Conditions: Diabetes Mellitus
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 67
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2 diabetic patients with inadequate blood glucose control despite treatment with a rapid-acting insulin secretagogue as well as diet and exercise therapies.

Detailed description:
One alogliptin 25 mg tablet was orally administered once daily before breakfast for up to 52 weeks.

The dose of alogliptin was adjusted according to the severity of the participant's renal dysfunction based on serum creatinine (SCr) levels. Participants with moderate renal dysfunction (SCr, \>1.4 - ≤2.4 mg/dL for men and \>1.2 - ≤ 2.0 mg/dL for women) received alogliptin 12.5 mg tablets.

Arms:
arm 1: Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.

Interventions: intervention 1: Alogliptin intervention 2: Rapid-acting insulin secretagogue
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Either of the following commercially available rapid-acting insulin secretagogues as prescribed by the Investigator: (i) Nateglinide: Dose: 30 mg tablet or 90 mg tablet (ii) Mitiglinide calcium hydrate: Dose: 5 mg tablet or 10 mg tablet

Protocol document: