N/A
Completed N=294
Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
Source: ClinicalTrials.gov NCT02098746 ↗Enrolled (actual)
294
Serious AEs
0.7%
Results posted
Feb 2016
Primary outcomePrimary: Frequency of Adverse Drug Reactions — 1; 7; 1; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Drug Reactions |
1; 7; 1; 1; 6 | — |
| PRIMARY Frequency of Serious Adverse Drug Reactions |
— | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.83; -0.84; -0.83; -0.62; -0.92 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose Level |
-15.9; -23.2; -12.7; -17.0; -17.7 | — |
| SECONDARY Change From Baseline in Fasting Insulin Level |
1.66; -0.25; 1.32; -0.29; 0.98 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02098746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.