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

• ClinicalTrials.gov Identifier: NCT02098733
• Recruitment Status: Completed
• First Posted: March 28, 2014
• Results First Posted: April 15, 2016
• Last Update Posted: April 15, 2016
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Type 2 Diabetes	Drug: Pioglitazone/glimepiride

Detailed 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).

Study Design

• Study Type: Observational
• Actual Enrollment: 1168 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for in Type 2 Diabetes Mellitus
• Study Start Date: June 2011
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pioglitazone/glimepiride; Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast	Drug: Pioglitazone/glimepiride; Pioglitazone/glimepiride combination tablets; Other Name: Sonias combination tablets

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Drug Reactions [ Time Frame: For 12 months ]
   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.

Secondary Outcome Measures :

1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, and Months 3, 6, 9, 12 and at Final Assessment ]
   Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.
2. Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, and Months 3, 6, 9, 12 and at Final Assessment ]
   Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.
3. Change From Baseline in Fasting Blood Glucose Level [ Time Frame: Baseline, Months 3, 6, 9, 12 and at Final Assessment ]
   Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.
4. Fasting Blood Glucose Level [ Time Frame: Baseline, Months 3, 6, 9, 12 and at Final Assessment ]
   Tabulated fasting blood glucose level from baseline at each test time point.
5. Change From Baseline in Fasting Insulin Level [ Time Frame: Baseline, Months 3, 6, 9, 12 and at Final Assessment ]
   Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.
6. Fasting Insulin Level [ Time Frame: Baseline, Months 3, 6, 9, 12 and at Final Assessment ]
   Tabulated fasting insulin level at each test time point.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Takeda

Investigators

• Study Chair: Postmarketing Group Manager; Takeda

More Information

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02098733
• Other Study ID Numbers: 097-011; JapicCTI-142438 ( Registry Identifier: Japic CTI ); JapicCTI-R150734 ( Registry Identifier: JapicCTI )
• First Posted: March 28, 2014
• Results First Posted: April 15, 2016
• Last Update Posted: April 15, 2016
• Last Verified: March 2016

Keywords provided by Takeda:

Pharmacological therapy

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pioglitazone; Glimepiride; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors