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

• Status: Completed
• Trial end date: 2017-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Dipeptidyl-Peptidase IV Inhibitors

Criteria

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.