Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Trelagliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT04285983

Trelagliptin-4004

jRCT1080225091 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.

Full description

The drug being tested in this study is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure.

This study is an observational (non-interventional) study and will look at the long-term safety of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 100.

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

Enrollment: 89 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants must be type 2 diabetes mellitus patients meeting the following conditions: Have severe renal impairment or end-stage renal disease, with serum creatinine (mg/dL) or creatinine clearance (Ccr; mL/min) meeting the following criteria within 3 months before the start of treatment with this product

• Serum creatinine (mg/dL)*: male: > 2.4, female: > 2.0

• Ccr (mL/min): < 30 In patients with end-stage renal disease, this product may be administered irrespective of the time of hemodialysis.

  • Estimated values corresponding to the Ccr (for persons aged 60 years weighing 65 kg)

Exclusion criteria

1. Participants with any of the following contraindications for trelagliptin will be excluded:

2. Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus

3. Patient with severe infection, perioperative status, or serious trauma

4. Patient with a history of hypersensitivity to any ingredients of trelagliptin

Trial design

89 participants in 1 patient group

Trelagliptin 25 mg

Description:

Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.

Treatment:

Drug: Trelagliptin