NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	17/02/2014
Target sample size	210
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Sonias Combination Tablets LD (pioglitazone/glimepiride 15mg/1mg) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : The usual adult dosage is one Sonias Combination tablet LD (15 mg/1 mg of pioglitazone/glimepiride) is administered orally once daily before or after breakfast.

Outcome(s)

Primary Outcome

Frequency of adverse drug reactions Primary timeframeFor 12 months The frequency of adverse drug reactions by type, seriousness, time to onset tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with the study drug are defined as adverse drug reactions.

Secondary Outcome

Changes from the baseline in diabetes-related test values Secondary timeframeBaseline and month 12 Tabulation of the diabetes-related test values (i.e., glycosylated hemoglobin [HbA1c], fasting blood glucose level, and fasting insulin level) and the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline).

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with type 2 diabetes mellitus for whom treatment with pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) is considered inefficacious as per physician's assessment and for whom long-term treatment with Sonias Combination Tablets LD is considered necessary
Exclude criteria	(1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides