Type 2 diabetes mellitus responded inadequately to treatment with biguanides
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy 2. Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment 3. Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment
Exclusion criteria
Exclusion criteria: 1. Patients who have received Actos Tablets within the past 3 months. 2. Patients who started treatment with biguanides and Actos Tablets simultaneously 3. Patients who discontinued biguanides and switched to Actos Tablets treatment. 4. Patients who received additional biguanides after the start of Actos Tablets treatment 5. Patients with contraindications to Actos Tablets treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events Primary timeframe 12 months The frequency of adverse events by type, seriousness and time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in diabetes-related test values Secondary timeframe From the start to 12 months of treatment Calculation of summary statistics for HbA1c, fasting blood glucose, fasting immunoreactive insulin (IRI), and body weight. Calculation of homeostasis model assessment ratio (HOMA-R) and tabulation of summary statistics. | — |
Outcome results
None listed