Clinical trial NCT04285983: 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"
Official title: Specified Drug Use Surveillance on Zafatek Tablets 25 mg -Surveillance on Long-Term Use of Trelagliptin Tablets in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-Stage Renal Failure-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure as part of routine medical care.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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:

1. Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus
2. Patient with severe infection, perioperative status, or serious trauma
3. Patient with a history of hypersensitivity to any ingredients of trelagliptin

Primary outcomes:
measure: Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
timeFrame: Up to Month 12
measure: Number of Participants Who Had One or More Serious ADRs
timeFrame: Up to Month 12
measure: Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs
timeFrame: Up to Month 12
measure: Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs
timeFrame: Up to Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: