TRINITY: Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03231709
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Actual Duration (Months): 5.7
• Patients Per Site: 30
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the participant's preference for treatment with once-weekly dosing of DPP-4 inhibitor trelagliptin versus once-daily dosing of DPP-4 inhibitor alogliptin among the participants with type 2 diabetes mellitus who are being treated with once-daily dosing of DPP-4 inhibitor.

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

Detailed Description

The drugs being tested in this study are called Trelagliptin and Alogliptin. This study will look at the participant's preference for treatment with Trelagliptin versus Alogliptin.

The study enrolled 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

• Trelagliptin 100 mg, followed by Alogliptin 25 mg

• Alogliptin 25 mg, followed by Trelagliptin 100 mg All participants will be asked to take one tablet of trelagliptin orally once a week or one tablet of alogliptin orally once a day throughout the study period.

This multi-center trial will be conducted in Japan. The overall time to participate in this study is 16 weeks. Participants will make 3 visits to the clinic.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment Preference for Weekly DPP-4 Inhibitors Versus Daily DPP-4 Inhibitors in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Aug 18, 2017
• Actual Primary Completion Date: Feb 9, 2018
• Actual Study Completion Date: Feb 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trelagliptin 100 mg + Alogliptin 25 mg Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.	Drug: Trelagliptin; Trelagliptin tablets; Drug: Alogliptin; Alogliptin tablets
Experimental: Alogliptin 25 mg + Trelagliptin 100 mg Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.	Drug: Trelagliptin; Trelagliptin tablets; Drug: Alogliptin; Alogliptin tablets

Outcome Measures

Primary Outcome Measures

1. Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period [At Week 16]

   Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. Participants selected one choice from the following 4 choices; either once-weekly DPP-4 inhibitor or daily DPP-4 inhibitor, once-weekly DPP-4 inhibitor, daily DPP-4 inhibitor, neither once-weekly DPP-4 inhibitor nor daily DPP-4 inhibitor. Reported data was the number of participants with a choice of either trelagliptin (once-weekly DPP-4 inhibitor) or alogliptin (once-daily DPP-4 inhibitor), trelagliptin, alogliptin, neither trelagliptin nor alogliptin.

Secondary Outcome Measures

1. Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors [At Week 16]

   Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.

2. Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group) [At Week 16]

   Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.

3. Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group) [At Week 16]

   Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.

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 have been diagnosed with type 2 diabetes mellitus.

2. Participants who are being treated with any of the following DPP-4 inhibitors for at least 8 weeks prior to the time of informed consent (Week 0).

• Sitagliptin : 50 mg once daily

• Alogliptin : 25 mg once daily

• Linagliptin : 5 mg once daily

• Teneligliptin : 20 mg once daily

• Saxagliptin : 5 mg once daily

1. Participants who were judged by the investigators possible to change the treatment from daily dosing of DPP-4 inhibitor shown in Inclusion Criteria 2 to study drug trelagliptin 100 mg or alogliptin 25 mg.

2. Participants whose glycosylated hemoglobin (HbA1c) value measured within 8 weeks prior to the time of informed consent (Week 0) is below 10.0%.

3. Participants who responded to Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent (Week 0).

4. Participants who were judged by the investigators capable to understand the contents of this clinical research and comply with them.

5. Participants who are able to sign and date the Informed Consent Form before any clinical research procedure begins.

6. Participants who are at least 20 years old at the time of giving the consent.

7. Participants who are classified as outpatients.

Exclusion Criteria:

1. Participants who have a history of taking once-weekly dosing of DPP-4 inhibitor (trelagliptin or omarigliptin).

2. Participants who are being treated with drugs other than those for once-daily oral dosing for the purpose of treatment of chronic complication (for example, "BENET® Tablets 75 mg", a therapeutic agent for osteoporosis which is administered once monthly).

3. Participants who are being treated with twice-daily dosing of DPP-4 inhibitor (vildagliptin or anagliptin).

4. Participants who are being treated with anti-diabetic fixed-dose combination pill contained a DPP-4 inhibitor.

5. Participants with moderate or severe renal impairment (for example, participant whose estimated glomerular filtration rate (eGFR) is below 60 mL/min/1.73m^2).

6. Participants for whom blood sugar control by insulin preparations is desired (for example, participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, or serious trauma before or after surgery).

7. Participants who have a history of hypersensitivity or allergy to DPP-4 inhibitor.

8. Participants with serious heart disease, cerebrovascular disorder, or participants with serious disease in the pancreas, blood, etc.

9. Participants with unstable proliferative diabetic retinopathy.

10. Participants with malignant tumor.

11. Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.

12. Participants participating in other clinical studies.

13. Participants who have been determined as inappropriate participants by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OCROM Clinic	Suita	Osaka	Japan
2	ToCROM Clinic	Shinjuku	Tokyo	Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

• Study Protocol - Jun 6, 2017
• Statistical Analysis Plan - Mar 15, 2018

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT03231709
• Other Study ID Numbers: Trelagliptin-4003; U1111-1197-5821; JapicCTI-173662
• First Posted: Jul 27, 2017
• Last Update Posted: May 10, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• 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 18 August 2017 to 4 February 2018.
Pre-assignment Detail	Participants with a diagnosis of Type 2 Diabetes Mellitus (DM) were enrolled in 1 of 2 crossover arms: trelagliptin 100 mg then alogliptin 25 mg or alogliptin 25 mg then trelagliptin 100 mg.

Arm/Group Title	Trelagliptin 100 mg + Alogliptin 25 mg	Alogliptin 25 mg + Trelagliptin 100 mg
Arm/Group Description	Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.	Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.
Period Title: Treatment Period 1
STARTED	30	30
COMPLETED	30	29
NOT COMPLETED	0	1
Period Title: Treatment Period 1
STARTED	30	29
COMPLETED	30	28
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Trelagliptin 100 mg + Alogliptin 25 mg	Alogliptin 25 mg + Trelagliptin 100 mg	Total
Arm/Group Description	Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.	Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (8.86)	59.7 (8.73)	60.1 (8.73)
Sex: Female, Male (Count of Participants)
Female	4 13.3%	2 6.7%	6 10%
Male	26 86.7%	28 93.3%	54 90%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Japan	30 100%	30 100%	60 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	169.2 (7.44)	169.9 (6.58)	169.5 (6.97)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	70.57 (10.79)	69.87 (10.79)	70.22 (10.70)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	24.61 (3.22)	24.19 (3.31)	24.40 (3.24)
Smoking Habits (Count of Participants)
Had Smoking Habits	3 10%	7 23.3%	10 16.7%
Had No Smoking Habits	27 90%	23 76.7%	50 83.3%
Alcohol intake history (Count of Participants)
Regular Drinker	19 63.3%	16 53.3%	35 58.3%
Occasional Drinker	1 3.3%	4 13.3%	5 8.3%
Non-Drinker	10 33.3%	10 33.3%	20 33.3%
Duration of diabetes mellitus (Count of Participants)
3 Years or More	26 86.7%	29 96.7%	55 91.7%
Less than 3 Years	4 13.3%	1 3.3%	5 8.3%
Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	7.34 (0.63)	7.41 (0.84)	7.38 (0.74)
Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	23.7 (5.86)	23.0 (5.48)	23.3 (5.64)
Work status (Count of Participants)
Worker	24 80%	23 76.7%	47 78.3%
Unemployed	6 20%	7 23.3%	13 21.7%
Presence of Cohabiter (Count of Participants)
Living alone	4 13.3%	4 13.3%	8 13.3%
Living together	26 86.7%	26 86.7%	52 86.7%
Experience in Educational Hospitalization on Diabetes (Count of Participants)
Had Experience	3 10%	2 6.7%	5 8.3%
Had No Experience	27 90%	28 93.3%	55 91.7%
Compliance With DPP-4 Inhibitors During 4-Week Before Start of Treatment (Count of Participants)
90 Percent or More	30 100%	30 100%	60 100%
Number of Oral Drugs/Day at the Start of the Treatment Period, Excluding Study Drug (Count of Participants)
1 or 2 Tablet(s)	12 40%	9 30%	21 35%
3 - 5 Tablets	13 43.3%	11 36.7%	24 40%
6 Tablets or More	5 16.7%	10 33.3%	15 25%
Complication of Metabolic Syndrome (Count of Participants)
Had Presence of Complications	11 36.7%	11 36.7%	22 36.7%
Had No Presence of Complications	19 63.3%	19 63.3%	38 63.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period
Description	Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. Participants selected one choice from the following 4 choices; either once-weekly DPP-4 inhibitor or daily DPP-4 inhibitor, once-weekly DPP-4 inhibitor, daily DPP-4 inhibitor, neither once-weekly DPP-4 inhibitor nor daily DPP-4 inhibitor. Reported data was the number of participants with a choice of either trelagliptin (once-weekly DPP-4 inhibitor) or alogliptin (once-daily DPP-4 inhibitor), trelagliptin, alogliptin, neither trelagliptin nor alogliptin.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.

Arm/Group Title	Trelagliptin 100 mg + Alogliptin 25 mg	Alogliptin 25 mg + Trelagliptin 100 mg
Arm/Group Description	Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.	Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.
Measure Participants	30	30
Either Trelagliptin or Alogliptin	4 13.3%	7 23.3%
Trelagliptin	8 26.7%	10 33.3%
Alogliptin	18 60%	13 43.3%
Neither Trelagliptin nor Alogliptin	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trelagliptin 100 mg + Alogliptin 25 mg, Alogliptin 25 mg + Trelagliptin 100 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0141
	Comments
	Method	Mainland-Gart Test
	Comments

2. Secondary Outcome

Title	Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Description	Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.

Arm/Group Title	Either Trelagliptin or Alogliptin	Trelagliptin Preference	Alogliptin Preference	Neither Trelagliptin Nor Alogliptin
Arm/Group Description	Participants who prefer either trelagliptin 100 mg, tablets, once a week or alogliptin 25 mg, tablets once a day.	Participants who prefer trelagliptin 100 mg, tablets, once a week.	Participants who prefer alogliptin 25 mg, tablets, once a day.	Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
Measure Participants	11	18	31	0
Age, Min <= - <65	9 30%	13 43.3%	16 26.7%	0 NaN
Age, 65 <= - <75	2 6.7%	5 16.7%	15 25%	0 NaN
Gender, Male	11 36.7%	16 53.3%	27 45%	0 NaN
Gender, Female	0 0%	2 6.7%	4 6.7%	0 NaN
Height, Min <= - <150	0 0%	1 3.3%	0 0%	0 NaN
Height, 150 <= - <160	0 0%	1 3.3%	2 3.3%	0 NaN
Height, 160 <= - <170	1 3.3%	9 30%	14 23.3%	0 NaN
Height, 170 <= - <=Max	10 33.3%	7 23.3%	15 25%	0 NaN
Weight, Min <= - <50.0	0 0%	1 3.3%	0 0%	0 NaN
Weight, 50.0 <= - <60.0	0 0%	5 16.7%	5 8.3%	0 NaN
Weight, 60.0<= - <70.0	3 10%	3 10%	12 20%	0 NaN
Weight, 70.0 <= - <80.0	8 26.7%	6 20%	7 11.7%	0 NaN
Weight, 80.0 <= - <=Max	0 0%	3 10%	7 11.7%	0 NaN
BMI, Min <= - <18.5	0 0%	1 3.3%	0 0%	0 NaN
BMI, 18.5 <= - <25.0	9 30%	9 30%	18 30%	0 NaN
BMI, 25.0 <= - <=Max	2 6.7%	8 26.7%	13 21.7%	0 NaN
Duration of Diabetes, 3 Years or More	10 33.3%	17 56.7%	28 46.7%	0 NaN
Duration of Diabetes, Less than 3 Years	1 3.3%	1 3.3%	3 5%	0 NaN
Work Status, Worker	9 30%	16 53.3%	22 36.7%	0 NaN
Work Status, Unemployed	2 6.7%	2 6.7%	9 15%	0 NaN
Alcohol Intake History, Regular Drinker	5 16.7%	7 23.3%	23 38.3%	0 NaN
Alcohol Intake History, Occasional Drinker	2 6.7%	3 10%	0 0%	0 NaN
Alcohol Intake History, Non-Drinker	4 13.3%	8 26.7%	8 13.3%	0 NaN
Had Smoking Habits	4 13.3%	4 13.3%	2 3.3%	0 NaN
Had No Smoking Habits	7 23.3%	14 46.7%	29 48.3%	0 NaN
Had Experience of Educational Hospitalization	3 10%	0 0%	2 3.3%	0 NaN
Had No Experience of Educational Hospitalization	8 26.7%	18 60%	29 48.3%	0 NaN
Presence of Cohabiter, Live alone	1 3.3%	3 10%	4 6.7%	0 NaN
Presence of Cohabiter, Living together	10 33.3%	15 50%	27 45%	0 NaN
Compliance with DPP-4 Inhibitors, 90% or More	11 36.7%	18 60%	31 51.7%	0 NaN
Number of Oral Drugs per Day, 1 or 2 Tablet(s)	1 3.3%	7 23.3%	13 21.7%	0 NaN
Number of Oral Drugs per Day, 3 - 5 Tablets	5 16.7%	8 26.7%	11 18.3%	0 NaN
Number of Oral Drugs per Day, 6 Tablets or More	5 16.7%	3 10%	7 11.7%	0 NaN
Had Complication of Metabolic Syndrome	4 13.3%	4 13.3%	14 23.3%	0 NaN
Had No Complication of Metabolic Syndrome	7 23.3%	14 46.7%	17 28.3%	0 NaN
HbA1c (NGSP), < 7.0%	1 3.3%	6 20%	11 18.3%	0 NaN
HbA1c (NGSP), 7.0%<= - <8.0%	7 23.3%	8 26.7%	14 23.3%	0 NaN
HbA1c (NGSP), 8.0%<=	3 10%	4 13.3%	6 10%	0 NaN

3. Secondary Outcome

Title	Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Description	Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.

Arm/Group Title	Either Trelagliptin or Alogliptin	Trelagliptin Preference	Alogliptin Preference	Neither Trelagliptin Nor Alogliptin
Arm/Group Description	Participants who prefer either trelagliptin 100 mg, tablets, once a week or alogliptin 25 mg, tablets once a day.	Participants who prefer trelagliptin 100 mg, tablets, once a week.	Participants who prefer alogliptin 25 mg, tablets, once a day.	Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
Measure Participants	4	8	18	0
Age, Min <= - <65	4 13.3%	5 16.7%	9 15%	0 NaN
Age, 65 <= - <75	0 0%	3 10%	9 15%	0 NaN
Gender, Male	4 13.3%	7 23.3%	15 25%	0 NaN
Gender, Female	0 0%	1 3.3%	3 5%	0 NaN
Height, Min <= - <150	0 0%	1 3.3%	0 0%	0 NaN
Height, 150 <= - <160	0 0%	0 0%	1 1.7%	0 NaN
Height, 160 <= - <170	0 0%	3 10%	11 18.3%	0 NaN
Height, 170 <= - <=Max	4 13.3%	4 13.3%	6 10%	0 NaN
Weight, Min <= - <50.0	0 0%	1 3.3%	0 0%	0 NaN
Weight, 50.0 <= - <60.0	0 0%	0 0%	4 6.7%	0 NaN
Weight, 60.0<= - <70.0	1 3.3%	2 6.7%	5 8.3%	0 NaN
Weight, 70.0 <= - <80.0	3 10%	4 13.3%	5 8.3%	0 NaN
Weight, 80.0 <= - <=Max	0 0%	1 3.3%	4 6.7%	0 NaN
BMI, 18.5 <= - <25.0	4 13.3%	4 13.3%	10 16.7%	0 NaN
BMI, 25.0 <= - <=Max	0 0%	4 13.3%	8 13.3%	0 NaN
Duration of Diabetes, 3 Years or More	4 13.3%	7 23.3%	15 25%	0 NaN
Duration of Diabetes, Less than 3 Years	0 0%	1 3.3%	3 5%	0 NaN
Work Status, Worker	4 13.3%	7 23.3%	13 21.7%	0 NaN
Work Status, Unemployed	0 0%	1 3.3%	5 8.3%	0 NaN
Alcohol Intake History, Regular Drinker	3 10%	4 13.3%	12 20%	0 NaN
Alcohol Intake History, Occasional Drinker	1 3.3%	0 0%	0 0%	0 NaN
Alcohol Intake History, Non-Drinker	0 0%	4 13.3%	6 10%	0 NaN
Had Smoking Habits	0 0%	2 6.7%	1 1.7%	0 NaN
Had No Smoking Habits	4 13.3%	6 20%	17 28.3%	0 NaN
Had Experience of Educational Hospitalization	2 6.7%	0 0%	1 1.7%	0 NaN
Had No Experience of Educational Hospitalization	2 6.7%	8 26.7%	17 28.3%	0 NaN
Presence of Cohabiter, Live alone	0 0%	2 6.7%	2 3.3%	0 NaN
Presence of Cohabiter, Living together	4 13.3%	6 20%	16 26.7%	0 NaN
Compliance with DPP-4 Inhibitors, 90% or More	4 13.3%	8 26.7%	18 30%	0 NaN
Number of Oral Drugs per Day, 1 or 2 Tablet(s)	1 3.3%	2 6.7%	9 15%	0 NaN
Number of Oral Drugs per Day, 3 - 5 Tablets	3 10%	5 16.7%	5 8.3%	0 NaN
Number of Oral Drugs per Day, 6 Tablets or More	0 0%	1 3.3%	4 6.7%	0 NaN
Had Complication of Metabolic Syndrome	1 3.3%	1 3.3%	9 15%	0 NaN
Had No Complication of Metabolic Syndrome	3 10%	7 23.3%	9 15%	0 NaN
HbA1c (NGSP), < 7.0%	1 3.3%	4 13.3%	3 5%	0 NaN
HbA1c (NGSP), 7.0%<= - <8.0%	1 3.3%	4 13.3%	11 18.3%	0 NaN
HbA1c (NGSP), 8.0%<=	2 6.7%	0 0%	4 6.7%	0 NaN

4. Secondary Outcome

Title	Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Description	Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.
Time Frame	At Week 16

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.

Arm/Group Title	Either Trelagliptin or Alogliptin	Trelagliptin Preference	Alogliptin Preference	Neither Trelagliptin Nor Alogliptin
Arm/Group Description	Participants who prefer either trelagliptin 100 mg, tablets, once a week or alogliptin 25 mg, tablets once a day.	Participants who prefer trelagliptin 100 mg, tablets, once a week.	Participants who prefer alogliptin 25 mg, tablets, once a day.	Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
Measure Participants	7	10	13	0
Age, Min <= - <65	5 16.7%	8 26.7%	7 11.7%	0 NaN
Age, 65 <= - <75	2 6.7%	2 6.7%	6 10%	0 NaN
Gender, Male	7 23.3%	9 30%	12 20%	0 NaN
Gender, Female	0 0%	1 3.3%	1 1.7%	0 NaN
Height, 150 <= - <160	0 0%	1 3.3%	1 1.7%	0 NaN
Height, 160 <= - <170	1 3.3%	6 20%	3 5%	0 NaN
Height, 170 <= - <=Max	6 20%	3 10%	9 15%	0 NaN
Weight, 50.0 <= - <60.0	0 0%	5 16.7%	1 1.7%	0 NaN
Weight, 60.0<= - <70.0	2 6.7%	1 3.3%	7 11.7%	0 NaN
Weight, 70.0 <= - <80.0	5 16.7%	2 6.7%	2 3.3%	0 NaN
Weight, 80.0 <= - <=Max	0 0%	2 6.7%	3 5%	0 NaN
BMI, Min <= - <18.5	0 0%	1 3.3%	0 0%	0 NaN
BMI, 18.5 <= - <25.0	5 16.7%	5 16.7%	8 13.3%	0 NaN
BMI, 25.0 <= - <=Max	2 6.7%	4 13.3%	5 8.3%	0 NaN
Duration of Diabetes, 3 Years or More	6 20%	10 33.3%	13 21.7%	0 NaN
Duration of Diabetes, Less than 3 Years	1 3.3%	0 0%	0 0%	0 NaN
Work Status, Worker	5 16.7%	9 30%	9 15%	0 NaN
Work Status, Unemployed	2 6.7%	1 3.3%	4 6.7%	0 NaN
Alcohol Intake History, Regular Drinker	2 6.7%	3 10%	11 18.3%	0 NaN
Alcohol Intake History, Occasional Drinker	1 3.3%	3 10%	0 0%	0 NaN
Alcohol Intake History, Non-Drinker	4 13.3%	4 13.3%	2 3.3%	0 NaN
Had Smoking Habits	4 13.3%	2 6.7%	1 1.7%	0 NaN
Had No Smoking Habits	3 10%	8 26.7%	12 20%	0 NaN
Had Experience of Educational Hospitalization	1 3.3%	0 0%	1 1.7%	0 NaN
Had No Experience of Educational Hospitalization	6 20%	10 33.3%	12 20%	0 NaN
Presence of Cohabiter, Live alone	1 3.3%	1 3.3%	2 3.3%	0 NaN
Presence of Cohabiter, Living together	6 20%	9 30%	11 18.3%	0 NaN
Compliance with DPP-4 Inhibitors, 90% or More	7 23.3%	10 33.3%	13 21.7%	0 NaN
Number of Oral Drugs per Day, 1 or 2 Tablet(s)	0 0%	5 16.7%	4 6.7%	0 NaN
Number of Oral Drugs per Day, 3 - 5 Tablets	2 6.7%	3 10%	6 10%	0 NaN
Number of Oral Drugs per Day, 6 Tablets or More	5 16.7%	2 6.7%	3 5%	0 NaN
Had Complication of Metabolic Syndrome	3 10%	3 10%	5 8.3%	0 NaN
Had No Complication of Metabolic Syndrome	4 13.3%	7 23.3%	8 13.3%	0 NaN
HbA1c (NGSP), < 7.0%	0 0%	2 6.7%	8 13.3%	0 NaN
HbA1c (NGSP), 7.0%<= - <8.0%	6 20%	4 13.3%	3 5%	0 NaN
HbA1c (NGSP), 8.0%<=	1 3.3%	4 13.3%	2 3.3%	0 NaN

Adverse Events

Time Frame	Up to Week 16
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	Trelagliptin 100 mg		Alogliptin 25 mg
Arm/Group Description	Trelagliptin 100 mg tablets, orally, once a week for 8 weeks in either Period 1 or 2.		Alogliptin 25 mg tablets, orally, once a day for 8 weeks in either Period 1 or 2.
All Cause Mortality
	Trelagliptin 100 mg		Alogliptin 25 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/60 (0%)
Serious Adverse Events
	Trelagliptin 100 mg		Alogliptin 25 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/59 (1.7%)		0/60 (0%)
Gastrointestinal disorders
Intestinal obstruction	1/59 (1.7%)		0/60 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/59 (1.7%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Trelagliptin 100 mg		Alogliptin 25 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/59 (6.8%)		1/60 (1.7%)
Infections and infestations
Viral upper respiratory tract infection	2/59 (3.4%)		1/60 (1.7%)
Upper respiratory tract infection	2/59 (3.4%)		0/60 (0%)

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.