Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution Clinical Trial
Official title:
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
| Verified date | November 2019 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to determine the safety and efficacy of long-term treatment with
alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to
diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy,
and α-glucosidase inhibitor.
In addition, examining the safety and efficacy of alogliptin in patients with renal
impairment, information on the appropriate dosage of alogliptin according to the severity of
impaired renal function should be collected.
| Status | Completed |
| Enrollment | 3317 |
| Est. completion date | October 31, 2015 |
| Est. primary completion date | October 31, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies: 1. Diet therapy and exercise therapy alone 2. In addition to diet therapy and exercise therapy, use of a-glucosidase inhibitor 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Events | Up to Month 36 | ||
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at month 36 relative to baseline. | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) | |
| Secondary | Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose collected at month 36 relative to baseline. | Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) |