Trial Outcomes & Findings for An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus (NCT NCT02771093)
NCT ID: NCT02771093
Last Updated: 2023-12-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
Baseline, up to 28 days
Results posted on
2023-12-12
Participant Flow
Participants took part in the study at 2 investigative sites in Japan, from 08 September 2016 to 27 April 2017.
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.
Participant milestones
| Measure |
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 10.14 • n=13 Participants
|
62.7 years
STANDARD_DEVIATION 7.64 • n=14 Participants
|
62.7 years
STANDARD_DEVIATION 8.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=13 Participants
|
4 Participants
n=14 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=13 Participants
|
10 Participants
n=14 Participants
|
17 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
13 Participants
n=13 Participants
|
14 Participants
n=14 Participants
|
27 Participants
n=27 Participants
|
|
Height
|
160.9 centimeter (cm)
STANDARD_DEVIATION 10.40 • n=13 Participants
|
164.4 centimeter (cm)
STANDARD_DEVIATION 7.17 • n=14 Participants
|
162.7 centimeter (cm)
STANDARD_DEVIATION 8.87 • n=27 Participants
|
|
Weight
|
66.45 kilogram (kg)
STANDARD_DEVIATION 14.107 • n=13 Participants
|
64.15 kilogram (kg)
STANDARD_DEVIATION 9.585 • n=14 Participants
|
65.26 kilogram (kg)
STANDARD_DEVIATION 11.796 • n=27 Participants
|
|
Body Mass Index (BMI)
|
25.45 (kg/m^2)
STANDARD_DEVIATION 2.948 • n=13 Participants
|
23.65 (kg/m^2)
STANDARD_DEVIATION 2.404 • n=14 Participants
|
24.52 (kg/m^2)
STANDARD_DEVIATION 2.783 • n=27 Participants
|
|
Smoking Classification
Never Smoked
|
8 Participants
n=13 Participants
|
7 Participants
n=14 Participants
|
15 Participants
n=27 Participants
|
|
Smoking Classification
Current Smoker
|
3 Participants
n=13 Participants
|
3 Participants
n=14 Participants
|
6 Participants
n=27 Participants
|
|
Smoking Classification
Ex-Smoker
|
2 Participants
n=13 Participants
|
4 Participants
n=14 Participants
|
6 Participants
n=27 Participants
|
|
Alcohol Classification
Yes
|
1 Participants
n=13 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=27 Participants
|
|
Alcohol Classification
No
|
12 Participants
n=13 Participants
|
12 Participants
n=14 Participants
|
24 Participants
n=27 Participants
|
|
Duration of Diabetes Mellitus
|
5.62 years
STANDARD_DEVIATION 4.471 • n=13 Participants
|
6.15 years
STANDARD_DEVIATION 4.679 • n=14 Participants
|
5.89 years
STANDARD_DEVIATION 4.500 • n=27 Participants
|
|
Glycated hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]
|
7.29 percent
STANDARD_DEVIATION 0.616 • n=13 Participants
|
7.19 percent
STANDARD_DEVIATION 0.339 • n=14 Participants
|
7.24 percent
STANDARD_DEVIATION 0.485 • n=27 Participants
|
|
Mean Amplitude Glycemic Excursions (MAGE)
|
98.02 millgrams per deciliter (mg/dL)
STANDARD_DEVIATION 44.191 • n=13 Participants • The number analyzed is the number of participants with data available for analysis.
|
114.91 millgrams per deciliter (mg/dL)
STANDARD_DEVIATION 38.454 • n=13 Participants • The number analyzed is the number of participants with data available for analysis.
|
106.47 millgrams per deciliter (mg/dL)
STANDARD_DEVIATION 41.488 • n=26 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Mean 24-hour Blood Glucose
|
145.65 mg/dL
STANDARD_DEVIATION 17.570 • n=13 Participants
|
161.01 mg/dL
STANDARD_DEVIATION 18.349 • n=14 Participants
|
153.62 mg/dL
STANDARD_DEVIATION 19.287 • n=27 Participants
|
|
Area Under the Plasma Concentration-time Curve (AUC) of blood glucose
|
41947.9 mg*min/dL
STANDARD_DEVIATION 5058.50 • n=13 Participants
|
46372.7 mg*min/dL
STANDARD_DEVIATION 5282.47 • n=14 Participants
|
44242.3 mg*min/dL
STANDARD_DEVIATION 5553.22 • n=27 Participants
|
|
Fasting Insulin
|
9.42 uU/mL
STANDARD_DEVIATION 4.177 • n=13 Participants
|
8.79 uU/mL
STANDARD_DEVIATION 4.395 • n=14 Participants
|
9.09 uU/mL
STANDARD_DEVIATION 4.221 • n=27 Participants
|
|
Fasting Blood Glucose
|
144.0 mg/dL
STANDARD_DEVIATION 17.57 • n=13 Participants
|
145.5 mg/dL
STANDARD_DEVIATION 19.15 • n=14 Participants
|
144.8 mg/dL
STANDARD_DEVIATION 18.06 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
Day(D) 2 Week(W) 3
|
-7.51 mg/dL
Interval -17.1 to 2.08
|
-13.04 mg/dL
Interval -20.84 to -5.23
|
|
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
D3W3
|
-11.76 mg/dL
Interval -21.12 to -2.4
|
-15.24 mg/dL
Interval -21.87 to -8.61
|
|
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
D4W3
|
-11.71 mg/dL
Interval -21.84 to -1.58
|
-12.91 mg/dL
Interval -18.55 to -7.26
|
|
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
D5W3
|
-9.89 mg/dL
Interval -19.83 to 0.05
|
-13.28 mg/dL
Interval -21.28 to -5.27
|
|
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
D6W3
|
-12.75 mg/dL
Interval -22.01 to -3.49
|
-11.94 mg/dL
Interval -20.58 to -3.29
|
|
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
D7W3
|
-9.50 mg/dL
Interval -18.58 to -0.42
|
-10.90 mg/dL
Interval -20.0 to -1.8
|
|
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
D8W3
|
-7.35 mg/dL
Interval -15.13 to 0.44
|
-11.63 mg/dL
Interval -18.67 to -4.59
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -559.9 to 378.5
|
-660.1 mg·min/dL
Interval -1128.5 to -191.6
|
|
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
Interval -841.3 to 359.0
|
-592.9 mg·min/dL
Interval -1016.9 to -169.0
|
|
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
Interval -1357.8 to 93.4
|
-375.6 mg·min/dL
Interval -827.9 to 76.7
|
|
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
Interval -418.1 to 491.2
|
-776.3 mg·min/dL
Interval -1602.1 to 49.6
|
|
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
Interval -673.5 to 129.0
|
-556.5 mg·min/dL
Interval -1099.4 to -13.7
|
|
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
Interval -803.3 to 274.8
|
-578.2 mg·min/dL
Interval -1000.6 to -155.8
|
|
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
Interval -639.5 to 209.8
|
-603.6 mg·min/dL
Interval -1005.5 to -201.8
|
|
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
Interval -924.2 to 323.6
|
-626.6 mg·min/dL
Interval -1126.4 to -126.7
|
|
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
Interval -936.3 to 168.7
|
-521.1 mg·min/dL
Interval -1048.5 to 6.3
|
|
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
Interval -878.0 to 264.0
|
-404.1 mg·min/dL
Interval -890.6 to 82.3
|
|
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
Interval -989.5 to 128.7
|
-589.9 mg·min/dL
Interval -1093.1 to -86.6
|
|
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
Interval -859.1 to 152.2
|
-354.6 mg·min/dL
Interval -979.3 to 270.1
|
|
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
Interval -697.4 to 329.1
|
-293.6 mg·min/dL
Interval -923.6 to 336.3
|
|
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
Interval -767.7 to 299.7
|
-546.4 mg·min/dL
Interval -1085.4 to -7.4
|
|
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
Interval -1077.9 to 62.7
|
-375.9 mg·min/dL
Interval -841.4 to 89.7
|
|
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
Interval -1198.5 to 13.8
|
-484.4 mg·min/dL
Interval -1022.2 to 53.5
|
|
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
Interval -1251.3 to -73.4
|
-597.2 mg·min/dL
Interval -1070.4 to -124.0
|
|
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
Interval -1202.6 to -81.2
|
-427.8 mg·min/dL
Interval -1024.2 to 168.5
|
|
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
Interval -1183.3 to -14.4
|
-552.4 mg·min/dL
Interval -1101.3 to -3.5
|
|
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
Interval -1195.8 to -29.4
|
-374.5 mg·min/dL
Interval -1024.4 to 275.4
|
|
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
Interval -1128.7 to 17.9
|
-346.5 mg·min/dL
Interval -895.1 to 202.1
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -857.5 to 450.1
|
-1052.7 mg·min/dL
Interval -1596.7 to -508.7
|
|
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
Interval -1590.9 to 265.7
|
-1030.9 mg·min/dL
Interval -1538.5 to -523.4
|
|
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
Interval -2341.3 to 292.1
|
-958.9 mg·min/dL
Interval -1723.4 to -194.4
|
|
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
Interval -808.5 to 614.2
|
-1319.8 mg·min/dL
Interval -2358.8 to -280.7
|
|
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
Interval -1333.9 to -58.3
|
-832.5 mg·min/dL
Interval -1606.6 to -58.4
|
|
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
Interval -1309.2 to 161.5
|
-966.3 mg·min/dL
Interval -1566.5 to -366.0
|
|
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
Interval -1034.8 to 236.8
|
-1024.8 mg·min/dL
Interval -1550.4 to -499.2
|
|
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
Interval -1648.8 to 310.8
|
-1131.4 mg·min/dL
Interval -1738.4 to -524.5
|
|
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
Interval -1269.9 to 269.7
|
-941.9 mg·min/dL
Interval -1716.5 to -167.4
|
|
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
Interval -1272.1 to 335.6
|
-701.1 mg·min/dL
Interval -1330.5 to -71.8
|
|
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
Interval -1682.3 to 95.2
|
-1065.4 mg·min/dL
Interval -1736.4 to -394.3
|
|
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
Interval -1554.0 to -43.1
|
-534.4 mg·min/dL
Interval -1276.7 to 207.8
|
|
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
Interval -1078.0 to 437.2
|
-488.7 mg·min/dL
Interval -1297.0 to 319.6
|
|
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
Interval -1377.2 to 334.6
|
-923.5 mg·min/dL
Interval -1700.5 to -146.5
|
|
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
Interval -1793.3 to -365.4
|
-800.5 mg·min/dL
Interval -1381.4 to -219.6
|
|
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
Interval -2148.7 to -397.3
|
-1023.6 mg·min/dL
Interval -1676.2 to -371.1
|
|
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
Interval -2101.2 to -618.0
|
-1228.5 mg·min/dL
Interval -1793.6 to -663.4
|
|
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
Interval -2063.7 to -639.0
|
-756.1 mg·min/dL
Interval -1532.4 to 20.3
|
|
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
Interval -1847.4 to -552.4
|
-1144.2 mg·min/dL
Interval -1786.6 to -501.9
|
|
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
Interval -1659.0 to -109.3
|
-669.9 mg·min/dL
Interval -1432.0 to 92.1
|
|
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
Interval -2041.2 to -242.8
|
-577.0 mg·min/dL
Interval -1218.8 to 64.8
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -1561.4 to -83.2
|
-586.4 mg·min/dL
Interval -1346.1 to 173.4
|
|
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
Interval -1638.1 to -263.4
|
-637.6 mg·min/dL
Interval -1184.9 to -90.2
|
|
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
Interval -1902.8 to -251.8
|
-862.0 mg·min/dL
Interval -1508.7 to -215.3
|
|
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
Interval -1874.5 to -419.6
|
-1016.8 mg·min/dL
Interval -1565.1 to -468.4
|
|
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
Interval -1841.6 to -453.3
|
-613.7 mg·min/dL
Interval -1369.9 to 142.5
|
|
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
Interval -1668.4 to -392.8
|
-966.4 mg·min/dL
Interval -1594.0 to -338.7
|
|
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
Interval -1812.4 to -117.1
|
-535.0 mg·min/dL
Interval -1170.4 to 100.4
|
|
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
Interval -811.5 to 374.4
|
-981.2 mg·min/dL
Interval -1502.5 to -459.9
|
|
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
Interval -1377.6 to 357.2
|
-926.1 mg·min/dL
Interval -1418.1 to -434.2
|
|
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
Interval -1860.8 to 88.0
|
-801.6 mg·min/dL
Interval -1487.3 to -115.9
|
|
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
Interval -672.0 to 629.4
|
-1178.0 mg·min/dL
Interval -2185.7 to -170.3
|
|
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
Interval -1140.7 to 21.0
|
-791.8 mg·min/dL
Interval -1517.5 to -66.2
|
|
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
Interval -1154.7 to 239.9
|
-910.1 mg·min/dL
Interval -1492.1 to -328.1
|
|
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
Interval -942.4 to 245.5
|
-951.6 mg·min/dL
Interval -1450.0 to -453.1
|
|
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
Interval -1518.0 to 340.9
|
-1079.1 mg·min/dL
Interval -1649.8 to -508.5
|
|
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
Interval -1242.6 to 263.2
|
-845.4 mg·min/dL
Interval -1573.8 to -116.9
|
|
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
Interval -1195.4 to 336.8
|
-648.1 mg·min/dL
Interval -1253.9 to -42.3
|
|
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
Interval -1549.9 to 99.0
|
-970.0 mg·min/dL
Interval -1560.0 to -380.0
|
|
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
Interval -1383.0 to -32.9
|
-517.0 mg·min/dL
Interval -1245.9 to 211.9
|
|
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
Interval -1014.3 to 424.4
|
-458.3 mg·min/dL
Interval -1237.2 to 320.6
|
|
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
Interval -1254.4 to 305.0
|
-867.4 mg·min/dL
Interval -1598.8 to -135.9
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -704.0 to 374.9
|
-829.2 mg·min/dL
Interval -1327.2 to -331.2
|
|
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
Interval -1142.0 to 386.4
|
-770.4 mg·min/dL
Interval -1225.2 to -315.5
|
|
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
Interval -1568.6 to 49.8
|
-609.9 mg·min/dL
Interval -1198.1 to -21.7
|
|
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
Interval -546.2 to 597.5
|
-981.3 mg·min/dL
Interval -1918.9 to -43.6
|
|
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
Interval -912.4 to 101.5
|
-696.8 mg·min/dL
Interval -1340.7 to -53.0
|
|
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
Interval -1001.3 to 288.0
|
-760.4 mg·min/dL
Interval -1278.1 to -242.6
|
|
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
Interval -787.3 to 240.5
|
-806.3 mg·min/dL
Interval -1259.2 to -353.4
|
|
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
Interval -1249.4 to 353.2
|
-890.4 mg·min/dL
Interval -1433.1 to -347.7
|
|
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
Interval -1122.9 to 198.6
|
-705.5 mg·min/dL
Interval -1346.4 to -64.6
|
|
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
Interval -1066.5 to 287.1
|
-552.5 mg·min/dL
Interval -1109.1 to 4.1
|
|
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
Interval -1289.4 to 130.6
|
-811.9 mg·min/dL
Interval -1359.0 to -264.9
|
|
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
Interval -1126.5 to 58.4
|
-469.7 mg·min/dL
Interval -1161.5 to 222.1
|
|
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
Interval -884.3 to 384.4
|
-384.6 mg·min/dL
Interval -1104.5 to 335.3
|
|
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
Interval -1014.3 to 312.8
|
-730.1 mg·min/dL
Interval -1384.0 to -76.2
|
|
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
Interval -1380.6 to -80.3
|
-507.4 mg·min/dL
Interval -1016.6 to 1.9
|
|
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
Interval -1545.9 to -104.4
|
-671.1 mg·min/dL
Interval -1284.7 to -57.5
|
|
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
Interval -1611.8 to -217.2
|
-808.9 mg·min/dL
Interval -1337.7 to -280.2
|
|
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
Interval -1532.6 to -242.5
|
-508.3 mg·min/dL
Interval -1195.0 to 178.4
|
|
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
Interval -1436.6 to -182.4
|
-759.6 mg·min/dL
Interval -1361.2 to -157.9
|
|
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
Interval -1403.7 to -81.0
|
-504.1 mg·min/dL
Interval -1235.0 to 226.7
|
|
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
Interval -1480.9 to -45.8
|
-460.2 mg·min/dL
Interval -1059.2 to 138.8
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -4619.7 to 747.9
|
-4021.4 mg·min/dL
Interval -5867.0 to -2175.7
|
|
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
Interval -4861.6 to 859.3
|
-3378.3 mg·min/dL
Interval -6054.9 to -701.7
|
|
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
Interval -5095.6 to -860.8
|
-4119.9 mg·min/dL
Interval -5855.8 to -2384.1
|
|
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
Interval -5010.4 to -952.5
|
-4230.4 mg·min/dL
Interval -6524.2 to -1936.7
|
|
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
Interval -4308.5 to -792.4
|
-3840.0 mg·min/dL
Interval -6136.0 to -1544.0
|
|
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
Interval -3589.5 to -303.5
|
-3566.4 mg·min/dL
Interval -5763.1 to -1369.6
|
|
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
Interval -4237.3 to 150.4
|
-3667.1 mg·min/dL
Interval -5489.4 to -1844.7
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -3556.4 to 640.4
|
-3075.8 mg·min/dL
Interval -4672.5 to -1479.1
|
|
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
Interval -3893.0 to 489.0
|
-2767.3 mg·min/dL
Interval -4792.8 to -741.8
|
|
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
Interval -4011.2 to -660.3
|
-3273.0 mg·min/dL
Interval -4820.1 to -1725.9
|
|
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
Interval -3923.9 to -419.8
|
-3384.5 mg·min/dL
Interval -5073.8 to -1695.2
|
|
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
Interval -3588.9 to -473.1
|
-2990.8 mg·min/dL
Interval -4843.0 to -1138.6
|
|
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
Interval -3081.2 to -191.9
|
-2768.9 mg·min/dL
Interval -4705.6 to -832.1
|
|
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
Interval -3357.3 to 149.5
|
-2818.8 mg·min/dL
Interval -4272.4 to -1365.2
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -2508.3 to 528.4
|
-2247.9 mg·min/dL
Interval -3524.3 to -971.6
|
|
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
Interval -2948.0 to 282.6
|
-2086.7 mg·min/dL
Interval -3524.9 to -648.5
|
|
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
Interval -3054.1 to -316.0
|
-2352.2 mg·min/dL
Interval -3639.5 to -1065.0
|
|
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
Interval -2877.5 to -95.5
|
-2492.3 mg·min/dL
Interval -3775.9 to -1208.6
|
|
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
Interval -2803.7 to -95.0
|
-2109.1 mg·min/dL
Interval -3559.9 to -658.2
|
|
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
Interval -2516.7 to -11.8
|
-1976.3 mg·min/dL
Interval -3590.5 to -362.1
|
|
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
Interval -2536.5 to 202.8
|
-2009.8 mg·min/dL
Interval -3116.4 to -903.2
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
D2W3
|
-116.9 min
Interval -321.9 to 88.1
|
-212.5 min
Interval -326.5 to -98.5
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
D3W3
|
-105.0 min
Interval -318.1 to 108.1
|
-147.1 min
Interval -353.5 to 59.2
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
D4W3
|
-163.8 min
Interval -338.4 to 10.8
|
-166.1 min
Interval -312.4 to -19.8
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
D5W3
|
-192.3 min
Interval -363.7 to -20.9
|
-163.2 min
Interval -376.8 to 50.4
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
D6W3
|
-114.2 min
Interval -300.0 to 71.5
|
-193.2 min
Interval -370.9 to -15.6
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
D7W3
|
-96.9 min
Interval -243.3 to 49.5
|
-182.1 min
Interval -325.5 to -38.8
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
D8W3
|
-133.8 min
Interval -328.2 to 60.5
|
-198.6 min
Interval -348.0 to -49.2
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
D2W3
|
-134.2 min
Interval -315.6 to 47.1
|
-229.3 min
Interval -329.7 to -128.9
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
D3W3
|
-75.0 min
Interval -291.9 to 141.9
|
-173.2 min
Interval -356.0 to 9.6
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
D4W3
|
-167.7 min
Interval -322.8 to -12.6
|
-234.3 min
Interval -331.5 to -137.0
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
D5W3
|
-200.0 min
Interval -323.0 to -77.0
|
-236.8 min
Interval -389.3 to -84.2
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
D6W3
|
-153.1 min
Interval -287.4 to -18.7
|
-232.9 min
Interval -361.4 to -104.3
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
D7W3
|
-93.5 min
Interval -209.1 to 22.1
|
-213.2 min
Interval -328.9 to -97.5
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
D8W3
|
-115.0 min
Interval -255.6 to 25.6
|
-225.4 min
Interval -339.3 to -111.4
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
D2W3
|
-91.2 min
Interval -255.3 to 73.0
|
-210.7 min
Interval -315.9 to -105.6
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
D3W3
|
-117.3 min
Interval -271.7 to 37.1
|
-167.1 min
Interval -324.6 to -9.7
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
D4W3
|
-167.3 min
Interval -262.0 to -72.6
|
-236.4 min
Interval -339.0 to -133.8
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
D5W3
|
-153.1 min
Interval -273.6 to -32.6
|
-225.4 min
Interval -341.4 to -109.4
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
D6W3
|
-137.7 min
Interval -234.0 to -41.4
|
-216.8 min
Interval -336.1 to -97.5
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
D7W3
|
-94.2 min
Interval -185.2 to -3.2
|
-194.3 min
Interval -308.5 to -80.1
|
|
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
D8W3
|
-105.0 min
Interval -232.7 to 22.7
|
-193.2 min
Interval -290.5 to -96.0
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -105.8 to 43.3
|
0.4 mg·min/dL
Interval -0.4 to 1.1
|
|
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
Interval -136.3 to 50.3
|
0.0 mg·min/dL
Interval 0.0 to 0.0
|
|
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
Interval -135.8 to 51.2
|
13.4 mg·min/dL
Interval -14.0 to 40.8
|
|
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
Interval -129.9 to 68.8
|
26.9 mg·min/dL
Interval -8.9 to 62.6
|
|
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
Interval -134.0 to 54.3
|
0.0 mg·min/dL
Interval 0.0 to 0.0
|
|
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
Interval -136.3 to 50.3
|
0.0 mg·min/dL
Interval 0.0 to 0.0
|
|
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
Interval -136.3 to 50.3
|
0.0 mg·min/dL
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -45.9 to 23.3
|
-35.6 mg/dL
Interval -55.1 to -16.0
|
|
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
Interval -70.1 to -0.6
|
-29.1 mg/dL
Interval -50.0 to -8.1
|
|
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
Interval -86.6 to 7.8
|
-29.0 mg/dL
Interval -54.3 to -3.7
|
|
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
Interval -34.0 to 24.2
|
-41.1 mg/dL
Interval -70.3 to -11.9
|
|
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
Interval -51.9 to -5.4
|
-24.2 mg/dL
Interval -50.1 to 1.7
|
|
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
Interval -56.7 to 9.3
|
-29.6 mg/dL
Interval -51.6 to -7.5
|
|
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
Interval -44.6 to 11.4
|
-31.4 mg/dL
Interval -55.6 to -7.2
|
|
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
Interval -66.1 to 12.2
|
-40.8 mg/dL
Interval -63.8 to -17.8
|
|
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
Interval -55.8 to 3.9
|
-35.1 mg/dL
Interval -63.6 to -6.7
|
|
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
Interval -51.5 to 7.7
|
-16.6 mg/dL
Interval -42.6 to 9.3
|
|
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
Interval -67.4 to -2.2
|
-41.6 mg/dL
Interval -68.3 to -14.9
|
|
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
Interval -63.0 to -2.4
|
-18.7 mg/dL
Interval -50.8 to 13.4
|
|
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
Interval -44.7 to 21.8
|
-18.1 mg/dL
Interval -48.6 to 12.3
|
|
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
Interval -49.2 to 13.8
|
-33.6 mg/dL
Interval -63.7 to -3.6
|
|
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
Interval -68.4 to -12.9
|
-21.3 mg/dL
Interval -44.3 to 1.8
|
|
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
Interval -82.2 to -6.7
|
-21.6 mg/dL
Interval -45.0 to 1.7
|
|
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
Interval -78.6 to -13.0
|
-32.7 mg/dL
Interval -50.8 to -14.6
|
|
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
Interval -69.3 to -12.0
|
-15.6 mg/dL
Interval -43.2 to 12.0
|
|
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
Interval -68.0 to -15.0
|
-33.8 mg/dL
Interval -57.2 to -10.4
|
|
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
Interval -59.1 to -5.5
|
-13.9 mg/dL
Interval -42.8 to 15.0
|
|
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
Interval -73.3 to -11.2
|
-15.9 mg/dL
Interval -35.7 to 3.8
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: 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.
Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -51.7 to 23.8
|
-28.9 mg/dL
Interval -54.0 to -3.7
|
|
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
Interval -77.3 to -17.5
|
-35.4 mg/dL
Interval -57.6 to -13.1
|
|
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
Interval -77.7 to -4.7
|
-42.1 mg/dL
Interval -70.2 to -14.0
|
|
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
Interval -25.1 to 11.1
|
-25.5 mg/dL
Interval -55.6 to 4.6
|
|
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
Interval -65.9 to -11.4
|
-29.8 mg/dL
Interval -62.3 to 2.7
|
|
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
Interval -67.2 to -5.6
|
-33.3 mg/dL
Interval -58.2 to -8.4
|
|
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
Interval -61.0 to -11.3
|
-34.5 mg/dL
Interval -58.8 to -10.2
|
|
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
Interval -66.2 to 5.7
|
-35.5 mg/dL
Interval -64.4 to -6.6
|
|
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
Interval -68.9 to -0.1
|
-29.5 mg/dL
Interval -61.3 to 2.3
|
|
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
Interval -59.2 to 11.5
|
-6.2 mg/dL
Interval -39.1 to 26.6
|
|
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
Interval -73.8 to 4.2
|
-31.2 mg/dL
Interval -60.6 to -1.8
|
|
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
Interval -69.5 to -4.5
|
-13.1 mg/dL
Interval -50.6 to 24.4
|
|
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
Interval -49.6 to 24.2
|
-14.9 mg/dL
Interval -50.8 to 21.0
|
|
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
Interval -46.9 to 15.6
|
-29.1 mg/dL
Interval -68.9 to 10.7
|
|
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
Interval -75.3 to -0.3
|
-15.6 mg/dL
Interval -45.1 to 13.8
|
|
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
Interval -95.1 to -3.0
|
-21.8 mg/dL
Interval -48.6 to 5.0
|
|
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
Interval -86.1 to 0.8
|
-24.2 mg/dL
Interval -49.5 to 1.1
|
|
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
Interval -70.7 to 7.6
|
-5.2 mg/dL
Interval -39.1 to 28.7
|
|
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
Interval -73.8 to -10.1
|
-24.6 mg/dL
Interval -51.4 to 2.1
|
|
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
Interval -72.7 to 5.4
|
-4.4 mg/dL
Interval -36.6 to 27.9
|
|
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
Interval -75.5 to -3.1
|
-6.6 mg/dL
Interval -30.5 to 17.3
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: 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.
Change from baseline in MAGE at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
D2W3
|
-28.42 mg/dL
Interval -50.55 to -6.29
|
-47.25 mg/dL
Interval -77.78 to -16.71
|
|
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
D3W3
|
-33.72 mg/dL
Interval -60.42 to -7.03
|
-52.75 mg/dL
Interval -76.5 to -28.99
|
|
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
D4W3
|
-36.08 mg/dL
Interval -64.14 to -8.03
|
-44.67 mg/dL
Interval -69.51 to -19.83
|
|
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
D5W3
|
-23.12 mg/dL
Interval -45.68 to -0.56
|
-50.22 mg/dL
Interval -81.42 to -19.02
|
|
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
D6W3
|
-38.05 mg/dL
Interval -67.39 to -8.7
|
-34.82 mg/dL
Interval -62.54 to -7.09
|
|
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
D7W3
|
-25.74 mg/dL
Interval -48.52 to -2.96
|
-37.18 mg/dL
Interval -62.06 to -12.31
|
|
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
D8W3
|
-24.26 mg/dL
Interval -44.71 to -3.82
|
-41.38 mg/dL
Interval -66.75 to -16.01
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in Mean 24-hour Blood Glucose Levels
D2W3
|
-8.14 mg/dL
Interval -20.37 to 4.09
|
-16.77 mg/dL
Interval -23.33 to -10.21
|
|
Change From Baseline in Mean 24-hour Blood Glucose Levels
D3W3
|
-8.15 mg/dL
Interval -21.55 to 5.25
|
-12.46 mg/dL
Interval -23.07 to -1.86
|
|
Change From Baseline in Mean 24-hour Blood Glucose Levels
D4W3
|
-13.12 mg/dL
Interval -23.02 to -3.21
|
-15.85 mg/dL
Interval -23.57 to -8.13
|
|
Change From Baseline in Mean 24-hour Blood Glucose Levels
D5W3
|
-13.95 mg/dL
Interval -22.9 to -5.0
|
-17.46 mg/dL
Interval -27.9 to -7.03
|
|
Change From Baseline in Mean 24-hour Blood Glucose Levels
D6W3
|
-8.37 mg/dL
Interval -17.3 to 0.56
|
-15.79 mg/dL
Interval -24.43 to -7.14
|
|
Change From Baseline in Mean 24-hour Blood Glucose Levels
D7W3
|
-6.38 mg/dL
Interval -14.31 to 1.54
|
-14.23 mg/dL
Interval -22.0 to -6.46
|
|
Change From Baseline in Mean 24-hour Blood Glucose Levels
D8W3
|
-8.46 mg/dL
Interval -21.29 to 4.37
|
-14.94 mg/dL
Interval -21.97 to -7.9
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in mean daytime blood glucose levels at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in Mean Daytime Blood Glucose Levels
D2W3
|
-11.08 mg/dL
Interval -25.75 to 3.58
|
-20.38 mg/dL
Interval -28.27 to -12.48
|
|
Change From Baseline in Mean Daytime Blood Glucose Levels
D3W3
|
-12.48 mg/dL
Interval -26.87 to 1.91
|
-17.21 mg/dL
Interval -29.46 to -4.97
|
|
Change From Baseline in Mean Daytime Blood Glucose Levels
D4W3
|
-18.42 mg/dL
Interval -28.06 to -8.78
|
-21.80 mg/dL
Interval -31.2 to -12.4
|
|
Change From Baseline in Mean Daytime Blood Glucose Levels
D5W3
|
-19.53 mg/dL
Interval -29.75 to -9.31
|
-22.54 mg/dL
Interval -35.28 to -9.81
|
|
Change From Baseline in Mean Daytime Blood Glucose Levels
D6W3
|
-14.27 mg/dL
Interval -24.0 to -4.54
|
-19.34 mg/dL
Interval -29.1 to -9.59
|
|
Change From Baseline in Mean Daytime Blood Glucose Levels
D7W3
|
-10.86 mg/dL
Interval -20.48 to -1.25
|
-16.92 mg/dL
Interval -26.1 to -7.75
|
|
Change From Baseline in Mean Daytime Blood Glucose Levels
D8W3
|
-12.90 mg/dL
Interval -26.16 to 0.36
|
-19.78 mg/dL
Interval -28.28 to -11.27
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in Mean Nocturnal Blood Glucose Levels
D2W3
|
-2.65 mg/dL
Interval -17.2 to 11.89
|
-10.69 mg/dL
Interval -23.02 to 1.64
|
|
Change From Baseline in Mean Nocturnal Blood Glucose Levels
D3W3
|
0.52 mg/dL
Interval -15.45 to 16.48
|
-3.38 mg/dL
Interval -18.4 to 11.65
|
|
Change From Baseline in Mean Nocturnal Blood Glucose Levels
D4W3
|
-3.17 mg/dL
Interval -18.5 to 12.16
|
-3.76 mg/dL
Interval -15.4 to 7.89
|
|
Change From Baseline in Mean Nocturnal Blood Glucose Levels
D5W3
|
-4.09 mg/dL
Interval -16.58 to 8.4
|
-6.43 mg/dL
Interval -20.62 to 7.76
|
|
Change From Baseline in Mean Nocturnal Blood Glucose Levels
D6W3
|
5.55 mg/dL
Interval -6.57 to 17.68
|
-7.98 mg/dL
Interval -20.46 to 4.51
|
|
Change From Baseline in Mean Nocturnal Blood Glucose Levels
D7W3
|
3.86 mg/dL
Interval -4.41 to 12.13
|
-8.59 mg/dL
Interval -18.5 to 1.33
|
|
Change From Baseline in Mean Nocturnal Blood Glucose Levels
D8W3
|
1.06 mg/dL
Interval -13.04 to 15.16
|
-5.96 mg/dL
Interval -17.16 to 5.24
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in AUC for blood glucose levels at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Change From Baseline in AUC for Blood Glucose
D2W3
|
-2340.4 mg·min/dL
Interval -5859.6 to 1178.8
|
-4828.9 mg·min/dL
Interval -6716.3 to -2941.6
|
|
Change From Baseline in AUC for Blood Glucose
D3W3
|
-2348.4 mg·min/dL
Interval -6208.4 to 1511.6
|
-3594.8 mg·min/dL
Interval -6648.1 to -541.5
|
|
Change From Baseline in AUC for Blood Glucose
D4W3
|
-3723.2 mg·min/dL
Interval -6575.5 to -870.8
|
-4565.6 mg·min/dL
Interval -6788.3 to -2343.0
|
|
Change From Baseline in AUC for Blood Glucose
D5W3
|
-4017.8 mg·min/dL
Interval -6594.3 to -1441.4
|
-5023.4 mg·min/dL
Interval -8025.0 to -2021.8
|
|
Change From Baseline in AUC for Blood Glucose
D6W3
|
-2408.2 mg·min/dL
Interval -4978.6 to 162.3
|
-4526.4 mg·min/dL
Interval -7012.3 to -2040.6
|
|
Change From Baseline in AUC for Blood Glucose
D7W3
|
-1837.6 mg·min/dL
Interval -4117.9 to 442.7
|
-4097.5 mg·min/dL
Interval -6332.3 to -1862.7
|
|
Change From Baseline in AUC for Blood Glucose
D8W3
|
-2438.5 mg·min/dL
Interval -6134.2 to 1257.1
|
-4302.9 mg·min/dL
Interval -6327.4 to -2278.5
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
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
Interval -5522.2 to 994.7
|
-4735.1 mg·min/dL
Interval -6642.5 to -2827.7
|
|
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
Interval -6073.9 to 1115.4
|
-3742.8 mg·min/dL
Interval -6840.0 to -645.5
|
|
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
Interval -6409.6 to -1101.0
|
-4576.9 mg·min/dL
Interval -6710.1 to -2443.6
|
|
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
Interval -6396.3 to -1295.0
|
-4812.0 mg·min/dL
Interval -7716.0 to -1908.0
|
|
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
Interval -4877.8 to -286.0
|
-4592.1 mg·min/dL
Interval -7132.0 to -2052.3
|
|
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
Interval -4350.4 to -17.7
|
-4169.3 mg·min/dL
Interval -6477.7 to -1860.8
|
|
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
Interval -5836.3 to 568.0
|
-4335.7 mg·min/dL
Interval -6389.1 to -2282.4
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
Baseline
|
38.18 mg/dL
Interval 27.46 to 48.91
|
40.44 mg/dL
Interval 34.14 to 46.74
|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
D2W3
|
30.68 mg/dL
Interval 24.39 to 36.97
|
27.41 mg/dL
Interval 22.11 to 32.71
|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
D3W3
|
26.42 mg/dL
Interval 22.32 to 30.53
|
25.20 mg/dL
Interval 21.51 to 28.89
|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
D4W3
|
26.48 mg/dL
Interval 21.31 to 31.65
|
27.54 mg/dL
Interval 23.69 to 31.39
|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
D5W3
|
28.29 mg/dL
Interval 23.82 to 32.77
|
27.16 mg/dL
Interval 22.22 to 32.11
|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
D6W3
|
25.44 mg/dL
Interval 20.45 to 30.43
|
28.51 mg/dL
Interval 23.13 to 33.89
|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
D7W3
|
28.68 mg/dL
Interval 24.1 to 33.27
|
29.54 mg/dL
Interval 23.07 to 36.01
|
|
Standard Deviation (SD) of 24-hour Blood Glucose Values
D8W3
|
30.84 mg/dL
Interval 25.33 to 36.35
|
28.81 mg/dL
Interval 23.37 to 34.26
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in SD of daytime blood glucose values at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Changes From Baseline in the SD of Daytime Blood Glucose Values
D2W3
|
-9.78 mg/dL
Interval -19.01 to -0.54
|
-13.28 mg/dL
Interval -21.07 to -5.48
|
|
Changes From Baseline in the SD of Daytime Blood Glucose Values
D3W3
|
-12.82 mg/dL
Interval -23.36 to -2.29
|
-13.12 mg/dL
Interval -19.85 to -6.39
|
|
Changes From Baseline in the SD of Daytime Blood Glucose Values
D4W3
|
-11.98 mg/dL
Interval -22.91 to -1.04
|
-10.98 mg/dL
Interval -16.68 to -5.28
|
|
Changes From Baseline in the SD of Daytime Blood Glucose Values
D5W3
|
-10.88 mg/dL
Interval -21.93 to 0.18
|
-12.54 mg/dL
Interval -20.37 to -4.71
|
|
Changes From Baseline in the SD of Daytime Blood Glucose Values
D6W3
|
-11.94 mg/dL
Interval -21.55 to -2.33
|
-10.44 mg/dL
Interval -19.45 to -1.43
|
|
Changes From Baseline in the SD of Daytime Blood Glucose Values
D7W3
|
-8.13 mg/dL
Interval -17.7 to 1.44
|
-9.49 mg/dL
Interval -18.54 to -0.43
|
|
Changes From Baseline in the SD of Daytime Blood Glucose Values
D8W3
|
-6.49 mg/dL
Interval -14.98 to 2.0
|
-10.81 mg/dL
Interval -18.56 to -3.07
|
SECONDARY outcome
Timeframe: Baseline, up to 28 daysPopulation: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
D2W3
|
-0.71 mg/dL
Interval -7.36 to 5.95
|
-2.45 mg/dL
Interval -13.78 to 8.88
|
|
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
D3W3
|
-3.55 mg/dL
Interval -9.51 to 2.4
|
-9.76 mg/dL
Interval -18.48 to -1.03
|
|
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
D4W3
|
-4.06 mg/dL
Interval -13.05 to 4.92
|
-7.86 mg/dL
Interval -18.87 to 3.14
|
|
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
D5W3
|
-2.96 mg/dL
Interval -8.25 to 2.33
|
-5.21 mg/dL
Interval -16.82 to 6.39
|
|
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
D6W3
|
-5.67 mg/dL
Interval -12.26 to 0.93
|
-8.23 mg/dL
Interval -17.41 to 0.95
|
|
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
D7W3
|
-5.25 mg/dL
Interval -10.02 to -0.47
|
-8.01 mg/dL
Interval -17.17 to 1.16
|
|
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
D8W3
|
-2.93 mg/dL
Interval -9.26 to 3.4
|
-6.64 mg/dL
Interval -14.48 to 1.2
|
SECONDARY outcome
Timeframe: Up to 29 daysPopulation: Safety Analysis Set (SAS), SAS was defined as participants who received at least one dose of the study drug.
Outcome measures
| Measure |
Trelagliptin 100 mg
n=13 Participants
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
Alogliptin 25 mg
n=14 Participants
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events
|
1 Participants
|
2 Participants
|
Adverse Events
Alogliptin 25 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Trelagliptin 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alogliptin 25 mg
n=13 participants at risk
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
|
Trelagliptin 100 mg
n=14 participants at risk
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
|
|---|---|---|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.00%
0/13 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling abnormal
|
0.00%
0/13 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/13 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Up to 29 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Medical Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER