Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098733
• Other study ID #: 097-011
• Secondary ID: JapicCTI-142438
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: August 20, 2014
• Start date: June 2011
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of of long-term use of Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Description:

This a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting.

The usual adult dosage is one tablet of Sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1168
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes mellitus for whom a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with Sonias Combination Tablets is considered necessary

Exclusion 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Pioglitazone/glimepiride
Pioglitazone/glimepiride combination tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse drug reactions	Frequency, seriousness, and time to onset of adverse drug reactions 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 a medicinal product are defined as adverse drug reactions.	For 12 months	Yes
Secondary	Change from baseline in glycosylated hemoglobin (HbA1c)	Tabulation of HbA1c values and the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline)	Baseline and Month 12	No
Secondary	Change from baseline in fasting blood glucose level	Tabulation of fasting blood glucose level and the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline)	Baseline and Month 12	No
Secondary	Change from Baseline in fasting insulin level	Tabulation of 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)	Baseline and Month 12	No