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"

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Takeda
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Updated on 16 February 2024
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renal failure
nephropathy
renal impairment

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.

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.

Details
Condition NIDDM, Diabetes Mellitus
Age 100years or below
Treatment Trelagliptin
Clinical Study IdentifierNCT04285983
SponsorTakeda
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Participants with any of the following contraindications for trelagliptin will be
excluded
Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus
Patient with severe infection, perioperative status, or serious trauma
Patient with a history of hypersensitivity to any ingredients of trelagliptin
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