Trial Outcomes & Findings for Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus (NCT NCT03231709)
NCT ID: NCT03231709
Last Updated: 2023-12-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
At Week 16
Results posted on
2023-12-22
Participant Flow
Participants took part in the study at 2 investigative sites in Japan from 18 August 2017 to 4 February 2018.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
30
|
30
|
|
Treatment Period 1
COMPLETED
|
30
|
29
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2
STARTED
|
30
|
29
|
|
Treatment Period 2
COMPLETED
|
30
|
28
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Treatment Period 1
Reason not Specified
|
0
|
1
|
|
Treatment Period 2
Pretreatment Event/Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trelagliptin 100 mg + Alogliptin 25 mg
n=30 Participants
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 25 mg + Trelagliptin 100 mg
n=30 Participants
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
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 8.86 • n=30 Participants
|
59.7 years
STANDARD_DEVIATION 8.73 • n=30 Participants
|
60.1 years
STANDARD_DEVIATION 8.73 • n=60 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=30 Participants
|
28 Participants
n=30 Participants
|
54 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Height
|
169.2 cm
STANDARD_DEVIATION 7.44 • n=30 Participants
|
169.9 cm
STANDARD_DEVIATION 6.58 • n=30 Participants
|
169.5 cm
STANDARD_DEVIATION 6.97 • n=60 Participants
|
|
Weight
|
70.57 kg
STANDARD_DEVIATION 10.79 • n=30 Participants
|
69.87 kg
STANDARD_DEVIATION 10.79 • n=30 Participants
|
70.22 kg
STANDARD_DEVIATION 10.70 • n=60 Participants
|
|
Body Mass Index (BMI)
|
24.61 kg/m^2
STANDARD_DEVIATION 3.22 • n=30 Participants
|
24.19 kg/m^2
STANDARD_DEVIATION 3.31 • n=30 Participants
|
24.40 kg/m^2
STANDARD_DEVIATION 3.24 • n=60 Participants
|
|
Smoking Habits
Had Smoking Habits
|
3 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
10 Participants
n=60 Participants
|
|
Smoking Habits
Had No Smoking Habits
|
27 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
50 Participants
n=60 Participants
|
|
Alcohol intake history
Regular Drinker
|
19 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
35 Participants
n=60 Participants
|
|
Alcohol intake history
Occasional Drinker
|
1 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
|
Alcohol intake history
Non-Drinker
|
10 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Duration of diabetes mellitus
3 Years or More
|
26 Participants
n=30 Participants
|
29 Participants
n=30 Participants
|
55 Participants
n=60 Participants
|
|
Duration of diabetes mellitus
Less than 3 Years
|
4 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP)
|
7.34 percent
STANDARD_DEVIATION 0.63 • n=30 Participants
|
7.41 percent
STANDARD_DEVIATION 0.84 • n=30 Participants
|
7.38 percent
STANDARD_DEVIATION 0.74 • n=60 Participants
|
|
Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent
|
23.7 score on a scale
STANDARD_DEVIATION 5.86 • n=30 Participants
|
23.0 score on a scale
STANDARD_DEVIATION 5.48 • n=30 Participants
|
23.3 score on a scale
STANDARD_DEVIATION 5.64 • n=60 Participants
|
|
Work status
Worker
|
24 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
47 Participants
n=60 Participants
|
|
Work status
Unemployed
|
6 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
13 Participants
n=60 Participants
|
|
Presence of Cohabiter
Living alone
|
4 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
|
Presence of Cohabiter
Living together
|
26 Participants
n=30 Participants
|
26 Participants
n=30 Participants
|
52 Participants
n=60 Participants
|
|
Experience in Educational Hospitalization on Diabetes
Had Experience
|
3 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
|
Experience in Educational Hospitalization on Diabetes
Had No Experience
|
27 Participants
n=30 Participants
|
28 Participants
n=30 Participants
|
55 Participants
n=60 Participants
|
|
Compliance With DPP-4 Inhibitors During 4-Week Before Start of Treatment
90 Percent or More
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Number of Oral Drugs/Day at the Start of the Treatment Period, Excluding Study Drug
1 or 2 Tablet(s)
|
12 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
21 Participants
n=60 Participants
|
|
Number of Oral Drugs/Day at the Start of the Treatment Period, Excluding Study Drug
3 - 5 Tablets
|
13 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
|
Number of Oral Drugs/Day at the Start of the Treatment Period, Excluding Study Drug
6 Tablets or More
|
5 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
|
Complication of Metabolic Syndrome
Had Presence of Complications
|
11 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
22 Participants
n=60 Participants
|
|
Complication of Metabolic Syndrome
Had No Presence of Complications
|
19 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
38 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg + Alogliptin 25 mg
n=30 Participants
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 25 mg + Trelagliptin 100 mg
n=30 Participants
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.
|
Alogliptin Preference
Participants who prefer alogliptin 25 mg, tablets, once a day.
|
Neither Trelagliptin Nor Alogliptin
Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
|
|---|---|---|---|---|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period
Neither Trelagliptin nor Alogliptin
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period
Alogliptin
|
18 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period
Either Trelagliptin or Alogliptin
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period
Trelagliptin
|
8 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg + Alogliptin 25 mg
n=11 Participants
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 25 mg + Trelagliptin 100 mg
n=18 Participants
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.
|
Alogliptin Preference
n=31 Participants
Participants who prefer alogliptin 25 mg, tablets, once a day.
|
Neither Trelagliptin Nor Alogliptin
Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
|
|---|---|---|---|---|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
HbA1c (NGSP), 7.0%<= - <8.0%
|
7 Participants
|
8 Participants
|
14 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
HbA1c (NGSP), 8.0%<=
|
3 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
HbA1c (NGSP), < 7.0%
|
1 Participants
|
6 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Age, Min <= - <65
|
9 Participants
|
13 Participants
|
16 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Age, 65 <= - <75
|
2 Participants
|
5 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Gender, Male
|
11 Participants
|
16 Participants
|
27 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Gender, Female
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Height, Min <= - <150
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Height, 150 <= - <160
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Height, 160 <= - <170
|
1 Participants
|
9 Participants
|
14 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Height, 170 <= - <=Max
|
10 Participants
|
7 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Weight, Min <= - <50.0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Weight, 50.0 <= - <60.0
|
0 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Weight, 60.0<= - <70.0
|
3 Participants
|
3 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Weight, 70.0 <= - <80.0
|
8 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Weight, 80.0 <= - <=Max
|
0 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
BMI, Min <= - <18.5
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
BMI, 18.5 <= - <25.0
|
9 Participants
|
9 Participants
|
18 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
BMI, 25.0 <= - <=Max
|
2 Participants
|
8 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Duration of Diabetes, 3 Years or More
|
10 Participants
|
17 Participants
|
28 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Duration of Diabetes, Less than 3 Years
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Work Status, Worker
|
9 Participants
|
16 Participants
|
22 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Work Status, Unemployed
|
2 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Alcohol Intake History, Regular Drinker
|
5 Participants
|
7 Participants
|
23 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Alcohol Intake History, Occasional Drinker
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Alcohol Intake History, Non-Drinker
|
4 Participants
|
8 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Had Smoking Habits
|
4 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Had No Smoking Habits
|
7 Participants
|
14 Participants
|
29 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Had Experience of Educational Hospitalization
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Had No Experience of Educational Hospitalization
|
8 Participants
|
18 Participants
|
29 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Presence of Cohabiter, Live alone
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Presence of Cohabiter, Living together
|
10 Participants
|
15 Participants
|
27 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Compliance with DPP-4 Inhibitors, 90% or More
|
11 Participants
|
18 Participants
|
31 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Number of Oral Drugs per Day, 1 or 2 Tablet(s)
|
1 Participants
|
7 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Number of Oral Drugs per Day, 3 - 5 Tablets
|
5 Participants
|
8 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Number of Oral Drugs per Day, 6 Tablets or More
|
5 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Had Complication of Metabolic Syndrome
|
4 Participants
|
4 Participants
|
14 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
Had No Complication of Metabolic Syndrome
|
7 Participants
|
14 Participants
|
17 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg + Alogliptin 25 mg
n=4 Participants
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 25 mg + Trelagliptin 100 mg
n=8 Participants
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.
|
Alogliptin Preference
n=18 Participants
Participants who prefer alogliptin 25 mg, tablets, once a day.
|
Neither Trelagliptin Nor Alogliptin
Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
|
|---|---|---|---|---|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Had Complication of Metabolic Syndrome
|
1 Participants
|
1 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
HbA1c (NGSP), 8.0%<=
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Age, Min <= - <65
|
4 Participants
|
5 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Age, 65 <= - <75
|
0 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Gender, Male
|
4 Participants
|
7 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Gender, Female
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Height, Min <= - <150
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Height, 150 <= - <160
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Height, 160 <= - <170
|
0 Participants
|
3 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Height, 170 <= - <=Max
|
4 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Weight, Min <= - <50.0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Weight, 50.0 <= - <60.0
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Weight, 60.0<= - <70.0
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Weight, 70.0 <= - <80.0
|
3 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Weight, 80.0 <= - <=Max
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
BMI, 18.5 <= - <25.0
|
4 Participants
|
4 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
BMI, 25.0 <= - <=Max
|
0 Participants
|
4 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Duration of Diabetes, 3 Years or More
|
4 Participants
|
7 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Duration of Diabetes, Less than 3 Years
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Work Status, Worker
|
4 Participants
|
7 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Work Status, Unemployed
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Alcohol Intake History, Regular Drinker
|
3 Participants
|
4 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Alcohol Intake History, Occasional Drinker
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Alcohol Intake History, Non-Drinker
|
0 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Had Smoking Habits
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Had No Smoking Habits
|
4 Participants
|
6 Participants
|
17 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Had Experience of Educational Hospitalization
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Had No Experience of Educational Hospitalization
|
2 Participants
|
8 Participants
|
17 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Presence of Cohabiter, Live alone
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Presence of Cohabiter, Living together
|
4 Participants
|
6 Participants
|
16 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Compliance with DPP-4 Inhibitors, 90% or More
|
4 Participants
|
8 Participants
|
18 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Number of Oral Drugs per Day, 1 or 2 Tablet(s)
|
1 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Number of Oral Drugs per Day, 3 - 5 Tablets
|
3 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Number of Oral Drugs per Day, 6 Tablets or More
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
Had No Complication of Metabolic Syndrome
|
3 Participants
|
7 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
HbA1c (NGSP), < 7.0%
|
1 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
HbA1c (NGSP), 7.0%<= - <8.0%
|
1 Participants
|
4 Participants
|
11 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.
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.
Outcome measures
| Measure |
Trelagliptin 100 mg + Alogliptin 25 mg
n=7 Participants
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 25 mg + Trelagliptin 100 mg
n=10 Participants
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.
|
Alogliptin Preference
n=13 Participants
Participants who prefer alogliptin 25 mg, tablets, once a day.
|
Neither Trelagliptin Nor Alogliptin
Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day.
|
|---|---|---|---|---|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Had Smoking Habits
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Age, Min <= - <65
|
5 Participants
|
8 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Age, 65 <= - <75
|
2 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Gender, Male
|
7 Participants
|
9 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Gender, Female
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Height, 150 <= - <160
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Height, 160 <= - <170
|
1 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Height, 170 <= - <=Max
|
6 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Weight, 50.0 <= - <60.0
|
0 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Weight, 60.0<= - <70.0
|
2 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Weight, 70.0 <= - <80.0
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Weight, 80.0 <= - <=Max
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
BMI, Min <= - <18.5
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
BMI, 18.5 <= - <25.0
|
5 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
BMI, 25.0 <= - <=Max
|
2 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Duration of Diabetes, 3 Years or More
|
6 Participants
|
10 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Duration of Diabetes, Less than 3 Years
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Work Status, Worker
|
5 Participants
|
9 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Work Status, Unemployed
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Alcohol Intake History, Regular Drinker
|
2 Participants
|
3 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Alcohol Intake History, Occasional Drinker
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Alcohol Intake History, Non-Drinker
|
4 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Had No Smoking Habits
|
3 Participants
|
8 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Had Experience of Educational Hospitalization
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Had No Experience of Educational Hospitalization
|
6 Participants
|
10 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Presence of Cohabiter, Live alone
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Presence of Cohabiter, Living together
|
6 Participants
|
9 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Compliance with DPP-4 Inhibitors, 90% or More
|
7 Participants
|
10 Participants
|
13 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Number of Oral Drugs per Day, 1 or 2 Tablet(s)
|
0 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Number of Oral Drugs per Day, 3 - 5 Tablets
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Number of Oral Drugs per Day, 6 Tablets or More
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Had Complication of Metabolic Syndrome
|
3 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
Had No Complication of Metabolic Syndrome
|
4 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
HbA1c (NGSP), < 7.0%
|
0 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
HbA1c (NGSP), 7.0%<= - <8.0%
|
6 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
HbA1c (NGSP), 8.0%<=
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Trelagliptin 100 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Alogliptin 25 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trelagliptin 100 mg
n=59 participants at risk
Trelagliptin 100 mg tablets, orally, once a week for 8 weeks in either Period 1 or 2.
|
Alogliptin 25 mg
n=60 participants at risk
Alogliptin 25 mg tablets, orally, once a day for 8 weeks in either Period 1 or 2.
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
1/59 • Up to Week 16
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Week 16
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.7%
1/59 • Up to Week 16
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Week 16
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.
|
Other adverse events
| Measure |
Trelagliptin 100 mg
n=59 participants at risk
Trelagliptin 100 mg tablets, orally, once a week for 8 weeks in either Period 1 or 2.
|
Alogliptin 25 mg
n=60 participants at risk
Alogliptin 25 mg tablets, orally, once a day for 8 weeks in either Period 1 or 2.
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.4%
2/59 • Up to Week 16
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.
|
1.7%
1/60 • Up to Week 16
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
2/59 • Up to Week 16
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Week 16
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Medical Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER