Overview

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

Status:
Completed

Trial end date:
0000-00-00

Target enrollment:
1096

Participant gender:
Both

Summary

To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Takeda

Treatments:

Alogliptin

Last Updated:

2015-01-23

Criteria

Inclusion Criteria:

- Patients who did not adequately respond to the following treatment • Treatment with
biguanides 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