Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Trelagliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT03555591

Trelagliptin-5001

JapicCTI-183980 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Full description

The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.

This multi-center observational trial will be conducted in Japan.

Enrollment: 3,198 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus patients

Exclusion criteria

1. Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
2. Have severe infection, perioperative status, or serious trauma
3. Have severe renal impairment or on dialysis due to end-stage renal disease
4. Have a history of hypersensitivity to any ingredients of this drug

Trial design

3,198 participants in 1 patient group

Trelagliptin 100 mg

Description:

Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.

Treatment:

Drug: Trelagliptin