Type 2 diabetes mellitus
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 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. (1) Patients treated with an insulin product for at least 4 weeks (2) Patients who started Actos Tablets for the first time after the start of an insulin product (3) Patients likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets
Exclusion criteria
Exclusion criteria: Patients with contraindications to Actos Tables and insulin products treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions. Primary timeframe 52 weeks from the baseline Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in glycemia-related parameters (fasting blood glucose, glycosylated hemoglobin [HbA1c]), changes in test values (fasting triglycerides, HDL cholesterol, and LDL cholesterol), and changes in the daily dose of insulin product. Secondary timeframe 52 weeks from the baseline Tabulation and analysis of changes in fasting blood glucose, HbA1c, fasting triglycerides, HDL cholesterol, LDL cholesterol, and daily dose of insulin product | — |
Outcome results
None listed