NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus patients whose blood glucose levels are not adequately controlled by diet and exercise therapies
Date of first enrollment	12/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : SMP-862 (metformin hydrochloride) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Efficacy: HbA1c etc
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 74age old
Gender	Both
Include criteria	<Inclusion criteria> Patients with type 2 diabetes mellitus who satisfy the following inclusion criteria -Patients who are undergoing only diet and exercise therapies -Patients whose HbA1c levels are 6.5% <= HbA1c < 12.0%, and are stable over 4 weeks -Patients aged 20 to less than 75 -Outpatients etc. <Exclusion criteria> -Patients with hepatic dysfunction -Patients with renal dysfunction -Patients with severe cardiovascular or pulmonary dysfunction, patients who have other conditions which are likely to be associated with hypoxemia -Patients with a history of lactic acidosis -Patients who are dehydrated or patients who have severe gastrointestinal disorders such as diarrhoea or vomiting which are likely to cause dehydration etc.
Exclude criteria