NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	24/09/2013
Target sample size	1000
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Nesina tablet (alogliptin) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : The usual adult dosage for oral use is 1 Nesina tablet (25 mg of alogliptin) once daily.

Outcome(s)

Primary Outcome	Adverse event (adverse reactions), HbA1c Frequency of adverse events (adverse reactions), HbA1c time profile Primary timeframe 12 months
Secondary Outcome	Fasting blood glucose Changes in fasting blood glucose Primary timeframe 12 months

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Inclusion criteria: Patients who did not adequately respond to the following treatment Treatment with biguanides in addition to diet therapy and exercise therapy
Exclude 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