N/A
Completed N=899
Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"
Source: ClinicalTrials.gov NCT02003014 ↗Enrolled (actual)
899
Serious AEs
1.4%
Results posted
Nov 2016
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions — 79 participants
Summary
To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions |
79 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
1 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
8.34; -0.71; -0.79; -0.85; -0.91; 0.85 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
174.1; -27.4; -27.9; -20.8; -28.4; -28.1 | — |
| SECONDARY Change From Baseline in Body Weight |
68.971; 0.667; 1.180; 1.440; 1.407; 1.465 | — |
| SECONDARY Change From Baseline in Immunoreactive Insulin (IRI) |
10.320; -1.390; -2.438; -2.970; -1.774; -1.077 | — |
| SECONDARY Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) |
3.92; -0.85; -1.41; -1.49; -1.26; -0.75 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
- Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
- Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment
Exclusion Criteria
- Patients who have received Actos Tablets within the past 3 months.
- Patients who started treatment with biguanides and Actos Tablets simultaneously
- Patients who discontinued biguanides and switched to Actos Tablets treatment.
- Patients who received additional biguanides after the start of Actos Tablets treatment
- Patients with contraindications to Actos Tablets treatment
Data sourced from ClinicalTrials.gov (NCT02003014). 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.