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Completed

NCT Number: NCT02098733

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pioglitazone/glimepiride

Drug

Pioglitazone/glimepiride combination tablets

Other names: Sonias combination tablets

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2014
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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