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Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT03014479

Last Updated: 2023-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-18

Study Completion Date

2017-10-21

Brief Summary

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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.

Detailed Description

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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. Eligible participants will be randomized to either the study drug (trelagliptin) group or the comparative drug (daily DPP-4 inhibitor) group. Treatment burden will be assessed using Diabetes Therapy Related -QOL (DTR-QOL) questionnaire and Diabetes Treatment Satisfaction Questionnaire (DTSQ).

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trelagliptin

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.

Group Type EXPERIMENTAL

Trelagliptin

Intervention Type DRUG

Trelagliptin 100 mg or 50 mg

Daily DPP-4 inhibitors

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

Group Type ACTIVE_COMPARATOR

Daily DPP-4 inhibitor

Intervention Type DRUG

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

Interventions

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Trelagliptin

Trelagliptin 100 mg or 50 mg

Intervention Type DRUG

Daily DPP-4 inhibitor

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participants diagnosed as type 2 diabetes.
2. Participants with a stable diet and exercise therapy only for at least 12 weeks prior to the start of the screening period.
3. Participants who require a DPP-4 inhibitor treatment.
4. Participants with Hemoglobin A1c (HbA1c) \>=6.5 % and \<10.0 % at the start of the screening period.
5. Participants who completed DTR-QOL questionnaire at the start of the screening period.
6. 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).
7. 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.
8. Participants who can provide the written informed consent prior to the initiation of any study procedures.
9. Participants aged \>=20 years at the time of informed consent.
10. Outpatient.

Exclusion Criteria

1. Participants who are receiving any oral anti-diabetic medication for the treatment of type 2 diabetes at the start of the screening period.
2. Participants diagnosed with type 1 diabetes.
3. 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).
4. Participants with serious heart disease or cerebrovascular disorder, or serious pancreatic, blood, or other disease.
5. Participants with a history of gastrointestinal resection.
6. Participant with a proliferative diabetic retinopathy.
7. Participant with malignancy.
8. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
9. Pregnant, lactating or planning pregnancy during the study period.
10. Participants who may need to add or discontinue concomitant medication or change the dose during the study period.
11. Participants who will require treatment with a prohibited concomitant medication during the study period.
12. Participants participating in other clinical studies.
13. Participants assessed ineligible in the study by the principal investigator or the investigator.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda Selected Site 17

Nagoya, Aichi-ken, Japan

Site Status

Takeda Selected Site 18

Nagoya, Aichi-ken, Japan

Site Status

Takeda Selected Site 25

Obata, Gunma, Japan

Site Status

Takeda Selected Site 9

Kobe, Hyōgo, Japan

Site Status

Takeda Selected Site 27

Koga, Ibaraki, Japan

Site Status

Takeda Selected Site 14

Kawasaki, Kanagawa, Japan

Site Status

Takeda Selected Site 11

Sagamihara, Kanagawa, Japan

Site Status

Takeda Selected Site 10

Yamato, Kanagawa, Japan

Site Status

Takeda Selected Site 4

Sendai, Miyagi, Japan

Site Status

Takeda Selected Site 5

Sendai, Miyagi, Japan

Site Status

Takeda Selected Site 3

Kashihara, Nara, Japan

Site Status

Takeda Selected Site 15

Kashihara, Osaka, Japan

Site Status

Takeda Selected Site 1

Suita, Osaka, Japan

Site Status

Takeda Selected Site 24

Okegawa, Saitama, Japan

Site Status

Takeda Selected Site 26

Oyama, Tochigi, Japan

Site Status

Takeda Selected Site 23

Adachi-ku, Tokyo, Japan

Site Status

Takeda Selected Site 6

Chuo-ku, Tokyo, Japan

Site Status

Takeda Selected Site 7

Chuo-ku, Tokyo, Japan

Site Status

Takeda Selected Site 22

Edogawa-ku, Tokyo, Japan

Site Status

Takeda Selected Site 19

Musashino, Tokyo, Japan

Site Status

Takeda Selected Site 21

Ōta-ku, Tokyo, Japan

Site Status

Takeda Selected Site 12

Shibuya-ku, Tokyo, Japan

Site Status

Takeda Selected Site 13

Shinagawa-ku, Tokyo, Japan

Site Status

Takeda Selected Site 20

Shinagawa-ku, Tokyo, Japan

Site Status

Takeda Selected Site 2

Shinjuku-ku, Tokyo, Japan

Site Status

Takeda Selected Site 8

Shinjuku-ku, Tokyo, Japan

Site Status

Takeda Selected Site 16

Osaka, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 31214997 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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JapicCTI-173482

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1189-9256

Identifier Type: REGISTRY

Identifier Source: secondary_id

Trelagliptin-4002

Identifier Type: -

Identifier Source: org_study_id