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Trial record 1 of 1 for:    097-011
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Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02098733
First Posted: March 28, 2014
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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 Intervention
Type 2 Diabetes Drug: Pioglitazone/glimepiride

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Fasting Insulin Level [ Time Frame: Baseline, Months 3, 6, 9, 12 and at Final Assessment ]
    Tabulated fasting insulin level at each test time point.


Enrollment: 1168
Study Start Date: June 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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
  More Information

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 Submitted: March 25, 2014
First Posted: March 28, 2014
Results First Submitted: December 16, 2015
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