N/A
Completed N=1,168
Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02098733 ↗Enrolled (actual)
1,168
Serious AEs
2.0%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions — 13; 4; 1; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
13; 4; 1; 1; 1; 2 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.45; -0.55; -0.56; -0.57; -0.57 | — |
| SECONDARY Glycosylated Hemoglobin (HbA1c) |
7.70; 7.25; 7.14; 7.08; 7.12; 7.13 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose Level |
-16.7; -14.3; -15.7; -12.5; -16.4 | — |
| SECONDARY Fasting Blood Glucose Level |
147.2; 130.2; 131.7; 129.2; 126.8; 130.9 | — |
| SECONDARY Change From Baseline in Fasting Insulin Level |
-0.24; 0.02; -0.60; 0.58; -0.01 | — |
| SECONDARY Fasting Insulin Level |
5.78; 5.38; 5.48; 5.40; 6.57; 5.77 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02098733). 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.