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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1197-5821 | Other Identifier | WHO | |
| JapicCTI-173662 | Registry Identifier | JapicCTI |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trelagliptin 100 mg + Alogliptin 25 mg | Experimental | 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. |
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| Alogliptin 25 mg + Trelagliptin 100 mg | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trelagliptin | Drug | Trelagliptin tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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).
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:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OCROM Clinic | Suita | Osaka | Japan | |||
| ToCROM Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31366262 | Derived | 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. |
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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.
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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.
Participants took part in the study at 2 investigative sites in Japan from 18 August 2017 to 4 February 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Alogliptin 25 mg + Trelagliptin 100 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2017 | Feb 7, 2019 |
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| Alogliptin | Drug | Alogliptin tablets |
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| At Week 16 |
| 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. | At Week 16 |
| 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. | At Week 16 |
| Shinjuku |
| Tokyo |
| Japan |
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. |
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| NOT COMPLETED |
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| Treatment Period 2 |
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Full analysis set (FAS) included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
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| Smoking Habits | Count of Participants | Participants |
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| Alcohol intake history | Count of Participants | Participants |
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| Duration of diabetes mellitus | Mean duration between the first diagnosis of type 2 diabetes mellitus and the start of the study was reported. | Count of Participants | Participants |
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| Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) | NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. | Mean | Standard Deviation | percent |
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| Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent | DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Reported data were calculated by questions excluding Questions 2 and 3, two questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences. | Mean | Standard Deviation | score on a scale |
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| Work status | Count of Participants | Participants |
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| Presence of Cohabiter | Count of Participants | Participants |
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| Experience in Educational Hospitalization on Diabetes | Count of Participants | Participants |
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| Compliance With DPP-4 Inhibitors During 4-Week Before Start of Treatment | Count of Participants | Participants |
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| Number of Oral Drugs/Day at the Start of the Treatment Period, Excluding Study Drug | Count of Participants | Participants |
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| Complication of Metabolic Syndrome | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization. | Posted | Count of Participants | Participants | At Week 16 |
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| Secondary | 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. | FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization. | Posted | Count of Participants | Participants | At Week 16 |
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| Secondary | 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. | FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization. | Posted | Count of Participants | Participants | At Week 16 |
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| Secondary | 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. | FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization. | Posted | Count of Participants | Participants | At Week 16 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Trelagliptin 100 mg | Trelagliptin 100 mg tablets, orally, once a week for 8 weeks in either Period 1 or 2. | 0 | 59 | 1 | 59 | 4 | 59 |
| EG001 | Alogliptin 25 mg | Alogliptin 25 mg tablets, orally, once a day for 8 weeks in either Period 1 or 2. | 0 | 60 | 0 | 60 | 1 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 20.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 20.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda (Note: This product was divested to Teijin Pharma Limited in 2023) | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2018 | Feb 7, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000595449 | trelagliptin |
| C520853 | alogliptin |
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| Alogliptin |
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| Neither Trelagliptin nor Alogliptin |
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| OG002 | Alogliptin Preference | Participants who prefer alogliptin 25 mg, tablets, once a day. |
| OG003 | Neither Trelagliptin Nor Alogliptin | Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day. |
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| OG002 | Alogliptin Preference | Participants who prefer alogliptin 25 mg, tablets, once a day. |
| OG003 | Neither Trelagliptin Nor Alogliptin | Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day. |
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| OG002 | Alogliptin Preference | Participants who prefer alogliptin 25 mg, tablets, once a day. |
| OG003 | Neither Trelagliptin Nor Alogliptin | Participants who prefer neither trelagliptin 100 mg, tablets, once a week nor alogliptin 25 mg, tablets once a day. |
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