20 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose ValuesPrimary· 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.
Day(D) 2 Week(W) 3
Group
Value
95% CI
Trelagliptin 100 mg
-7.51
-17.10 – 2.08
Alogliptin 25 mg
-13.04
-20.84 – -5.23
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-11.76
-21.12 – -2.40
Alogliptin 25 mg
-15.24
-21.87 – -8.61
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-11.71
-21.84 – -1.58
Alogliptin 25 mg
-12.91
-18.55 – -7.26
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-9.89
-19.83 – 0.05
Alogliptin 25 mg
-13.28
-21.28 – -5.27
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-12.75
-22.01 – -3.49
Alogliptin 25 mg
-11.94
-20.58 – -3.29
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-9.50
-18.58 – -0.42
Alogliptin 25 mg
-10.90
-20.00 – -1.80
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-7.35
-15.13 – 0.44
Alogliptin 25 mg
-11.63
-18.67 – -4.59
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 MealSecondary· 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.
D2W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-90.7
-559.9 – 378.5
Alogliptin 25 mg
-660.1
-1128.5 – -191.6
D3W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-241.2
-841.3 – 359.0
Alogliptin 25 mg
-592.9
-1016.9 – -169.0
D4W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-632.2
-1357.8 – 93.4
Alogliptin 25 mg
-375.6
-827.9 – 76.7
D5W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
36.5
-418.1 – 491.2
Alogliptin 25 mg
-776.3
-1602.1 – 49.6
D6W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-272.2
-673.5 – 129.0
Alogliptin 25 mg
-556.5
-1099.4 – -13.7
D7W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-264.2
-803.3 – 274.8
Alogliptin 25 mg
-578.2
-1000.6 – -155.8
D8W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-214.8
-639.5 – 209.8
Alogliptin 25 mg
-603.6
-1005.5 – -201.8
D2W3 after lunch
Group
Value
95% CI
Trelagliptin 100 mg
-300.3
-924.2 – 323.6
Alogliptin 25 mg
-626.6
-1126.4 – -126.7
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 MealSecondary· 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.
D2W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-203.7
-857.5 – 450.1
Alogliptin 25 mg
-1052.7
-1596.7 – -508.7
D3W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-662.6
-1590.9 – 265.7
Alogliptin 25 mg
-1030.9
-1538.5 – -523.4
D4W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-1024.6
-2341.3 – 292.1
Alogliptin 25 mg
-958.9
-1723.4 – -194.4
D5W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-97.2
-808.5 – 614.2
Alogliptin 25 mg
-1319.8
-2358.8 – -280.7
D6W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-696.1
-1333.9 – -58.3
Alogliptin 25 mg
-832.5
-1606.6 – -58.4
D7W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-573.8
-1309.2 – 161.5
Alogliptin 25 mg
-966.3
-1566.5 – -366.0
D8W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-399.0
-1034.8 – 236.8
Alogliptin 25 mg
-1024.8
-1550.4 – -499.2
D2W3 after lunch
Group
Value
95% CI
Trelagliptin 100 mg
-669.0
-1648.8 – 310.8
Alogliptin 25 mg
-1131.4
-1738.4 – -524.5
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 MealSecondary· 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.
D2W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-218.5
-811.5 – 374.4
Alogliptin 25 mg
-981.2
-1502.5 – -459.9
D3W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-510.2
-1377.6 – 357.2
Alogliptin 25 mg
-926.1
-1418.1 – -434.2
D4W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-886.4
-1860.8 – 88.0
Alogliptin 25 mg
-801.6
-1487.3 – -115.9
D5W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-21.3
-672.0 – 629.4
Alogliptin 25 mg
-1178.0
-2185.7 – -170.3
D6W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-559.8
-1140.7 – 21.0
Alogliptin 25 mg
-791.8
-1517.5 – -66.2
D7W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-457.4
-1154.7 – 239.9
Alogliptin 25 mg
-910.1
-1492.1 – -328.1
D8W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-348.5
-942.4 – 245.5
Alogliptin 25 mg
-951.6
-1450.0 – -453.1
D2W3 after lunch
Group
Value
95% CI
Trelagliptin 100 mg
-588.5
-1518.0 – 340.9
Alogliptin 25 mg
-1079.1
-1649.8 – -508.5
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 MealSecondary· 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.
D2W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-164.5
-704.0 – 374.9
Alogliptin 25 mg
-829.2
-1327.2 – -331.2
D3W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-377.8
-1142.0 – 386.4
Alogliptin 25 mg
-770.4
-1225.2 – -315.5
D4W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-759.4
-1568.6 – 49.8
Alogliptin 25 mg
-609.9
-1198.1 – -21.7
D5W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
25.6
-546.2 – 597.5
Alogliptin 25 mg
-981.3
-1918.9 – -43.6
D6W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-405.5
-912.4 – 101.5
Alogliptin 25 mg
-696.8
-1340.7 – -53.0
D7W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-356.6
-1001.3 – 288.0
Alogliptin 25 mg
-760.4
-1278.1 – -242.6
D8W3 after breakfast
Group
Value
95% CI
Trelagliptin 100 mg
-273.4
-787.3 – 240.5
Alogliptin 25 mg
-806.3
-1259.2 – -353.4
D2W3 after lunch
Group
Value
95% CI
Trelagliptin 100 mg
-448.1
-1249.4 – 353.2
Alogliptin 25 mg
-890.4
-1433.1 – -347.7
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)Secondary· 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.
D2W3
Group
Value
95% CI
Trelagliptin 100 mg
-1935.9
-4619.7 – 747.9
Alogliptin 25 mg
-4021.4
-5867.0 – -2175.7
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-2001.2
-4861.6 – 859.3
Alogliptin 25 mg
-3378.3
-6054.9 – -701.7
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-2978.2
-5095.6 – -860.8
Alogliptin 25 mg
-4119.9
-5855.8 – -2384.1
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-2981.5
-5010.4 – -952.5
Alogliptin 25 mg
-4230.4
-6524.2 – -1936.7
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-2550.5
-4308.5 – -792.4
Alogliptin 25 mg
-3840.0
-6136.0 – -1544.0
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-1946.5
-3589.5 – -303.5
Alogliptin 25 mg
-3566.4
-5763.1 – -1369.6
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-2043.5
-4237.3 – 150.4
Alogliptin 25 mg
-3667.1
-5489.4 – -1844.7
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)Secondary· 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.
D2W3
Group
Value
95% CI
Trelagliptin 100 mg
-1458.0
-3556.4 – 640.4
Alogliptin 25 mg
-3075.8
-4672.5 – -1479.1
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-1702.0
-3893.0 – 489.0
Alogliptin 25 mg
-2767.3
-4792.8 – -741.8
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-2335.8
-4011.2 – -660.3
Alogliptin 25 mg
-3273.0
-4820.1 – -1725.9
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-2171.8
-3923.9 – -419.8
Alogliptin 25 mg
-3384.5
-5073.8 – -1695.2
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-2031.0
-3588.9 – -473.1
Alogliptin 25 mg
-2990.8
-4843.0 – -1138.6
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-1636.5
-3081.2 – -191.9
Alogliptin 25 mg
-2768.9
-4705.6 – -832.1
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-1603.9
-3357.3 – 149.5
Alogliptin 25 mg
-2818.8
-4272.4 – -1365.2
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)Secondary· 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.
D2W3
Group
Value
95% CI
Trelagliptin 100 mg
-989.9
-2508.3 – 528.4
Alogliptin 25 mg
-2247.9
-3524.3 – -971.6
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-1332.7
-2948.0 – 282.6
Alogliptin 25 mg
-2086.7
-3524.9 – -648.5
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-1685.1
-3054.1 – -316.0
Alogliptin 25 mg
-2352.2
-3639.5 – -1065.0
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-1486.5
-2877.5 – -95.5
Alogliptin 25 mg
-2492.3
-3775.9 – -1208.6
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-1449.4
-2803.7 – -95.0
Alogliptin 25 mg
-2109.1
-3559.9 – -658.2
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-1264.2
-2516.7 – -11.8
Alogliptin 25 mg
-1976.3
-3590.5 – -362.1
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-1166.8
-2536.5 – 202.8
Alogliptin 25 mg
-2009.8
-3116.4 – -903.2
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)Secondary· 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.
D2W3
Group
Value
95% CI
Trelagliptin 100 mg
-116.9
-321.9 – 88.1
Alogliptin 25 mg
-212.5
-326.5 – -98.5
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-105.0
-318.1 – 108.1
Alogliptin 25 mg
-147.1
-353.5 – 59.2
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-163.8
-338.4 – 10.8
Alogliptin 25 mg
-166.1
-312.4 – -19.8
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-192.3
-363.7 – -20.9
Alogliptin 25 mg
-163.2
-376.8 – 50.4
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-114.2
-300.0 – 71.5
Alogliptin 25 mg
-193.2
-370.9 – -15.6
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-96.9
-243.3 – 49.5
Alogliptin 25 mg
-182.1
-325.5 – -38.8
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-133.8
-328.2 – 60.5
Alogliptin 25 mg
-198.6
-348.0 – -49.2
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)Secondary· 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.
D2W3
Group
Value
95% CI
Trelagliptin 100 mg
-134.2
-315.6 – 47.1
Alogliptin 25 mg
-229.3
-329.7 – -128.9
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-75.0
-291.9 – 141.9
Alogliptin 25 mg
-173.2
-356.0 – 9.6
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-167.7
-322.8 – -12.6
Alogliptin 25 mg
-234.3
-331.5 – -137.0
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-200.0
-323.0 – -77.0
Alogliptin 25 mg
-236.8
-389.3 – -84.2
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-153.1
-287.4 – -18.7
Alogliptin 25 mg
-232.9
-361.4 – -104.3
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-93.5
-209.1 – 22.1
Alogliptin 25 mg
-213.2
-328.9 – -97.5
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-115.0
-255.6 – 25.6
Alogliptin 25 mg
-225.4
-339.3 – -111.4
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)Secondary· 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.
D2W3
Group
Value
95% CI
Trelagliptin 100 mg
-91.2
-255.3 – 73.0
Alogliptin 25 mg
-210.7
-315.9 – -105.6
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-117.3
-271.7 – 37.1
Alogliptin 25 mg
-167.1
-324.6 – -9.7
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-167.3
-262.0 – -72.6
Alogliptin 25 mg
-236.4
-339.0 – -133.8
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-153.1
-273.6 – -32.6
Alogliptin 25 mg
-225.4
-341.4 – -109.4
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-137.7
-234.0 – -41.4
Alogliptin 25 mg
-216.8
-336.1 – -97.5
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-94.2
-185.2 – -3.2
Alogliptin 25 mg
-194.3
-308.5 – -80.1
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-105.0
-232.7 – 22.7
Alogliptin 25 mg
-193.2
-290.5 – -96.0
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)Secondary· 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.
D2W3
Group
Value
95% CI
Trelagliptin 100 mg
-31.2
-105.8 – 43.3
Alogliptin 25 mg
0.4
-0.4 – 1.1
D3W3
Group
Value
95% CI
Trelagliptin 100 mg
-43.0
-136.3 – 50.3
Alogliptin 25 mg
0.0
0.0 – 0.0
D4W3
Group
Value
95% CI
Trelagliptin 100 mg
-42.3
-135.8 – 51.2
Alogliptin 25 mg
13.4
-14.0 – 40.8
D5W3
Group
Value
95% CI
Trelagliptin 100 mg
-30.5
-129.9 – 68.8
Alogliptin 25 mg
26.9
-8.9 – 62.6
D6W3
Group
Value
95% CI
Trelagliptin 100 mg
-39.8
-134.0 – 54.3
Alogliptin 25 mg
0.0
0.0 – 0.0
D7W3
Group
Value
95% CI
Trelagliptin 100 mg
-43.0
-136.3 – 50.3
Alogliptin 25 mg
0.0
0.0 – 0.0
D8W3
Group
Value
95% CI
Trelagliptin 100 mg
-43.0
-136.3 – 50.3
Alogliptin 25 mg
0.0
0.0 – 0.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 29 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04285983 — Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Sev
· completed
NCT04374864 — Dose Modification Requirement for Trelagliptin in Egyptian Population
· Phase 4
· unknown
NCT03231709 — Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants
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NCT03014479 — Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus
· Phase 4
· completed
NCT03555591 — Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 12 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02771093.