| 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0008.72± 16.162
- OG0016.35± 14.093
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.2305 | | Differences of Least Square Means | 2.418 | | | 2-Sided | 95 | -1.546 | 6.382 | | | Trelagliptin - Daily DPP-4 inhibitors | | Superiority | | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Daily DPP-4 Inhibitors |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to Week 4, 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Daily DPP-4 Inhibitors | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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). | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to the end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Week 0), up to end of study (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period. | Posted | | Count of Participants | | Participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Number of Participants Reporting One or More Hypoglycemia | | Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period. | Posted | | Count of Participants | | Participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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). | There were no participants with hospitalization related to type 2 diabetes mellitus during this study. | Posted | | | | | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) | | Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period. | Posted | | Count of Participants | | Participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |