up to Week 12
Adverse Event Reporting Description	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.
Arm/Group Title	Trelagliptin		Daily DPP-4 Inhibitors
Arm/Group Description	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.		An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
All Cause Mortality
	Trelagliptin		Daily DPP-4 Inhibitors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/108 (0%)
Serious Adverse Events
	Trelagliptin		Daily DPP-4 Inhibitors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/110 (1.8%)		0/108 (0%)
Ear and labyrinth disorders
Vertigo	1/110 (0.9%)		0/108 (0%)
Infections and infestations
Diverticulitis	1/110 (0.9%)		0/108 (0%)
Other (Not Including Serious) Adverse Events
	Trelagliptin		Daily DPP-4 Inhibitors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/110 (3.6%)		2/108 (1.9%)
Infections and infestations
Viral upper respiratory tract infection	4/110 (3.6%)		2/108 (1.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.