NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	10/10/2013
Target sample size	3000
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Liovel Combination Tablets (alogliptin/pioglitazone) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with type 2 diabetes mellitus
Exclude criteria	Patients meeting any of the following criteria will be excluded: 1. Patients with current cardiac failure or a past history of cardiac failure 2. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus 3. Patients with serious hepatic dysfunction 4. Patients with serious renal dysfunction 5. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury 6. Patients with a history of hypersensitivity to any ingredients of Liovel 7. Pregnant or possibly pregnant wome