NCT03014479

Brief Summary

The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

27 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

January 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 25, 2019

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

January 5, 2017

Results QC Date

October 19, 2018

Last Update Submit

December 7, 2023

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study

    DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.

    Baseline (Week 0), up to the end of study (Week 12)

Secondary Outcomes (20)

  • Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 1: Burden on Social Activities and Daily Activities] at Each Assessment Time Point

    Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

  • Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point

    Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

  • Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point

    Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

  • Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point

    Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)

  • Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point

    Baseline (Week 0), up to Week 4, 12

  • +15 more secondary outcomes

Study Arms (2)

Trelagliptin

EXPERIMENTAL

Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.

Drug: Trelagliptin

Daily DPP-4 inhibitors

ACTIVE COMPARATOR

An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.

Drug: Daily DPP-4 inhibitor

Interventions

TrelagliptinDRUG

Trelagliptin 100 mg or 50 mg

Trelagliptin
Daily DPP-4 inhibitorDRUG

Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin

Daily DPP-4 inhibitors

Eligibility Criteria

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

You may qualify if:

  • Participants diagnosed as type 2 diabetes.
  • Participants with a stable diet and exercise therapy only for at least 12 weeks prior to the start of the screening period.
  • Participants who require a DPP-4 inhibitor treatment.
  • Participants with Hemoglobin A1c (HbA1c) \>=6.5 % and \<10.0 % at the start of the screening period.
  • Participants who completed DTR-QOL questionnaire at the start of the screening period.
  • Participants who have received less than 2 types of medication for treatment of comorbidities (such as hypertension or dyslipidemia) at the start of the screening period (any number of daily doses).
  • Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.
  • Participants who can provide the written informed consent prior to the initiation of any study procedures.
  • Participants aged \>=20 years at the time of informed consent.
  • Outpatient.

You may not qualify if:

  • Participants who are receiving any oral anti-diabetic medication for the treatment of type 2 diabetes at the start of the screening period.
  • Participants diagnosed with type 1 diabetes.
  • Participants with severe renal impairment or renal failure (e.g., estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 or on dialysis).
  • Participants with serious heart disease or cerebrovascular disorder, or serious pancreatic, blood, or other disease.
  • Participants with a history of gastrointestinal resection.
  • Participant with a proliferative diabetic retinopathy.
  • Participant with malignancy.
  • Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
  • Pregnant, lactating or planning pregnancy during the study period.
  • Participants who may need to add or discontinue concomitant medication or change the dose during the study period.
  • Participants who will require treatment with a prohibited concomitant medication during the study period.
  • Participants participating in other clinical studies.
  • Participants assessed ineligible in the study by the principal investigator or the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Takeda Selected Site 17

Nagoya, Aichi-ken, Japan

Location

Takeda Selected Site 18

Nagoya, Aichi-ken, Japan

Location

Takeda Selected Site 25

Obata, Gunma, Japan

Location

Takeda Selected Site 9

Kobe, Hyōgo, Japan

Location

Takeda Selected Site 27

Koga, Ibaraki, Japan

Location

Takeda Selected Site 14

Kawasaki, Kanagawa, Japan

Location

Takeda Selected Site 11

Sagamihara, Kanagawa, Japan

Location

Takeda Selected Site 10

Yamato, Kanagawa, Japan

Location

Takeda Selected Site 4

Sendai, Miyagi, Japan

Location

Takeda Selected Site 5

Sendai, Miyagi, Japan

Location

Takeda Selected Site 3

Kashihara, Nara, Japan

Location

Takeda Selected Site 15

Kashihara, Osaka, Japan

Location

Takeda Selected Site 1

Suita, Osaka, Japan

Location

Takeda Selected Site 24

Okegawa, Saitama, Japan

Location

Takeda Selected Site 26

Oyama, Tochigi, Japan

Location

Takeda Selected Site 23

Adachi-ku, Tokyo, Japan

Location

Takeda Selected Site 6

Chuo-ku, Tokyo, Japan

Location

Takeda Selected Site 7

Chuo-ku, Tokyo, Japan

Location

Takeda Selected Site 22

Edogawa-ku, Tokyo, Japan

Location

Takeda Selected Site 19

Musashino, Tokyo, Japan

Location

Takeda Selected Site 21

Ōta-ku, Tokyo, Japan

Location

Takeda Selected Site 12

Shibuya-ku, Tokyo, Japan

Location

Takeda Selected Site 13

Shinagawa-ku, Tokyo, Japan

Location

Takeda Selected Site 20

Shinagawa-ku, Tokyo, Japan

Location

Takeda Selected Site 2

Shinjuku-ku, Tokyo, Japan

Location

Takeda Selected Site 8

Shinjuku-ku, Tokyo, Japan

Location

Takeda Selected Site 16

Osaka, Japan

Location

Related Publications (1)

  • Ishii H, Suzaki Y, Miyata Y, Matsui S. Randomized Multicenter Evaluation of Quality of Life and Treatment Satisfaction in Type 2 Diabetes Patients Receiving Once-Weekly Trelagliptin Versus a Daily Dipeptidyl Peptidase-4 Inhibitor. Diabetes Ther. 2019 Aug;10(4):1369-1380. doi: 10.1007/s13300-019-0643-1. Epub 2019 Jun 18.

    PMID: 31214997DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

trelagliptin

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 9, 2017

Study Start

February 18, 2017

Primary Completion

October 21, 2017

Study Completion

October 21, 2017

Last Updated

December 22, 2023

Results First Posted

February 25, 2019

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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(27)