Type 2 diabetes mellitus
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have not adequately responded to any one of the following therapies: (1) Diet and exercise therapy alone (2) In addition to diet and exercise therapy, use of alpha-glucosidase inhibitor
Exclusion criteria
Exclusion criteria: Patients contraindicated for Nesina (1) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.) (2) Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.) (3) Patients with a history of hypersensitivity to any ingredient of Nesina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of Participants Who Experience at Least One Adverse Events Time Frame: Up to Month 36 efficacy Change from Baseline in Glycosylated Hemoglobin (HbA1c) Time Frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change from Baseline in Fasting Blood Glucose Time Frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) | — |
Countries
Japan
Outcome results
None listed