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

Takeda

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Daily DPP-4 inhibitor; Drug: Trelagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03014479

JapicCTI-173482 (Registry Identifier)

U1111-1189-9256 (Registry Identifier)

Trelagliptin-4002

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 219 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 2 patient groups

Trelagliptin

Experimental group

Description:

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.

Treatment:

Drug: Trelagliptin

Daily DPP-4 inhibitors

Active Comparator group

Description:

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

Treatment:

Drug: Daily DPP-4 inhibitor