--- title: Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone nct_id: NCT02098746 overall_status: COMPLETED sponsor: Takeda study_type: OBSERVATIONAL primary_condition: Type 2 Diabetes canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02098746.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02098746" ct_last_update_post_date: 2016-10-18 last_seen_at: "2026-05-12T07:01:00.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone **Official Title:** Sonias Combination Tablets LD Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone **NCT ID:** [NCT02098746](https://clinicaltrials.gov/study/NCT02098746) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 294 - **Lead Sponsor:** Takeda - **Conditions:** Type 2 Diabetes - **Start Date:** 2011-06 - **Completion Date:** 2014-07 - **CT.gov Last Update:** 2016-10-18 ## Brief Summary The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) in the routine clinical setting. ## Detailed Description This is a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day). The usual adult dosage is one tablet (15 mg/1 mg of pioglitazone/glimepiride) administered orally once daily before or after breakfast. ## Eligibility - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Patients with type 2 diabetes mellitus for whom treatment with pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) is considered inefficacious as per physician's assessment and for whom long-term treatment with pioglitazone/glimepiride 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 ``` ## Arms - **Pioglitazone/glimepiride** — Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast. ## Interventions - **Pioglitazone/glimepiride** (DRUG) — Pioglitazone/glimepiride combination tablets ## Primary Outcomes - **Frequency of Adverse Drug Reactions** _(time frame: 12 months)_ — Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were 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. - **Frequency of Serious Adverse Drug Reactions** _(time frame: 12 months)_ — Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were 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. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. ## Secondary Outcomes - **Change From Baseline in Glycosylated Hemoglobin (HbA1c)** _(time frame: Baseline, Months 3, 6, 9, 12 and at Final assessment)_ - **Change From Baseline in Fasting Blood Glucose Level** _(time frame: Baseline, Months 3, 6, 9, 12 and at Final assessment)_ - **Change From Baseline in Fasting Insulin Level** _(time frame: Baseline, Months 3, 6, 9, 12 and at Final assessment)_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02098746.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02098746* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*