SAPPHIRE

Real-world safety and effectiveness of canagliflozin treatment for type 2 diabetes mellitus in Japan: SAPPHIRE, a long-term, large-scale post-marketing surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080222994

Enrollment

10000

Registered

2015-10-23

Start date

2014-12-17

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

Investigational product Nonproprietary name, etc.: Canaglu Tablets 100 mg (canagliflozin) Drug/investigational product: Canagliflozin Therapeutic category code: 396 Antidiabetic agents Dosage and admi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: First time user of this drug in accordance with the indication for type 2 diabetes mellitus

Exclusion criteria

Exclusion criteria: Patients contraindicated for administration of this drug (1)Patients with a history of hypersensitivity to any ingredients of this drug (2)Patients with severe ketosis, diabetic coma, or precoma (3)Patients with severe infection, perioperative patients, and patients with serious trauma

Design outcomes

Primary

Measure	Time frame
(1)Occurrence of adverse drug reactions, (2) HbA1c (1)Influence of patient background factors on adverse reaction profile (Type and timing of onset, incidence and incidence based on person-time method) and risk of onset of adverse reactions (2)Change in HbA1c	—

Countries

Japan

Contacts

Public ContactMamoru Hoshi

Mitsubishi Tanabe Pharma Corporation

mtpc-pv-dm@ml.mt-pharma.co.jp+81-6-6205-5223

Outcome results

None listed

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