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Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	07/05/2013
Target sample size	10000
Countries of recruitment	JAPAN
Study type	Observational
Intervention(s)	Investigational product Nonproprietary name, etc.: TENELIA Tablets 20 mg (Teneligliptin hydrobromide hydrate tablets) Drug/investigational product: Teneligliptin Therapeutic category code: 396 Antidiabetic agents Dosage and administration, method of use: The usual adult dosage is 20 mg of teneligliptin administered orally once daily. If efficacy is insufficient, the dose may be increased to 40 mg once daily with close monitoring of clinical course.

Outcome(s)

Primary Outcome	(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 Outcome	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)

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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