NCT03231709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

August 18, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 10, 2019

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

July 25, 2017

Results QC Date

February 7, 2019

Last Update Submit

December 7, 2023

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors

    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)

    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)

    At Week 16

Study Arms (2)

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.

Drug: TrelagliptinDrug: Alogliptin

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.

Drug: TrelagliptinDrug: Alogliptin

Interventions

TrelagliptinDRUG

Trelagliptin tablets

Alogliptin 25 mg + Trelagliptin 100 mgTrelagliptin 100 mg + Alogliptin 25 mg
AlogliptinDRUG

Alogliptin tablets

Alogliptin 25 mg + Trelagliptin 100 mgTrelagliptin 100 mg + Alogliptin 25 mg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OCROM Clinic

Suita, Osaka, Japan

Location

ToCROM Clinic

Shinjuku, Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31366262DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

trelagliptinalogliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Medical Director
Organization
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 27, 2017

Study Start

August 18, 2017

Primary Completion

February 9, 2018

Study Completion

February 9, 2018

Last Updated

December 22, 2023

Results First Posted

May 10, 2019

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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.

Locations

JP(2)