NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus whose blood glucose levels are not adequately controlled by pioglitazone in addition to diet and exercise therapies
Date of first enrollment	23/07/2010
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : SMP-508 (repaglinide) 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	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with type 2 diabetes mellitus who participated in the previous study "Phase 3 study on combinational therapy of SMP-508 with pioglitazone in patients with type 2 diabetes mellitus", and meet all of the following requirements. -Patients who underwent the surveys, observations, and tests, etc. scheduled to be conducted in week 16 of the previous study. -Patients who, prior to admission to the study, voluntarily agree to participate in the study after receiving an explanation of the study objectives, methods, and potential risks. -Patients who provide written informed consent.
Exclude criteria	-Women who are pregnant or have a potential of pregnancy during the study, women who are at risk of pregnancy due to lack of appropriate contraceptive measures, and lactating mothers -Patients who will require surgery. -Patients whom the investigator or subinvestigator considers to be unsuitable for administration to the study for any other reason.