Overview

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
2,4-thiazolidinedione
Alogliptin
Criteria
Inclusion Criteria:

- Patients who did not adequately respond to the following treatment • Treatment with
thiazolidinediones in addition to diet therapy and exercise therapy

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