Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2, Diabetes, Diabetes Mellitus
Brief summary
This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).
Detailed description
The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective.
Interventions
DRUGTrelagliptin
Trelagliptin 100 mg tablet
DRUGAlogliptin
Alogliptin 25 mg tablet
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 who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements. 2. Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures. 3. Participants diagnosed with type 2 diabetes mellitus. 4. Participants with a glycated hemoglobin (HbA1c) \[National Glycohemoglobin Standardization Program (NGSP value)\] value ≥ 6.5% and \< 8.5% at the start of the observation period (Day -2). 5. Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks. 6. Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period. 7. Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period. 8. Men or women aged 20 years or older at the time of informed consent.
Exclusion criteria
1. Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period. 2. Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period. 3. Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period \[Day -2\]). 4. Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance \< 50 mL/min or serum creatinine \> 1.4 mg/dL in men or \> 1.2 mg/dL in women \[equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg\] at the start of the observation period \[Day -2\]). 5. Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases. 6. Participants with a history of gastric or small intestinal resection. 7. Participants with proliferative diabetic retinopathy. 8. Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma). 9. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors. 10. Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2). 11. Participants with any malignant tumors. 12. Habitual drinkers whose average daily alcohol consumption is \> 100 mL. 13. Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert. 14. Participants anticipated to require any prohibited concomitant medications during the study period. 15. Participants who are day and night lifestyle reversal. 16. Participants participating in any other clinical studies at the time of informed consent for this study. 17. Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant. 18. Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | Baseline, up to 28 days | Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 \[Day 22\] and Day 8 on Week 3 \[Day 28\]) of the treatment period, calculated from the value at the start of the observation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | Baseline, up to 28 days | Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | Baseline, up to 28 days | Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | Baseline, up to 28 days | Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | Baseline, up to 28 days | Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | Baseline, up to 28 days | Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | Baseline, up to 28 days | Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated. |
| Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | Baseline, up to 28 days | Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated. |
| Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | Baseline, up to 28 days | Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated. |
| Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | Baseline, up to 28 days | Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | Baseline, up to 28 days | Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated. |
| Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | Baseline, up to 28 days | Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | Baseline, up to 28 days | Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. |
| Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | Baseline, up to 28 days | Change from baseline in MAGE at each time points was calculated. |
| Change From Baseline in Mean 24-hour Blood Glucose Levels | Baseline, up to 28 days | Change from baseline in mean 24-hour blood glucose levels at each time points was calculated. |
| Change From Baseline in Mean Daytime Blood Glucose Levels | Baseline, up to 28 days | Change from baseline in mean daytime blood glucose levels at each time points was calculated. |
| Change From Baseline in Mean Nocturnal Blood Glucose Levels | Baseline, up to 28 days | Change from baseline in mean nocturnal blood glucose levels at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose | Baseline, up to 28 days | Change from baseline in AUC for blood glucose levels at each time points was calculated. |
| Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | Baseline, up to 28 days | Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated. |
| Standard Deviation (SD) of 24-hour Blood Glucose Values | Baseline, up to 28 days | — |
| Changes From Baseline in the SD of Daytime Blood Glucose Values | Baseline, up to 28 days | Change from baseline in SD of daytime blood glucose values at each time points was calculated. |
| Changes From Baseline in the SD of Nocturnal Blood Glucose Values | Baseline, up to 28 days | Change from baseline in SD of nocturnal blood glucose values at each time points was calculated. |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events | Up to 29 days | — |
| Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | Baseline, up to 28 days | Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 2 investigative sites in Japan, from 08 September 2016 to 27 April 2017.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in 1 of 2 (the trelagliptin 100 mg group or the alogliptin 25 mg group) treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Trelagliptin 100 mg Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast. | 13 |
| Alogliptin 25 mg Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast. | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Alogliptin 25 mg | Total | Trelagliptin 100 mg |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 7.64 | 62.7 years STANDARD_DEVIATION 8.76 | 62.8 years STANDARD_DEVIATION 10.14 |
| Alcohol Classification No | 12 Participants | 24 Participants | 12 Participants |
| Alcohol Classification Yes | 2 Participants | 3 Participants | 1 Participants |
| Area Under the Plasma Concentration-time Curve (AUC) of blood glucose | 46372.7 mg*min/dL STANDARD_DEVIATION 5282.47 | 44242.3 mg*min/dL STANDARD_DEVIATION 5553.22 | 41947.9 mg*min/dL STANDARD_DEVIATION 5058.5 |
| Body Mass Index (BMI) | 23.65 (kg/m^2) STANDARD_DEVIATION 2.404 | 24.52 (kg/m^2) STANDARD_DEVIATION 2.783 | 25.45 (kg/m^2) STANDARD_DEVIATION 2.948 |
| Duration of Diabetes Mellitus | 6.15 years STANDARD_DEVIATION 4.679 | 5.89 years STANDARD_DEVIATION 4.5 | 5.62 years STANDARD_DEVIATION 4.471 |
| Fasting Blood Glucose | 145.5 mg/dL STANDARD_DEVIATION 19.15 | 144.8 mg/dL STANDARD_DEVIATION 18.06 | 144.0 mg/dL STANDARD_DEVIATION 17.57 |
| Fasting Insulin | 8.79 uU/mL STANDARD_DEVIATION 4.395 | 9.09 uU/mL STANDARD_DEVIATION 4.221 | 9.42 uU/mL STANDARD_DEVIATION 4.177 |
| Glycated hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | 7.19 percent STANDARD_DEVIATION 0.339 | 7.24 percent STANDARD_DEVIATION 0.485 | 7.29 percent STANDARD_DEVIATION 0.616 |
| Height | 164.4 centimeter (cm) STANDARD_DEVIATION 7.17 | 162.7 centimeter (cm) STANDARD_DEVIATION 8.87 | 160.9 centimeter (cm) STANDARD_DEVIATION 10.4 |
| Mean 24-hour Blood Glucose | 161.01 mg/dL STANDARD_DEVIATION 18.349 | 153.62 mg/dL STANDARD_DEVIATION 19.287 | 145.65 mg/dL STANDARD_DEVIATION 17.57 |
| Mean Amplitude Glycemic Excursions (MAGE) | 114.91 millgrams per deciliter (mg/dL) STANDARD_DEVIATION 38.454 | 106.47 millgrams per deciliter (mg/dL) STANDARD_DEVIATION 41.488 | 98.02 millgrams per deciliter (mg/dL) STANDARD_DEVIATION 44.191 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Japan | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 7 Participants |
| Smoking Classification Current Smoker | 3 Participants | 6 Participants | 3 Participants |
| Smoking Classification Ex-Smoker | 4 Participants | 6 Participants | 2 Participants |
| Smoking Classification Never Smoked | 7 Participants | 15 Participants | 8 Participants |
| Weight | 64.15 kilogram (kg) STANDARD_DEVIATION 9.585 | 65.26 kilogram (kg) STANDARD_DEVIATION 11.796 | 66.45 kilogram (kg) STANDARD_DEVIATION 14.107 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 1 / 13 | 2 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 \[Day 22\] and Day 8 on Week 3 \[Day 28\]) of the treatment period, calculated from the value at the start of the observation period.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | Day(D) 2 Week(W) 3 | -7.51 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D3W3 | -11.76 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D4W3 | -11.71 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D5W3 | -9.89 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D6W3 | -12.75 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D7W3 | -9.50 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D8W3 | -7.35 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D5W3 | -13.28 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | Day(D) 2 Week(W) 3 | -13.04 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D7W3 | -10.90 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D3W3 | -15.24 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D6W3 | -11.94 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D4W3 | -12.91 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values | D8W3 | -11.63 mg/dL |
Secondary
Change From Baseline in AUC for Blood Glucose
Change from baseline in AUC for blood glucose levels at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose | D4W3 | -3723.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose | D6W3 | -2408.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose | D3W3 | -2348.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose | D7W3 | -1837.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose | D5W3 | -4017.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose | D8W3 | -2438.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose | D2W3 | -2340.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose | D8W3 | -4302.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose | D2W3 | -4828.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose | D3W3 | -3594.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose | D4W3 | -4565.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose | D5W3 | -5023.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose | D6W3 | -4526.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose | D7W3 | -4097.5 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D3W3 | -43.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D5W3 | -30.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D2W3 | -31.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D6W3 | -39.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D4W3 | -42.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D8W3 | -43.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D7W3 | -43.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D8W3 | 0.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D7W3 | 0.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D2W3 | 0.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D3W3 | 0.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D4W3 | 13.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D5W3 | 26.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) | D6W3 | 0.0 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D4W3 | -3755.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D6W3 | -2581.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D3W3 | -2479.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D7W3 | -2184.1 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D2W3 | -2263.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D8W3 | -2634.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D5W3 | -3845.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D8W3 | -4335.7 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D2W3 | -4735.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D4W3 | -4576.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D5W3 | -4812.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D6W3 | -4592.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D7W3 | -4169.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) | D3W3 | -3742.8 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D5W3 | -2981.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D8W3 | -2043.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D2W3 | -1935.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D6W3 | -2550.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D3W3 | -2001.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D4W3 | -2978.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D7W3 | -1946.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D8W3 | -3667.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D4W3 | -4119.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D6W3 | -3840.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D7W3 | -3566.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D2W3 | -4021.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D5W3 | -4230.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D3W3 | -3378.3 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D7W3 | -1636.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D8W3 | -1603.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D2W3 | -1458.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D3W3 | -1702.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D4W3 | -2335.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D5W3 | -2171.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D6W3 | -2031.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D4W3 | -3273.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D6W3 | -2990.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D7W3 | -2768.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D3W3 | -2767.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D8W3 | -2818.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D5W3 | -3384.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D2W3 | -3075.8 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D2W3 | -989.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D3W3 | -1332.7 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D8W3 | -1166.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D4W3 | -1685.1 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D5W3 | -1486.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D6W3 | -1449.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D7W3 | -1264.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D8W3 | -2009.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D2W3 | -2247.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D5W3 | -2492.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D3W3 | -2086.7 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D7W3 | -1976.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D6W3 | -2109.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D4W3 | -2352.2 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -573.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -1142.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -521.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -203.7 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -793.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -662.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -1079.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -1024.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -399.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -97.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -1273.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -696.1 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -798.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -669.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -1359.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -500.1 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -1199.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -320.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -468.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -1351.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -884.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -756.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -966.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -701.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -1065.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -534.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -488.7 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -923.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -800.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -1023.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -1144.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -669.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -577.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -1052.7 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -1030.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -958.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -1319.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -1024.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -1131.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -941.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -1228.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -832.5 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -218.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -510.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -886.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -21.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -559.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -457.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -348.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -588.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -489.7 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -429.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -725.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -707.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -294.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -474.7 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -950.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -1147.1 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -1147.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -964.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -1077.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -1030.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -822.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -970.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -981.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -637.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -926.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -517.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -801.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -613.7 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -1178.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -458.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -791.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -586.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -910.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -867.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -951.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -966.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -1079.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -862.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -845.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -535.0 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -648.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -1016.8 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -730.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -759.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -914.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -579.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -887.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -273.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -809.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -405.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -534.1 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -356.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -377.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -249.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -448.1 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -462.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -825.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | 25.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -350.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -742.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -389.7 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -763.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -164.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -460.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -829.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -770.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -609.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -981.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -890.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -705.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -552.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -811.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -469.7 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -384.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -730.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -507.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -808.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -508.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -696.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -760.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -806.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -671.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -759.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -504.1 mg·min/dL |
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -612.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -241.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -632.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | 36.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -272.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -214.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -307.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -430.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -353.5 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -184.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -234.0 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -507.6 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -592.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -662.4 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -641.9 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -598.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -90.7 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -264.2 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -300.3 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -383.8 mg·min/dL |
| Trelagliptin 100 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -555.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -374.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -660.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -375.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -592.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -776.3 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -375.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -484.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -346.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -556.5 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -597.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -603.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -521.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -578.2 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -404.1 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -427.8 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -589.9 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -354.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -552.4 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -293.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -626.6 mg·min/dL |
| Alogliptin 25 mg | Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -546.4 mg·min/dL |
Secondary
Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal
Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D8W3 between before/after breakfast | -36.2 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D7W3 between before/after breakfast | -36.4 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D7W3 between before/after lunch | -12.7 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D8W3 between before/after lunch | -15.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D2W3 between before/after evening meal | -37.8 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D3W3 between before/after evening meal | -49.1 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D4W3 between before/after evening meal | -42.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D5W3 between before/after evening meal | -31.5 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D6W3 between before/after evening meal | -41.9 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D7W3 between before/after evening meal | -33.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D8W3 between before/after evening meal | -39.3 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D2W3 between before/after breakfast | -13.9 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D3W3 between before/after breakfast | -47.4 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D4W3 between before/after breakfast | -41.2 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D5W3 between before/after breakfast | -7.0 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D6W3 between before/after breakfast | -38.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D2W3 between before/after lunch | -30.2 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D3W3 between before/after lunch | -34.5 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D4W3 between before/after lunch | -23.8 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D5W3 between before/after lunch | -34.8 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D6W3 between before/after lunch | -37.0 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D8W3 between before/after evening meal | -6.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D8W3 between before/after breakfast | -34.5 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D7W3 between before/after breakfast | -33.3 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D6W3 between before/after lunch | -13.1 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D2W3 between before/after breakfast | -28.9 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D7W3 between before/after lunch | -14.9 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D5W3 between before/after lunch | -31.2 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D8W3 between before/after lunch | -29.1 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D3W3 between before/after breakfast | -35.4 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D2W3 between before/after evening meal | -15.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D2W3 between before/after lunch | -35.5 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D3W3 between before/after evening meal | -21.8 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D4W3 between before/after breakfast | -42.1 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D4W3 between before/after evening meal | -24.2 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D4W3 between before/after lunch | -6.2 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D5W3 between before/after evening meal | -5.2 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D5W3 between before/after breakfast | -25.5 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D6W3 between before/after evening meal | -24.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D3W3 between before/after lunch | -29.5 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D7W3 between before/after evening meal | -4.4 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal | D6W3 between before/after breakfast | -29.8 mg/dL |
Secondary
Change From Baseline in Mean 24-hour Blood Glucose Levels
Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D2W3 | -8.14 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D4W3 | -13.12 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D7W3 | -6.38 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D5W3 | -13.95 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D3W3 | -8.15 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D8W3 | -8.46 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D6W3 | -8.37 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D8W3 | -14.94 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D6W3 | -15.79 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D7W3 | -14.23 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D2W3 | -16.77 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D3W3 | -12.46 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D4W3 | -15.85 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean 24-hour Blood Glucose Levels | D5W3 | -17.46 mg/dL |
Secondary
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
Change from baseline in MAGE at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D4W3 | -36.08 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D6W3 | -38.05 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D3W3 | -33.72 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D7W3 | -25.74 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D5W3 | -23.12 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D8W3 | -24.26 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D2W3 | -28.42 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D8W3 | -41.38 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D2W3 | -47.25 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D3W3 | -52.75 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D4W3 | -44.67 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D5W3 | -50.22 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D6W3 | -34.82 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) | D7W3 | -37.18 mg/dL |
Secondary
Change From Baseline in Mean Daytime Blood Glucose Levels
Change from baseline in mean daytime blood glucose levels at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D5W3 | -19.53 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D2W3 | -11.08 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D6W3 | -14.27 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D4W3 | -18.42 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D7W3 | -10.86 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D8W3 | -12.90 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D3W3 | -12.48 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D8W3 | -19.78 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D2W3 | -20.38 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D3W3 | -17.21 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D4W3 | -21.80 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D5W3 | -22.54 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D6W3 | -19.34 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Daytime Blood Glucose Levels | D7W3 | -16.92 mg/dL |
Secondary
Change From Baseline in Mean Nocturnal Blood Glucose Levels
Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D4W3 | -3.17 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D6W3 | 5.55 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D3W3 | 0.52 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D7W3 | 3.86 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D5W3 | -4.09 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D8W3 | 1.06 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D2W3 | -2.65 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D8W3 | -5.96 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D2W3 | -10.69 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D3W3 | -3.38 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D4W3 | -3.76 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D5W3 | -6.43 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D6W3 | -7.98 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Mean Nocturnal Blood Glucose Levels | D7W3 | -8.59 mg/dL |
Secondary
Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -25.9 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -40.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -21.9 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -39.4 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -34.8 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -17.7 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -32.7 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -4.9 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -11.5 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -42.2 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -44.5 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -28.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -45.8 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -11.3 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -40.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -16.6 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -41.5 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -23.7 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -32.3 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -26.9 mg/dL |
| Trelagliptin 100 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -35.4 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after evening meal | -15.9 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after lunch | -33.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after evening meal | -21.3 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after breakfast | -35.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after breakfast | -29.1 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after breakfast | -29.0 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after breakfast | -41.1 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after breakfast | -29.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D8W3 after breakfast | -31.4 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D2W3 after lunch | -40.8 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after lunch | -35.1 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after lunch | -16.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after lunch | -41.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after lunch | -18.7 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after lunch | -18.1 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D3W3 after evening meal | -21.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D4W3 after evening meal | -32.7 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D5W3 after evening meal | -15.6 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after evening meal | -33.8 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D7W3 after evening meal | -13.9 mg/dL |
| Alogliptin 25 mg | Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal | D6W3 after breakfast | -24.2 mg/dL |
Secondary
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D5W3 | -192.3 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D3W3 | -105.0 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D4W3 | -163.8 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D7W3 | -96.9 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D6W3 | -114.2 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D8W3 | -133.8 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D2W3 | -116.9 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D8W3 | -198.6 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D4W3 | -166.1 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D5W3 | -163.2 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D2W3 | -212.5 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D6W3 | -193.2 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D7W3 | -182.1 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) | D3W3 | -147.1 min |
Secondary
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D4W3 | -167.7 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D6W3 | -153.1 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D3W3 | -75.0 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D7W3 | -93.5 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D5W3 | -200.0 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D8W3 | -115.0 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D2W3 | -134.2 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D8W3 | -225.4 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D2W3 | -229.3 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D3W3 | -173.2 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D4W3 | -234.3 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D5W3 | -236.8 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D6W3 | -232.9 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) | D7W3 | -213.2 min |
Secondary
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D2W3 | -91.2 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D4W3 | -167.3 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D3W3 | -117.3 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D7W3 | -94.2 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D6W3 | -137.7 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D8W3 | -105.0 min |
| Trelagliptin 100 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D5W3 | -153.1 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D8W3 | -193.2 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D4W3 | -236.4 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D5W3 | -225.4 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D6W3 | -216.8 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D2W3 | -210.7 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D7W3 | -194.3 min |
| Alogliptin 25 mg | Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) | D3W3 | -167.1 min |
Secondary
Changes From Baseline in the SD of Daytime Blood Glucose Values
Change from baseline in SD of daytime blood glucose values at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D4W3 | -11.98 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D6W3 | -11.94 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D3W3 | -12.82 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D7W3 | -8.13 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D5W3 | -10.88 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D8W3 | -6.49 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D2W3 | -9.78 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D8W3 | -10.81 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D2W3 | -13.28 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D3W3 | -13.12 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D4W3 | -10.98 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D5W3 | -12.54 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D6W3 | -10.44 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Daytime Blood Glucose Values | D7W3 | -9.49 mg/dL |
Secondary
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D4W3 | -4.06 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D6W3 | -5.67 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D3W3 | -3.55 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D7W3 | -5.25 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D5W3 | -2.96 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D8W3 | -2.93 mg/dL |
| Trelagliptin 100 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D2W3 | -0.71 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D8W3 | -6.64 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D2W3 | -2.45 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D3W3 | -9.76 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D4W3 | -7.86 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D5W3 | -5.21 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D6W3 | -8.23 mg/dL |
| Alogliptin 25 mg | Changes From Baseline in the SD of Nocturnal Blood Glucose Values | D7W3 | -8.01 mg/dL |
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Time frame: Up to 29 days
Population: Safety Analysis Set (SAS), SAS was defined as participants who received at least one dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin 100 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events | 1 Participants |
| Alogliptin 25 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events | 2 Participants |
Secondary
Standard Deviation (SD) of 24-hour Blood Glucose Values
Time frame: Baseline, up to 28 days
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) |
|---|---|---|---|
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | Baseline | 38.18 mg/dL |
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D2W3 | 30.68 mg/dL |
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D3W3 | 26.42 mg/dL |
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D4W3 | 26.48 mg/dL |
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D5W3 | 28.29 mg/dL |
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D6W3 | 25.44 mg/dL |
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D7W3 | 28.68 mg/dL |
| Trelagliptin 100 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D8W3 | 30.84 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D8W3 | 28.81 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | Baseline | 40.44 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D5W3 | 27.16 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D2W3 | 27.41 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D7W3 | 29.54 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D3W3 | 25.20 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D6W3 | 28.51 mg/dL |
| Alogliptin 25 mg | Standard Deviation (SD) of 24-hour Blood Glucose Values | D4W3 | 27.54 mg/dL |