Back to resultsTreatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus (TRINITY)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Trelagliptin
Alogliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Participants who have been diagnosed with type 2 diabetes mellitus.
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
- 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.
- Participants whose glycosylated hemoglobin (HbA1c) value measured within 8 weeks prior to the time of informed consent (Week 0) is below 10.0%.
- Participants who responded to Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent (Week 0).
- Participants who were judged by the investigators capable to understand the contents of this clinical research and comply with them.
- Participants who are able to sign and date the Informed Consent Form before any clinical research procedure begins.
- Participants who are at least 20 years old at the time of giving the consent.
- Participants who are classified as outpatients.
Exclusion Criteria:
- Participants who have a history of taking once-weekly dosing of DPP-4 inhibitor (trelagliptin or omarigliptin).
- 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).
- Participants who are being treated with twice-daily dosing of DPP-4 inhibitor (vildagliptin or anagliptin).
- Participants who are being treated with anti-diabetic fixed-dose combination pill contained a DPP-4 inhibitor.
- Participants with moderate or severe renal impairment (for example, participant whose estimated glomerular filtration rate (eGFR) is below 60 mL/min/1.73m^2).
- 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).
- Participants who have a history of hypersensitivity or allergy to DPP-4 inhibitor.
- Participants with serious heart disease, cerebrovascular disorder, or participants with serious disease in the pancreas, blood, etc.
- Participants with unstable proliferative diabetic retinopathy.
- Participants with malignant tumor.
- Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
- Participants participating in other clinical studies.
- Participants who have been determined as inappropriate participants by the investigator.
Sites / Locations
- OCROM Clinic
- ToCROM Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Trelagliptin 100 mg + Alogliptin 25 mg
Alogliptin 25 mg + Trelagliptin 100 mg
Arm 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.
Outcomes
Primary Outcome Measures
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period
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
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors
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.
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)
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.
Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03231709
Brief Title
Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus
Acronym
TRINITY
Official Title
Treatment Preference for Weekly DPP-4 Inhibitors Versus Daily DPP-4 Inhibitors in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
February 9, 2018 (Actual)
Study Completion Date
February 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trelagliptin 100 mg + Alogliptin 25 mg
Arm Type
Experimental
Arm 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.
Arm Title
Alogliptin 25 mg + Trelagliptin 100 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Trelagliptin
Intervention Description
Trelagliptin tablets
Intervention Type
Drug
Intervention Name(s)
Alogliptin
Intervention Description
Alogliptin tablets
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have been diagnosed with type 2 diabetes mellitus.
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
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.
Participants whose glycosylated hemoglobin (HbA1c) value measured within 8 weeks prior to the time of informed consent (Week 0) is below 10.0%.
Participants who responded to Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent (Week 0).
Participants who were judged by the investigators capable to understand the contents of this clinical research and comply with them.
Participants who are able to sign and date the Informed Consent Form before any clinical research procedure begins.
Participants who are at least 20 years old at the time of giving the consent.
Participants who are classified as outpatients.
Exclusion Criteria:
Participants who have a history of taking once-weekly dosing of DPP-4 inhibitor (trelagliptin or omarigliptin).
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).
Participants who are being treated with twice-daily dosing of DPP-4 inhibitor (vildagliptin or anagliptin).
Participants who are being treated with anti-diabetic fixed-dose combination pill contained a DPP-4 inhibitor.
Participants with moderate or severe renal impairment (for example, participant whose estimated glomerular filtration rate (eGFR) is below 60 mL/min/1.73m^2).
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).
Participants who have a history of hypersensitivity or allergy to DPP-4 inhibitor.
Participants with serious heart disease, cerebrovascular disorder, or participants with serious disease in the pancreas, blood, etc.
Participants with unstable proliferative diabetic retinopathy.
Participants with malignant tumor.
Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
Participants participating in other clinical studies.
Participants who have been determined as inappropriate participants by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
OCROM Clinic
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
ToCROM Clinic
City
Shinjuku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Citations:
PubMed Identifier
31366262
Citation
Meguro S, Matsui S, Itoh H. Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial. Curr Med Res Opin. 2019 Dec;35(12):2071-2078. doi: 10.1080/03007995.2019.1651130. Epub 2019 Aug 22.
Results Reference
derived
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Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus
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