NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	16/10/2009
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : SK-0403 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral Generic name etc : Voglibose INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Efficacy and Safety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 74age old
Gender	Both
Include criteria	Patients with type 2 diabetes who have inadequate glycemic control on diet therapy or diet plus exercise therapy HbA1C of >=6.5%, but < 10.0% measured during the run-in period
Exclude criteria	Patients with type 1 diabetes mellitus Patients require insulin or oral antidiabetic drug therapy Patients with, or a history of, clinically significant cardiac, renal, hepatic, pulmonary, pancreatic and macrovascular disease Patients have a known allergy or hypersensitivity to voglibose