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NCT02771093: TRACK

An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus

Completed Phase 4 Results posted Last updated 12 December 2023
What this trial tests

Phase 4 trial testing Trelagliptin in Type 2 Diabetes Mellitus in 27 participants. Completed in 27 April 2017.

Timeline
8 September 2016
Primary endpoint
27 April 2017
27 April 2017

Quick facts

Lead sponsorTakeda
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment27
Start date8 September 2016
Primary completion27 April 2017
Estimated completion27 April 2017
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Takeda — full company profile →

Who can join

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 Values Primary · 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
GroupValue95% CI
Trelagliptin 100 mg-7.51-17.10 – 2.08
Alogliptin 25 mg-13.04-20.84 – -5.23
D3W3
GroupValue95% CI
Trelagliptin 100 mg-11.76-21.12 – -2.40
Alogliptin 25 mg-15.24-21.87 – -8.61
D4W3
GroupValue95% CI
Trelagliptin 100 mg-11.71-21.84 – -1.58
Alogliptin 25 mg-12.91-18.55 – -7.26
D5W3
GroupValue95% CI
Trelagliptin 100 mg-9.89-19.83 – 0.05
Alogliptin 25 mg-13.28-21.28 – -5.27
D6W3
GroupValue95% CI
Trelagliptin 100 mg-12.75-22.01 – -3.49
Alogliptin 25 mg-11.94-20.58 – -3.29
D7W3
GroupValue95% CI
Trelagliptin 100 mg-9.50-18.58 – -0.42
Alogliptin 25 mg-10.90-20.00 – -1.80
D8W3
GroupValue95% 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 Meal Secondary · 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
GroupValue95% CI
Trelagliptin 100 mg-90.7-559.9 – 378.5
Alogliptin 25 mg-660.1-1128.5 – -191.6
D3W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-241.2-841.3 – 359.0
Alogliptin 25 mg-592.9-1016.9 – -169.0
D4W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-632.2-1357.8 – 93.4
Alogliptin 25 mg-375.6-827.9 – 76.7
D5W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg36.5-418.1 – 491.2
Alogliptin 25 mg-776.3-1602.1 – 49.6
D6W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-272.2-673.5 – 129.0
Alogliptin 25 mg-556.5-1099.4 – -13.7
D7W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-264.2-803.3 – 274.8
Alogliptin 25 mg-578.2-1000.6 – -155.8
D8W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-214.8-639.5 – 209.8
Alogliptin 25 mg-603.6-1005.5 – -201.8
D2W3 after lunch
GroupValue95% 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 Meal Secondary · 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
GroupValue95% CI
Trelagliptin 100 mg-203.7-857.5 – 450.1
Alogliptin 25 mg-1052.7-1596.7 – -508.7
D3W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-662.6-1590.9 – 265.7
Alogliptin 25 mg-1030.9-1538.5 – -523.4
D4W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-1024.6-2341.3 – 292.1
Alogliptin 25 mg-958.9-1723.4 – -194.4
D5W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-97.2-808.5 – 614.2
Alogliptin 25 mg-1319.8-2358.8 – -280.7
D6W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-696.1-1333.9 – -58.3
Alogliptin 25 mg-832.5-1606.6 – -58.4
D7W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-573.8-1309.2 – 161.5
Alogliptin 25 mg-966.3-1566.5 – -366.0
D8W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-399.0-1034.8 – 236.8
Alogliptin 25 mg-1024.8-1550.4 – -499.2
D2W3 after lunch
GroupValue95% 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 Meal Secondary · 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
GroupValue95% CI
Trelagliptin 100 mg-218.5-811.5 – 374.4
Alogliptin 25 mg-981.2-1502.5 – -459.9
D3W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-510.2-1377.6 – 357.2
Alogliptin 25 mg-926.1-1418.1 – -434.2
D4W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-886.4-1860.8 – 88.0
Alogliptin 25 mg-801.6-1487.3 – -115.9
D5W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-21.3-672.0 – 629.4
Alogliptin 25 mg-1178.0-2185.7 – -170.3
D6W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-559.8-1140.7 – 21.0
Alogliptin 25 mg-791.8-1517.5 – -66.2
D7W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-457.4-1154.7 – 239.9
Alogliptin 25 mg-910.1-1492.1 – -328.1
D8W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-348.5-942.4 – 245.5
Alogliptin 25 mg-951.6-1450.0 – -453.1
D2W3 after lunch
GroupValue95% 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 Meal Secondary · 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
GroupValue95% CI
Trelagliptin 100 mg-164.5-704.0 – 374.9
Alogliptin 25 mg-829.2-1327.2 – -331.2
D3W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-377.8-1142.0 – 386.4
Alogliptin 25 mg-770.4-1225.2 – -315.5
D4W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-759.4-1568.6 – 49.8
Alogliptin 25 mg-609.9-1198.1 – -21.7
D5W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg25.6-546.2 – 597.5
Alogliptin 25 mg-981.3-1918.9 – -43.6
D6W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-405.5-912.4 – 101.5
Alogliptin 25 mg-696.8-1340.7 – -53.0
D7W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-356.6-1001.3 – 288.0
Alogliptin 25 mg-760.4-1278.1 – -242.6
D8W3 after breakfast
GroupValue95% CI
Trelagliptin 100 mg-273.4-787.3 – 240.5
Alogliptin 25 mg-806.3-1259.2 – -353.4
D2W3 after lunch
GroupValue95% 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
GroupValue95% CI
Trelagliptin 100 mg-1935.9-4619.7 – 747.9
Alogliptin 25 mg-4021.4-5867.0 – -2175.7
D3W3
GroupValue95% CI
Trelagliptin 100 mg-2001.2-4861.6 – 859.3
Alogliptin 25 mg-3378.3-6054.9 – -701.7
D4W3
GroupValue95% CI
Trelagliptin 100 mg-2978.2-5095.6 – -860.8
Alogliptin 25 mg-4119.9-5855.8 – -2384.1
D5W3
GroupValue95% CI
Trelagliptin 100 mg-2981.5-5010.4 – -952.5
Alogliptin 25 mg-4230.4-6524.2 – -1936.7
D6W3
GroupValue95% CI
Trelagliptin 100 mg-2550.5-4308.5 – -792.4
Alogliptin 25 mg-3840.0-6136.0 – -1544.0
D7W3
GroupValue95% CI
Trelagliptin 100 mg-1946.5-3589.5 – -303.5
Alogliptin 25 mg-3566.4-5763.1 – -1369.6
D8W3
GroupValue95% 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
GroupValue95% CI
Trelagliptin 100 mg-1458.0-3556.4 – 640.4
Alogliptin 25 mg-3075.8-4672.5 – -1479.1
D3W3
GroupValue95% CI
Trelagliptin 100 mg-1702.0-3893.0 – 489.0
Alogliptin 25 mg-2767.3-4792.8 – -741.8
D4W3
GroupValue95% CI
Trelagliptin 100 mg-2335.8-4011.2 – -660.3
Alogliptin 25 mg-3273.0-4820.1 – -1725.9
D5W3
GroupValue95% CI
Trelagliptin 100 mg-2171.8-3923.9 – -419.8
Alogliptin 25 mg-3384.5-5073.8 – -1695.2
D6W3
GroupValue95% CI
Trelagliptin 100 mg-2031.0-3588.9 – -473.1
Alogliptin 25 mg-2990.8-4843.0 – -1138.6
D7W3
GroupValue95% CI
Trelagliptin 100 mg-1636.5-3081.2 – -191.9
Alogliptin 25 mg-2768.9-4705.6 – -832.1
D8W3
GroupValue95% 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
GroupValue95% CI
Trelagliptin 100 mg-989.9-2508.3 – 528.4
Alogliptin 25 mg-2247.9-3524.3 – -971.6
D3W3
GroupValue95% CI
Trelagliptin 100 mg-1332.7-2948.0 – 282.6
Alogliptin 25 mg-2086.7-3524.9 – -648.5
D4W3
GroupValue95% CI
Trelagliptin 100 mg-1685.1-3054.1 – -316.0
Alogliptin 25 mg-2352.2-3639.5 – -1065.0
D5W3
GroupValue95% CI
Trelagliptin 100 mg-1486.5-2877.5 – -95.5
Alogliptin 25 mg-2492.3-3775.9 – -1208.6
D6W3
GroupValue95% CI
Trelagliptin 100 mg-1449.4-2803.7 – -95.0
Alogliptin 25 mg-2109.1-3559.9 – -658.2
D7W3
GroupValue95% CI
Trelagliptin 100 mg-1264.2-2516.7 – -11.8
Alogliptin 25 mg-1976.3-3590.5 – -362.1
D8W3
GroupValue95% 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
GroupValue95% CI
Trelagliptin 100 mg-116.9-321.9 – 88.1
Alogliptin 25 mg-212.5-326.5 – -98.5
D3W3
GroupValue95% CI
Trelagliptin 100 mg-105.0-318.1 – 108.1
Alogliptin 25 mg-147.1-353.5 – 59.2
D4W3
GroupValue95% CI
Trelagliptin 100 mg-163.8-338.4 – 10.8
Alogliptin 25 mg-166.1-312.4 – -19.8
D5W3
GroupValue95% CI
Trelagliptin 100 mg-192.3-363.7 – -20.9
Alogliptin 25 mg-163.2-376.8 – 50.4
D6W3
GroupValue95% CI
Trelagliptin 100 mg-114.2-300.0 – 71.5
Alogliptin 25 mg-193.2-370.9 – -15.6
D7W3
GroupValue95% CI
Trelagliptin 100 mg-96.9-243.3 – 49.5
Alogliptin 25 mg-182.1-325.5 – -38.8
D8W3
GroupValue95% 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
GroupValue95% CI
Trelagliptin 100 mg-134.2-315.6 – 47.1
Alogliptin 25 mg-229.3-329.7 – -128.9
D3W3
GroupValue95% CI
Trelagliptin 100 mg-75.0-291.9 – 141.9
Alogliptin 25 mg-173.2-356.0 – 9.6
D4W3
GroupValue95% CI
Trelagliptin 100 mg-167.7-322.8 – -12.6
Alogliptin 25 mg-234.3-331.5 – -137.0
D5W3
GroupValue95% CI
Trelagliptin 100 mg-200.0-323.0 – -77.0
Alogliptin 25 mg-236.8-389.3 – -84.2
D6W3
GroupValue95% CI
Trelagliptin 100 mg-153.1-287.4 – -18.7
Alogliptin 25 mg-232.9-361.4 – -104.3
D7W3
GroupValue95% CI
Trelagliptin 100 mg-93.5-209.1 – 22.1
Alogliptin 25 mg-213.2-328.9 – -97.5
D8W3
GroupValue95% 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
GroupValue95% CI
Trelagliptin 100 mg-91.2-255.3 – 73.0
Alogliptin 25 mg-210.7-315.9 – -105.6
D3W3
GroupValue95% CI
Trelagliptin 100 mg-117.3-271.7 – 37.1
Alogliptin 25 mg-167.1-324.6 – -9.7
D4W3
GroupValue95% CI
Trelagliptin 100 mg-167.3-262.0 – -72.6
Alogliptin 25 mg-236.4-339.0 – -133.8
D5W3
GroupValue95% CI
Trelagliptin 100 mg-153.1-273.6 – -32.6
Alogliptin 25 mg-225.4-341.4 – -109.4
D6W3
GroupValue95% CI
Trelagliptin 100 mg-137.7-234.0 – -41.4
Alogliptin 25 mg-216.8-336.1 – -97.5
D7W3
GroupValue95% CI
Trelagliptin 100 mg-94.2-185.2 – -3.2
Alogliptin 25 mg-194.3-308.5 – -80.1
D8W3
GroupValue95% 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
GroupValue95% CI
Trelagliptin 100 mg-31.2-105.8 – 43.3
Alogliptin 25 mg0.4-0.4 – 1.1
D3W3
GroupValue95% CI
Trelagliptin 100 mg-43.0-136.3 – 50.3
Alogliptin 25 mg0.00.0 – 0.0
D4W3
GroupValue95% CI
Trelagliptin 100 mg-42.3-135.8 – 51.2
Alogliptin 25 mg13.4-14.0 – 40.8
D5W3
GroupValue95% CI
Trelagliptin 100 mg-30.5-129.9 – 68.8
Alogliptin 25 mg26.9-8.9 – 62.6
D6W3
GroupValue95% CI
Trelagliptin 100 mg-39.8-134.0 – 54.3
Alogliptin 25 mg0.00.0 – 0.0
D7W3
GroupValue95% CI
Trelagliptin 100 mg-43.0-136.3 – 50.3
Alogliptin 25 mg0.00.0 – 0.0
D8W3
GroupValue95% CI
Trelagliptin 100 mg-43.0-136.3 – 50.3
Alogliptin 25 mg0.00.0 – 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.

Alogliptin 25 mg
Serious: 0/13 (0%)
Deaths: 0/13
Trelagliptin 100 mg
Serious: 0/14 (0%)
Deaths: 0/14
Other adverse events (5 terms — click to expand)

ReactionSystemAlogliptin 25 mgTrelagliptin 100 mg
Gastric mucosal lesionGastrointestinal disorders
Feeling abnormalGeneral disorders
Viral upper respiratory tract infectionInfections and infestations
DizzinessNervous system disorders
EczemaSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT02771093 adverse events section.

Sponsor's own description

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):

  1. Signaling pathways and intervention for therapy of type 2 diabetes mellitus.
    Cao R, Tian H, Zhang Y, Liu G, et al · · 2023 · cited 30× · PMID 37303813 · DOI 10.1002/mco2.283
  2. A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes.
    Nishimura R, Osonoi T, Koike Y, Miyata K, et al · · 2019 · cited 13× · PMID 31562608 · DOI 10.1007/s12325-019-01097-z

Verify or expand the search:

Other trials of Trelagliptin

Trials testing the same drug.

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Other Takeda trials

Trials by the same sponsor.

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Data sources for this page

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.

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