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Nesina tablets special drug use surveillance "Type 2 diabetes mellitus: Combination therapy with sulfonylurea"

Nesina tablets special drug use surveillance "Type 2 diabetes mellitus: Combination therapy with sulfonylurea"

Status
Unknown
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080222219
Enrollment
1000
Registered
2013-09-10
Start date
2013-09-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

Sponsors

TAKEDA PHARMACEUTICAL COMPANY LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients who did not adequately respond to the following treatment •Treatment with sulfonylurea in addition to diet therapy and exercise therapy

Exclusion criteria

Exclusion criteria: Patients contraindicated for Nesina (1) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus [these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.] (2) Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury [blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.] (3) Patients with a history of hypersensitivity to any ingredient of Nesina

Design outcomes

Primary

MeasureTime frame
Adverse event (adverse reactions), HbA1c Frequency of adverse events (adverse reactions), HbA1c time profile Primary timeframe 12 months

Secondary

MeasureTime frame
Fasting blood glucose Changes in fasting blood glucose Secondary timeframe 12 months

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026