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

Treatment Preference for Weekly DPP-4 Inhibitors Versus Daily DPP-4 Inhibitors in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Trelagliptin; Drug: Alogliptin

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan
      • OCROM Clinic
  • Tokyo
    • Shinjuku, Tokyo, Japan
      • ToCROM Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
3. 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.
4. Participants whose glycosylated hemoglobin (HbA1c) value measured within 8 weeks prior to the time of informed consent (Week 0) is below 10.0%.
5. Participants who responded to Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent (Week 0).
6. Participants who were judged by the investigators capable to understand the contents of this clinical research and comply with them.
7. Participants who are able to sign and date the Informed Consent Form before any clinical research procedure begins.
8. Participants who are at least 20 years old at the time of giving the consent.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2017
• Primary Completion (Actual): February 9, 2018
• Study Completion (Actual): February 9, 2018

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Alogliptin
• Other Study ID Numbers: Trelagliptin-4003; U1111-1197-5821 (Other Identifier: WHO); JapicCTI-173662 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No