Type 2 diabetes mellitus
Conditions
Interventions
Investigational product
Nonproprietary name, etc.: TENELIA Tablets 20 mg (Teneligliptin hydrobromide hydrate tablets)
Drug/investigational product: Teneligliptin
Therapeutic category code: 396 Antidia
Sponsors
Mitsubishi Tanabe Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who can undergo long-term use and long-term observation of this drug and who are taking this drug for the first time for the indication of 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, precoma, or type 1 diabetes mellitus (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) Safety profile (type and timing of occurrence, incidence rate and person-time-based incidence rate), influence of patient background factors on adverse drug reaction risk (2) Change in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of important adverse drug reactions (adverse events) Adverse drug reaction (adverse event) profile (type and timing of occurrence, incidence rate and person-time-based incidence rate) | — |
Countries
JAPAN
Contacts
Public ContactYuka Yamada
Mitsubishi Tanabe Pharma Corporation
Outcome results
None listed