N/A
Completed N=246
Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
Source: ClinicalTrials.gov NCT02181842 ↗Enrolled (actual)
246
Serious AEs
6.6%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL) — 42.2 Percentage of Participants
Summary
The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL) |
42.2 | — |
| PRIMARY Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %) |
40.0 | — |
| PRIMARY Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week |
-6.9 | — |
| PRIMARY Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week |
-5 | — |
| PRIMARY Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week |
3.97 | — |
| PRIMARY Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week |
-1.85 | — |
| PRIMARY Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone |
-0.84; -0.73; -0.98 | — |
| PRIMARY Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c |
-0.36; -0.83; -1.17 | — |
| PRIMARY Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender |
-0.59; -1.11 | — |
| PRIMARY Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI |
-0.6; -0.73; -0.81; -1.3 | — |
| PRIMARY Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs |
-0.68; -0.8 | — |
| PRIMARY Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point |
172.62; 147.32 | — |
| PRIMARY Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point |
7.83; 7.09 | — |
| SECONDARY Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) |
23 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetic patients with a prior history of cerebral infarction who meet all the following conditions, [1] to [3], at the time of enrollment in the survey:
- First onset of cerebral infarction was at least 24 weeks prior to enrollment
- HbA1c values ≥ 6.5% within 12 weeks prior to the start of treatment with Pioglitazone Tablets
- No prior history of treatment with Pioglitazone Tablets since the first onset of cerebral infarction
Exclusion Criteria
- Patients who meet any of the following conditions, [1] to [5], shall be excluded from the survey:
- Contraindication for Actos Tablets
- Prior history of recurrence of cerebral infarction
- Prior history of cerebral hemorrhage or subarachnoid hemorrhage
- Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease
- Reduced cardiac function (defined as an ejection fraction [EF] ≤ 40%)
Data sourced from ClinicalTrials.gov (NCT02181842). 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.