Type 2 Diabetes
Conditions
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.
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).
Interventions
DRUGTrelagliptin
Trelagliptin 100 mg or 50 mg
Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Number of Participants Reporting One or More Hypoglycemia | Up to 12 weeks | — |
| 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). |
| Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) | 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 | 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. |
Countries
Japan
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 details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 110 |
| 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. | 108 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Unacceptable Inability of Site Visit | 0 | 1 |
| Overall Study | Voluntary Withdrawal | 0 | 2 |
Baseline characteristics
| Characteristic | Trelagliptin | Daily DPP-4 Inhibitors | Total |
|---|---|---|---|
| Age, Continuous | 61.5 Years STANDARD_DEVIATION 8.96 | 58.4 Years STANDARD_DEVIATION 10.01 | 59.9 Years STANDARD_DEVIATION 9.6 |
| Alcohol Classification No | 72 Participants | 72 Participants | 144 Participants |
| Alcohol Classification Yes | 38 Participants | 36 Participants | 74 Participants |
| Any Medication for Concurrent Condition Had Any Medication | 50 Participants | 41 Participants | 91 Participants |
| Any Medication for Concurrent Condition Had No Any Medication | 60 Participants | 67 Participants | 127 Participants |
| Body Mass Index (BMI) | 24.72 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.224 | 25.53 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.349 | 25.12 Kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.836 |
| DTR-QOL Total Score at Week 0 | 68.48 Units on a Scale STANDARD_DEVIATION 17.158 | 68.86 Units on a Scale STANDARD_DEVIATION 16.24 | 68.67 Units on a Scale STANDARD_DEVIATION 16.673 |
| DTR-QOL Total Score at Week-4 | 66.41 Units on a Scale STANDARD_DEVIATION 15.934 | 66.37 Units on a Scale STANDARD_DEVIATION 14.725 | 66.39 Units on a Scale STANDARD_DEVIATION 15.311 |
| DTR-QOL Total Score; Factor 1 at Week 0 | 73.31 Units on a Scale STANDARD_DEVIATION 20.934 | 73.48 Units on a Scale STANDARD_DEVIATION 20.06 | 73.39 Units on a Scale STANDARD_DEVIATION 20.459 |
| DTR-QOL Total Score; Factor 2 at Week 0 | 62.94 Units on a Scale STANDARD_DEVIATION 20.334 | 65.10 Units on a Scale STANDARD_DEVIATION 19.725 | 64.01 Units on a Scale STANDARD_DEVIATION 20.018 |
| DTR-QOL Total Score; Factor 3 at Week 0 | 79.13 Units on a Scale STANDARD_DEVIATION 24.721 | 78.97 Units on a Scale STANDARD_DEVIATION 23.254 | 79.05 Units on a Scale STANDARD_DEVIATION 23.95 |
| DTR-QOL Total Score; Factor 4 at Week 0 | 53.22 Units on a Scale STANDARD_DEVIATION 16.539 | 51.27 Units on a Scale STANDARD_DEVIATION 16.347 | 52.26 Units on a Scale STANDARD_DEVIATION 16.435 |
| DTSQ Total score | 22.31 Units on a Scale STANDARD_DEVIATION 5.444 | 21.56 Units on a Scale STANDARD_DEVIATION 5.679 | 21.94 Units on a Scale STANDARD_DEVIATION 5.562 |
| Duration of type 2 diabetes mellitus | 6.45 Years STANDARD_DEVIATION 4.972 | 6.39 Years STANDARD_DEVIATION 5.286 | 6.42 Years STANDARD_DEVIATION 5.118 |
| Glycated hemoglobin A1c (HbA1c) | 7.37 Percent STANDARD_DEVIATION 0.73 | 7.37 Percent STANDARD_DEVIATION 0.624 | 7.37 Percent STANDARD_DEVIATION 0.678 |
| Height | 165.0 Centimeter (cm) STANDARD_DEVIATION 9.56 | 165.6 Centimeter (cm) STANDARD_DEVIATION 9.29 | 165.3 Centimeter (cm) STANDARD_DEVIATION 9.41 |
| Number of Daily Doses of Medication (Concurrent Condition Medicine.) Greater than or Equal to (≥) 2 Times | 4 Participants | 2 Participants | 6 Participants |
| Number of Daily Doses of Medication (Concurrent Condition Medicine.) Less than (<) 2 Times | 46 Participants | 39 Participants | 85 Participants |
| Number of Doses of Drugs (Study drug.) Once a Week | 110 Participants | 0 Participants | 110 Participants |
| Number of Doses of Drugs (Study drug.) Once daily | 0 Participants | 100 Participants | 100 Participants |
| Number of Doses of Drugs (Study drug.) Twice daily | 0 Participants | 8 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Japan | 110 Participants | 108 Participants | 218 Participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 86 Participants | 82 Participants | 168 Participants |
| Smoking Classification Current smoker | 24 Participants | 28 Participants | 52 Participants |
| Smoking Classification Ex-smoker | 38 Participants | 40 Participants | 78 Participants |
| Smoking Classification Never smoked | 48 Participants | 40 Participants | 88 Participants |
| Total Number of Daily Tablets (Concurrent Condition Medicine.) <2 Tablets | 44 Participants | 38 Participants | 82 Participants |
| Total Number of Daily Tablets (Concurrent Condition Medicine.) ≥2 Tablets | 6 Participants | 3 Participants | 9 Participants |
| Weight | 67.57 Kilogram (kg) STANDARD_DEVIATION 11.917 | 70.51 Kilogram (kg) STANDARD_DEVIATION 15.707 | 69.03 Kilogram (kg) STANDARD_DEVIATION 13.969 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 108 |
| other Total, other adverse events | 4 / 110 | 2 / 108 |
| serious Total, serious adverse events | 2 / 110 | 0 / 108 |
Outcome results
Primary
Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study
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)
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study | 6.35 Units on a Scale | Standard Deviation 14.093 |
p-value: 0.230595% CI: [-1.546, 6.382]ANCOVA
Secondary
Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study
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)
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 1.9 |
| Trelagliptin | 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 |
| Trelagliptin | 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 1.8 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 1.69 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 1 | 0.5 Units on a Scale | Standard Deviation 1.89 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 26 | 0.4 Units on a Scale | Standard Deviation 1.49 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 2 | 0.7 Units on a Scale | Standard Deviation 1.73 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 16 | 0.5 Units on a Scale | Standard Deviation 1.31 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 3 | 0.2 Units on a Scale | Standard Deviation 1.76 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 23 | 0.1 Units on a Scale | Standard Deviation 1.6 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 4 | 0.5 Units on a Scale | Standard Deviation 1.72 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 17 | 0.4 Units on a Scale | Standard Deviation 1.42 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 5 | 0.4 Units on a Scale | Standard Deviation 1.42 |
| Daily DPP-4 Inhibitors | 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 1.33 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 6 | 0.5 Units on a Scale | Standard Deviation 1.8 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 18 | 0.4 Units on a Scale | Standard Deviation 1.47 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 7 | 0.7 Units on a Scale | Standard Deviation 1.88 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 24 | 0.1 Units on a Scale | Standard Deviation 1.65 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 8 | 1.0 Units on a Scale | Standard Deviation 1.75 |
| Daily DPP-4 Inhibitors | 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 1.35 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 9 | 0.5 Units on a Scale | Standard Deviation 1.97 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 27 | 0.3 Units on a Scale | Standard Deviation 1.48 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 10 | 0.5 Units on a Scale | Standard Deviation 1.52 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 20 | 0.1 Units on a Scale | Standard Deviation 1.93 |
| Daily DPP-4 Inhibitors | 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 1.59 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 25 | 0.0 Units on a Scale | Standard Deviation 1.43 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 12 | 0.5 Units on a Scale | Standard Deviation 1.29 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 21 | 0.0 Units on a Scale | Standard Deviation 1.62 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 13 | 0.6 Units on a Scale | Standard Deviation 1.42 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 29 | 0.4 Units on a Scale | Standard Deviation 1.4 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 14 | 0.4 Units on a Scale | Standard Deviation 1.75 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study | Question Number 22 | 0.1 Units on a Scale | Standard Deviation 1.92 |
Secondary
Change From Baseline in Score Per Question in the the DTSQ at the End of Study
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 1.5 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 8 | 0.4 Units on a Scale | Standard Deviation 1.56 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 1 | 0.6 Units on a Scale | Standard Deviation 1.47 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 5 | 0.5 Units on a Scale | Standard Deviation 1.47 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 2 | -0.5 Units on a Scale | Standard Deviation 2.08 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 7 | 0.3 Units on a Scale | Standard Deviation 1.25 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 3 | -0.2 Units on a Scale | Standard Deviation 1.76 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 6 | 0.2 Units on a Scale | Standard Deviation 1.39 |
| Daily DPP-4 Inhibitors | Change From Baseline in Score Per Question in the the DTSQ at the End of Study | Question Number 4 | 0.5 Units on a Scale | Standard Deviation 1.6 |
Secondary
Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 16.28 |
| Daily DPP-4 Inhibitors | Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point | Week 4 | 4.82 Units on a Scale | Standard Deviation 12.776 |
| Daily DPP-4 Inhibitors | Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point | Week 12 | 6.63 Units on a Scale | Standard Deviation 14.046 |
Secondary
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 5.57 Units on a Scale | Standard Deviation 11.519 |
| Daily DPP-4 Inhibitors | 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 | 10.34 Units on a Scale | Standard Deviation 8.94 |
Secondary
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
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)
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 population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 |
| Daily DPP-4 Inhibitors | 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 |
Secondary
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 6.00 Units on a Scale | Standard Deviation 11.346 |
| Daily DPP-4 Inhibitors | 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 | 3.26 Units on a Scale | Standard Deviation 13.809 |
Secondary
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
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)
Population: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 5.80 Units on a Scale | Standard Deviation 11.364 |
| Daily DPP-4 Inhibitors | 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 | 6.68 Units on a Scale | Standard Deviation 15.603 |
Secondary
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 18.2 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 7.83 Units on a Scale | Standard Deviation 19.426 |
| Daily DPP-4 Inhibitors | 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 | 9.12 Units on a Scale | Standard Deviation 18.56 |
| Daily DPP-4 Inhibitors | 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 | 8.92 Units on a Scale | Standard Deviation 19.048 |
p-value: 0.453695% CI: [-3.15, 7.027]ANCOVA
Secondary
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 0.39 Units on a Scale | Standard Deviation 13.769 |
| Daily DPP-4 Inhibitors | 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 | 2.18 Units on a Scale | Standard Deviation 17.498 |
| Daily DPP-4 Inhibitors | 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 | 2.10 Units on a Scale | Standard Deviation 17.315 |
p-value: 0.089695% CI: [-0.649, 8.968]ANCOVA
Secondary
Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 22.84 |
| Daily DPP-4 Inhibitors | 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 | 4.87 Units on a Scale | Standard Deviation 22.298 |
| Daily DPP-4 Inhibitors | 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 | 7.38 Units on a Scale | Standard Deviation 21.224 |
| Daily DPP-4 Inhibitors | 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 | 6.67 Units on a Scale | Standard Deviation 21.586 |
p-value: 0.850695% CI: [-6.448, 5.323]ANCOVA
Secondary
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 3.85 Units on a Scale | Standard Deviation 17.143 |
| Daily DPP-4 Inhibitors | 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 | 6.71 Units on a Scale | Standard Deviation 18.431 |
| Daily DPP-4 Inhibitors | 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 | 6.17 Units on a Scale | Standard Deviation 18.507 |
p-value: 0.353395% CI: [-3.018, 8.41]ANCOVA
Secondary
Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point
The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 1.7 Units on a Scale | Standard Deviation 6.15 |
| Daily DPP-4 Inhibitors | 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 | 2.9 Units on a Scale | Standard Deviation 6.88 |
| Daily DPP-4 Inhibitors | 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 | 2.5 Units on a Scale | Standard Deviation 7.2 |
p-value: 0.545195% CI: [-1.38, 2.605]ANCOVA
Secondary
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 1.2 Units on a Scale | Standard Deviation 4.58 |
| Daily DPP-4 Inhibitors | 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 | 2.0 Units on a Scale | Standard Deviation 4.24 |
Secondary
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
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)
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 population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 |
| Daily DPP-4 Inhibitors | 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
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 1.2 Units on a Scale | Standard Deviation 4.64 |
| Daily DPP-4 Inhibitors | 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 | 1.7 Units on a Scale | Standard Deviation 3.06 |
Secondary
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
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin | 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 |
| Trelagliptin | 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 |
| Daily DPP-4 Inhibitors | 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 | 1.2 Units on a Scale | Standard Deviation 4.52 |
| Daily DPP-4 Inhibitors | 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 | 3.3 Units on a Scale | Standard Deviation 8.37 |
Secondary
Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
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
Population: There were no participants with hospitalization related to type 2 diabetes mellitus during this study.
Secondary
Number of Participants Reporting One or More Hypoglycemia
Time frame: Up to 12 weeks
Population: Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin | Number of Participants Reporting One or More Hypoglycemia | 0 Participants |
| Daily DPP-4 Inhibitors | Number of Participants Reporting One or More Hypoglycemia | 0 Participants |
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events
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
Population: Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin | Number of Participants Reporting One or More Treatment-emergent Adverse Events | 19 Participants |
| Daily DPP-4 Inhibitors | Number of Participants Reporting One or More Treatment-emergent Adverse Events | 20 Participants |
Secondary
Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
Time frame: Up to 12 weeks
Population: Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin | Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) | 0 Participants |
| Daily DPP-4 Inhibitors | Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) | 0 Participants |