Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

Takeda

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Alogliptin/Pioglitazone

Study type: Observational

Funder types: Industry

Identifiers

NCT01990300

136-011

JapicCTI-132302 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride

Full description

This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.

The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Enrollment: 3,281 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes mellitus

Exclusion criteria

• Patients meeting any of the following criteria will be excluded:

  1. Patients with current cardiac failure or a past history of cardiac failure
  2. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
  3. Patients with serious hepatic dysfunction
  4. Patients with serious renal dysfunction
  5. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
  6. Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
  7. Pregnant or possibly pregnant women

Trial design

3,281 participants in 1 patient group

Alogliptin/Pioglitazone combination tablets

Description:

Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.

Treatment:

Drug: Alogliptin/Pioglitazone