N/A
Completed N=1,067
Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Source: ClinicalTrials.gov NCT02068508 ↗Enrolled (actual)
1,067
Serious AEs
1.1%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) — 213 Participants
Summary
The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) |
213 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-26.2; -23.9; -21.7; -21.4; -23.8 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.62; -0.75; -0.77; -0.75; -0.72 | — |
| SECONDARY Change From Baseline in Fasting Triglycerides |
-20.7; -19.8; -28.4; -8.5; -16.6 | — |
| SECONDARY Change From Baseline in HDL Cholesterol |
3.32; 1.98; 1.79; 1.35; 2.04 | — |
| SECONDARY Change From Baseline in LDL Cholesterol |
-0.96; -0.16; -0.68; -0.33; -0.82 | — |
| SECONDARY Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points |
510; 359; 68; 16; 379; 256 | — |
Eligibility Criteria
Inclusion Criteria
Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment.
- Participants treated with an insulin product for at least 4 weeks
- Participants who started Actos Tablets for the first time after the start of an insulin product
- Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets
Exclusion Criteria
Participants with contraindications to Actos Tables and insulin products treatment
Data sourced from ClinicalTrials.gov (NCT02068508). 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.