N/A
Completed N=1,103
Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02024971 ↗Enrolled (actual)
1,103
Serious AEs
1.7%
Results posted
Nov 2016
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions — 1; 1; 1; 2 participants
Summary
The purpose of this study is to investigate the safety and efficacy of long-term use of pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride combined with metformin hydrochloride is considered suitable.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
1; 1; 1; 2; 1; 1 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.47; -0.53; -0.55; -0.60; -0.58 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-14.0; -15.5; -11.7; -17.3; -17.9 | — |
| SECONDARY Change From Baseline in Fasting Insulin |
-1.768; -2.374; -1.018; -2.524; -2.107 | — |
Eligibility Criteria
Inclusion Criteria
-Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is suitable and for whom long-term treatment with Metact Combination Tablets is considered necessary.
Exclusion Criteria
-Patients for whom pioglitazone hydrochloride and metformin hydrochloride are contraindicated.
- Patients with cardiac insufficiency or a history of cardiac insufficiency
- Patients with the following conditions (i) Patients with a history of lactic acidosis (ii) Dialysis patients (including peritoneal dialysis) (iii) Patients with cardiovascular conditions such as shock, cardiac insufficiency, myocardial infarction, and pulmonary embolism; patients with severely impaired pulmonary function; and patients with other conditions fostering susceptibility to hypoxemia (iv) Patients with excessive alcohol consumption (v) Patients with dehydration (vi) Patients with gastrointestinal disorders such as diarrhea and vomiting (vii) Elderly patients
- Patients with renal impairment (including mild renal impairment)
- Patients with hepatic impairment
- Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus
- Patients with severe infection, severe trauma, or pre- and post-operative patients
- Patients who are malnourished, starved, debilitated, or have pituitary gland insufficiency or adrenal gland insufficiency
- Patients with a history of hypersensitivity to the ingredients in Metact Combination Tablets or biguanides
- Pregnant or potentially pregnant women
Data sourced from ClinicalTrials.gov (NCT02024971). 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.