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

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02771093
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Trelagliptin; Drug: Alogliptin	Phase 4

Detailed Description

The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Sep 8, 2016
• Actual Primary Completion Date: Apr 27, 2017
• Actual Study Completion Date: Apr 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trelagliptin 100 mg group Trelagliptin 100 mg once weekly taken orally before breakfast	Drug: Trelagliptin; Trelagliptin 100 mg tablet
Experimental: Alogliptin 25 mg group Alogliptin 25 mg once daily taken orally before breakfast	Drug: Alogliptin; Alogliptin 25 mg tablet

Outcome Measures

Primary Outcome Measures

1. Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values [Baseline, up to 28 days]

   Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.

Secondary Outcome Measures

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 [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.

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 [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.

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 [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.

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 [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.

5. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) [Baseline, up to 28 days]

   Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.

6. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) [Baseline, up to 28 days]

   Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.

7. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) [Baseline, up to 28 days]

   Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.

8. Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia) [Baseline, up to 28 days]

   Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.

9. Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia) [Baseline, up to 28 days]

   Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.

10. Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia) [Baseline, up to 28 days]

    Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.

11. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia) [Baseline, up to 28 days]

    Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated.

12. Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal [Baseline, up to 28 days]

    Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.

13. Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal [Baseline, up to 28 days]

    Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.

14. Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE) [Baseline, up to 28 days]

    Change from baseline in MAGE at each time points was calculated.

15. Change From Baseline in Mean 24-hour Blood Glucose Levels [Baseline, up to 28 days]

    Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.

16. Change From Baseline in Mean Daytime Blood Glucose Levels [Baseline, up to 28 days]

    Change from baseline in mean daytime blood glucose levels at each time points was calculated.

17. Change From Baseline in Mean Nocturnal Blood Glucose Levels [Baseline, up to 28 days]

    Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.

18. Change From Baseline in AUC for Blood Glucose [Baseline, up to 28 days]

    Change from baseline in AUC for blood glucose levels at each time points was calculated.

19. Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia) [Baseline, up to 28 days]

    Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.

20. Standard Deviation (SD) of 24-hour Blood Glucose Values [Baseline, up to 28 days]

21. Changes From Baseline in the SD of Daytime Blood Glucose Values [Baseline, up to 28 days]

    Change from baseline in SD of daytime blood glucose values at each time points was calculated.

22. Changes From Baseline in the SD of Nocturnal Blood Glucose Values [Baseline, up to 28 days]

    Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.

23. Number of Participants Reporting One or More Treatment-emergent Adverse Events [Up to 29 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.

2. Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.

3. Participants diagnosed with type 2 diabetes mellitus.

4. Participants with a glycated hemoglobin (HbA1c) [National Glycohemoglobin Standardization Program (NGSP value)] value ≥ 6.5% and < 8.5% at the start of the observation period (Day -2).

5. Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks.

6. Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period.

7. Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period.

8. Men or women aged 20 years or older at the time of informed consent.

Exclusion Criteria:

1. Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.

2. Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period.

3. Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period [Day -2]).

4. Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance < 50 mL/min or serum creatinine > 1.4 mg/dL in men or > 1.2 mg/dL in women [equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg] at the start of the observation period [Day -2]).

5. Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.

6. Participants with a history of gastric or small intestinal resection.

7. Participants with proliferative diabetic retinopathy.

8. Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma).

9. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.

10. Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).

11. Participants with any malignant tumors.

12. Habitual drinkers whose average daily alcohol consumption is > 100 mL.

13. Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.

14. Participants anticipated to require any prohibited concomitant medications during the study period.

15. Participants who are day and night lifestyle reversal.

16. Participants participating in any other clinical studies at the time of informed consent for this study.

17. Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.

18. Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Naka-city	Ibaragi	Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

• Study Protocol - Feb 16, 2017
• Statistical Analysis Plan - Oct 25, 2017

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02771093
• Other Study ID Numbers: Trelagliptin-4001; U1111-1182-4062; JapicCTI-163250
• First Posted: May 12, 2016
• Last Update Posted: Jan 4, 2019
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Takeda: Type 2, Diabetes, Diabetes Mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Alogliptin

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 2 investigative sites in Japan, from 08 September 2016 to 27 April 2017.
Pre-assignment Detail	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.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Period Title: Overall Study
STARTED	13	14
COMPLETED	13	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg	Total
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.	Total of all reporting groups
Overall Participants	13	14	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.8 (10.14)	62.7 (7.64)	62.7 (8.76)
Sex: Female, Male (Count of Participants)
Female	6 46.2%	4 28.6%	10 37%
Male	7 53.8%	10 71.4%	17 63%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Number) [Number]
Japan	13 100%	14 100%	27 100%
Height (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]	160.9 (10.40)	164.4 (7.17)	162.7 (8.87)
Weight (kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram (kg)]	66.45 (14.107)	64.15 (9.585)	65.26 (11.796)
Body Mass Index (BMI) ((kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [(kg/m^2)]	25.45 (2.948)	23.65 (2.404)	24.52 (2.783)
Smoking Classification (Count of Participants)
Never Smoked	8 61.5%	7 50%	15 55.6%
Current Smoker	3 23.1%	3 21.4%	6 22.2%
Ex-Smoker	2 15.4%	4 28.6%	6 22.2%
Alcohol Classification (Count of Participants)
Yes	1 7.7%	2 14.3%	3 11.1%
No	12 92.3%	12 85.7%	24 88.9%
Duration of Diabetes Mellitus (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.62 (4.471)	6.15 (4.679)	5.89 (4.500)
Glycated hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	7.29 (0.616)	7.19 (0.339)	7.24 (0.485)
Mean Amplitude Glycemic Excursions (MAGE) (millgrams per deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millgrams per deciliter (mg/dL)]	98.02 (44.191)	114.91 (38.454)	106.47 (41.488)
Mean 24-hour Blood Glucose (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	145.65 (17.570)	161.01 (18.349)	153.62 (19.287)
Area Under the Plasma Concentration-time Curve (AUC) of blood glucose (mg*min/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg*min/dL]	41947.9 (5058.50)	46372.7 (5282.47)	44242.3 (5553.22)
Fasting Insulin (uU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [uU/mL]	9.42 (4.177)	8.79 (4.395)	9.09 (4.221)
Fasting Blood Glucose (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	144.0 (17.57)	145.5 (19.15)	144.8 (18.06)

Outcome Measures

1. Primary Outcome

Title	Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
Description	Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
Day(D) 2 Week(W) 3	-7.51	-13.04
D3W3	-11.76	-15.24
D4W3	-11.71	-12.91
D5W3	-9.89	-13.28
D6W3	-12.75	-11.94
D7W3	-9.50	-10.90
D8W3	-7.35	-11.63

2. Secondary Outcome

Title	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
Description	Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3 after breakfast	-90.7	-660.1
D3W3 after breakfast	-241.2	-592.9
D4W3 after breakfast	-632.2	-375.6
D5W3 after breakfast	36.5	-776.3
D6W3 after breakfast	-272.2	-556.5
D7W3 after breakfast	-264.2	-578.2
D8W3 after breakfast	-214.8	-603.6
D2W3 after lunch	-300.3	-626.6
D3W3 after lunch	-383.8	-521.1
D4W3 after lunch	-307.0	-404.1
D5W3 after lunch	-430.4	-589.9
D6W3 after lunch	-353.5	-354.6
D7W3 after lunch	-184.2	-293.6
D8W3 after lunch	-234.0	-546.4
D2W3 after evening meal	-507.6	-375.9
D3W3 after evening meal	-592.4	-484.4
D4W3 after evening meal	-662.4	-597.2
D5W3 after evening meal	-641.9	-427.8
D6W3 after evening meal	-598.8	-552.4
D7W3 after evening meal	-612.6	-374.5
D8W3 after evening meal	-555.4	-346.5

3. Secondary Outcome

Title	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
Description	Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3 after breakfast	-203.7	-1052.7
D3W3 after breakfast	-662.6	-1030.9
D4W3 after breakfast	-1024.6	-958.9
D5W3 after breakfast	-97.2	-1319.8
D6W3 after breakfast	-696.1	-832.5
D7W3 after breakfast	-573.8	-966.3
D8W3 after breakfast	-399.0	-1024.8
D2W3 after lunch	-669.0	-1131.4
D3W3 after lunch	-500.1	-941.9
D4W3 after lunch	-468.2	-701.1
D5W3 after lunch	-793.5	-1065.4
D6W3 after lunch	-798.5	-534.4
D7W3 after lunch	-320.4	-488.7
D8W3 after lunch	-521.3	-923.5
D2W3 after evening meal	-1079.4	-800.5
D3W3 after evening meal	-1273.0	-1023.6
D4W3 after evening meal	-1359.6	-1228.5
D5W3 after evening meal	-1351.4	-756.1
D6W3 after evening meal	-1199.9	-1144.2
D7W3 after evening meal	-884.2	-669.9
D8W3 after evening meal	-1142.0	-577.0

4. Secondary Outcome

Title	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
Description	Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3 after breakfast	-218.5	-981.2
D3W3 after breakfast	-510.2	-926.1
D4W3 after breakfast	-886.4	-801.6
D5W3 after breakfast	-21.3	-1178.0
D6W3 after breakfast	-559.8	-791.8
D7W3 after breakfast	-457.4	-910.1
D8W3 after breakfast	-348.5	-951.6
D2W3 after lunch	-588.5	-1079.1
D3W3 after lunch	-489.7	-845.4
D4W3 after lunch	-429.3	-648.1
D5W3 after lunch	-725.5	-970.0
D6W3 after lunch	-707.9	-517.0
D7W3 after lunch	-294.9	-458.3
D8W3 after lunch	-474.7	-867.4
D2W3 after evening meal	-950.8	-637.6
D3W3 after evening meal	-1077.3	-862.0
D4W3 after evening meal	-1147.1	-1016.8
D5W3 after evening meal	-1147.5	-613.7
D6W3 after evening meal	-1030.6	-966.4
D7W3 after evening meal	-822.3	-586.4
D8W3 after evening meal	-964.8	-535.0

5. Secondary Outcome

Title	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
Description	Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3 after breakfast	-164.5	-829.2
D3W3 after breakfast	-377.8	-770.4
D4W3 after breakfast	-759.4	-609.9
D5W3 after breakfast	25.6	-981.3
D6W3 after breakfast	-405.5	-696.8
D7W3 after breakfast	-356.6	-760.4
D8W3 after breakfast	-273.4	-806.3
D2W3 after lunch	-448.1	-890.4
D3W3 after lunch	-462.2	-705.5
D4W3 after lunch	-389.7	-552.5
D5W3 after lunch	-579.4	-811.9
D6W3 after lunch	-534.1	-469.7
D7W3 after lunch	-249.9	-384.6
D8W3 after lunch	-350.8	-730.1
D2W3 after evening meal	-730.5	-507.4
D3W3 after evening meal	-825.2	-671.1
D4W3 after evening meal	-914.5	-808.9
D5W3 after evening meal	-887.5	-508.3
D6W3 after evening meal	-809.5	-759.6
D7W3 after evening meal	-742.3	-504.1
D8W3 after evening meal	-763.4	-460.2

6. Secondary Outcome

Title	Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Description	Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-1935.9	-4021.4
D3W3	-2001.2	-3378.3
D4W3	-2978.2	-4119.9
D5W3	-2981.5	-4230.4
D6W3	-2550.5	-3840.0
D7W3	-1946.5	-3566.4
D8W3	-2043.5	-3667.1

7. Secondary Outcome

Title	Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Description	Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-1458.0	-3075.8
D3W3	-1702.0	-2767.3
D4W3	-2335.8	-3273.0
D5W3	-2171.8	-3384.5
D6W3	-2031.0	-2990.8
D7W3	-1636.5	-2768.9
D8W3	-1603.9	-2818.8

8. Secondary Outcome

Title	Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Description	Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-989.9	-2247.9
D3W3	-1332.7	-2086.7
D4W3	-1685.1	-2352.2
D5W3	-1486.5	-2492.3
D6W3	-1449.4	-2109.1
D7W3	-1264.2	-1976.3
D8W3	-1166.8	-2009.8

9. Secondary Outcome

Title	Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Description	Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-116.9	-212.5
D3W3	-105.0	-147.1
D4W3	-163.8	-166.1
D5W3	-192.3	-163.2
D6W3	-114.2	-193.2
D7W3	-96.9	-182.1
D8W3	-133.8	-198.6

10. Secondary Outcome

Title	Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Description	Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-134.2	-229.3
D3W3	-75.0	-173.2
D4W3	-167.7	-234.3
D5W3	-200.0	-236.8
D6W3	-153.1	-232.9
D7W3	-93.5	-213.2
D8W3	-115.0	-225.4

11. Secondary Outcome

Title	Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Description	Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-91.2	-210.7
D3W3	-117.3	-167.1
D4W3	-167.3	-236.4
D5W3	-153.1	-225.4
D6W3	-137.7	-216.8
D7W3	-94.2	-194.3
D8W3	-105.0	-193.2

12. Secondary Outcome

Title	Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)
Description	Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-31.2	0.4
D3W3	-43.0	0.0
D4W3	-42.3	13.4
D5W3	-30.5	26.9
D6W3	-39.8	0.0
D7W3	-43.0	0.0
D8W3	-43.0	0.0

13. Secondary Outcome

Title	Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Description	Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3 after breakfast	-11.3	-35.6
D3W3 after breakfast	-35.4	-29.1
D4W3 after breakfast	-39.4	-29.0
D5W3 after breakfast	-4.9	-41.1
D6W3 after breakfast	-28.6	-24.2
D7W3 after breakfast	-23.7	-29.6
D8W3 after breakfast	-16.6	-31.4
D2W3 after lunch	-26.9	-40.8
D3W3 after lunch	-25.9	-35.1
D4W3 after lunch	-21.9	-16.6
D5W3 after lunch	-34.8	-41.6
D6W3 after lunch	-32.7	-18.7
D7W3 after lunch	-11.5	-18.1
D8W3 after lunch	-17.7	-33.6
D2W3 after evening meal	-40.6	-21.3
D3W3 after evening meal	-44.5	-21.6
D4W3 after evening meal	-45.8	-32.7
D5W3 after evening meal	-40.6	-15.6
D6W3 after evening meal	-41.5	-33.8
D7W3 after evening meal	-32.3	-13.9
D8W3 after evening meal	-42.2	-15.9

14. Secondary Outcome

Title	Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal
Description	Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3 between before/after breakfast	-13.9	-28.9
D3W3 between before/after breakfast	-47.4	-35.4
D4W3 between before/after breakfast	-41.2	-42.1
D5W3 between before/after breakfast	-7.0	-25.5
D6W3 between before/after breakfast	-38.6	-29.8
D7W3 between before/after breakfast	-36.4	-33.3
D8W3 between before/after breakfast	-36.2	-34.5
D2W3 between before/after lunch	-30.2	-35.5
D3W3 between before/after lunch	-34.5	-29.5
D4W3 between before/after lunch	-23.8	-6.2
D5W3 between before/after lunch	-34.8	-31.2
D6W3 between before/after lunch	-37.0	-13.1
D7W3 between before/after lunch	-12.7	-14.9
D8W3 between before/after lunch	-15.6	-29.1
D2W3 between before/after evening meal	-37.8	-15.6
D3W3 between before/after evening meal	-49.1	-21.8
D4W3 between before/after evening meal	-42.6	-24.2
D5W3 between before/after evening meal	-31.5	-5.2
D6W3 between before/after evening meal	-41.9	-24.6
D7W3 between before/after evening meal	-33.6	-4.4
D8W3 between before/after evening meal	-39.3	-6.6

15. Secondary Outcome

Title	Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
Description	Change from baseline in MAGE at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-28.42	-47.25
D3W3	-33.72	-52.75
D4W3	-36.08	-44.67
D5W3	-23.12	-50.22
D6W3	-38.05	-34.82
D7W3	-25.74	-37.18
D8W3	-24.26	-41.38

16. Secondary Outcome

Title	Change From Baseline in Mean 24-hour Blood Glucose Levels
Description	Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-8.14	-16.77
D3W3	-8.15	-12.46
D4W3	-13.12	-15.85
D5W3	-13.95	-17.46
D6W3	-8.37	-15.79
D7W3	-6.38	-14.23
D8W3	-8.46	-14.94

17. Secondary Outcome

Title	Change From Baseline in Mean Daytime Blood Glucose Levels
Description	Change from baseline in mean daytime blood glucose levels at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-11.08	-20.38
D3W3	-12.48	-17.21
D4W3	-18.42	-21.80
D5W3	-19.53	-22.54
D6W3	-14.27	-19.34
D7W3	-10.86	-16.92
D8W3	-12.90	-19.78

18. Secondary Outcome

Title	Change From Baseline in Mean Nocturnal Blood Glucose Levels
Description	Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-2.65	-10.69
D3W3	0.52	-3.38
D4W3	-3.17	-3.76
D5W3	-4.09	-6.43
D6W3	5.55	-7.98
D7W3	3.86	-8.59
D8W3	1.06	-5.96

19. Secondary Outcome

Title	Change From Baseline in AUC for Blood Glucose
Description	Change from baseline in AUC for blood glucose levels at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-2340.4	-4828.9
D3W3	-2348.4	-3594.8
D4W3	-3723.2	-4565.6
D5W3	-4017.8	-5023.4
D6W3	-2408.2	-4526.4
D7W3	-1837.6	-4097.5
D8W3	-2438.5	-4302.9

20. Secondary Outcome

Title	Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)
Description	Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-2263.8	-4735.1
D3W3	-2479.2	-3742.8
D4W3	-3755.3	-4576.9
D5W3	-3845.6	-4812.0
D6W3	-2581.9	-4592.1
D7W3	-2184.1	-4169.3
D8W3	-2634.2	-4335.7

21. Secondary Outcome

Title	Standard Deviation (SD) of 24-hour Blood Glucose Values
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
Baseline	38.18	40.44
D2W3	30.68	27.41
D3W3	26.42	25.20
D4W3	26.48	27.54
D5W3	28.29	27.16
D6W3	25.44	28.51
D7W3	28.68	29.54
D8W3	30.84	28.81

22. Secondary Outcome

Title	Changes From Baseline in the SD of Daytime Blood Glucose Values
Description	Change from baseline in SD of daytime blood glucose values at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-9.78	-13.28
D3W3	-12.82	-13.12
D4W3	-11.98	-10.98
D5W3	-10.88	-12.54
D6W3	-11.94	-10.44
D7W3	-8.13	-9.49
D8W3	-6.49	-10.81

23. Secondary Outcome

Title	Changes From Baseline in the SD of Nocturnal Blood Glucose Values
Description	Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.
Time Frame	Baseline, up to 28 days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
D2W3	-0.71	-2.45
D3W3	-3.55	-9.76
D4W3	-4.06	-7.86
D5W3	-2.96	-5.21
D6W3	-5.67	-8.23
D7W3	-5.25	-8.01
D8W3	-2.93	-6.64

24. Secondary Outcome

Title	Number of Participants Reporting One or More Treatment-emergent Adverse Events
Time Frame	Up to 29 days

Outcome Measure Data

Analysis Population Description

Safety Analysis Set (SAS), SAS was defined as participants who received at least one dose of the study drug.

Arm/Group Title	Trelagliptin 100 mg	Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Measure Participants	13	14
Count of Participants [Participants]	1 7.7%	2 14.3%

Adverse Events

Time Frame	Up to 29 days
Adverse Event Reporting Description	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.
Arm/Group Title	Alogliptin 25 mg		Trelagliptin 100 mg
Arm/Group Description	Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.		Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
All Cause Mortality
	Alogliptin 25 mg		Trelagliptin 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)
Serious Adverse Events
	Alogliptin 25 mg		Trelagliptin 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Alogliptin 25 mg		Trelagliptin 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		2/14 (14.3%)
Gastrointestinal disorders
Gastric mucosal lesion	0/13 (0%)		1/14 (7.1%)
General disorders
Feeling abnormal	0/13 (0%)		1/14 (7.1%)
Infections and infestations
Viral upper respiratory tract infection	0/13 (0%)		1/14 (7.1%)
Nervous system disorders
Dizziness	1/13 (7.7%)		0/14 (0%)
Skin and subcutaneous tissue disorders
Eczema	0/13 (0%)		1/14 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.