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

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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:
Information provided by (Responsible Party):
Takeda

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 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

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098733


Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02098733     History of Changes
Other Study ID Numbers: 097-011
JapicCTI-142438 ( Registry Identifier: Japic CTI )
JapicCTI-R150734 ( Registry Identifier: JapicCTI )
First Posted: March 28, 2014    Key Record Dates
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