Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)"

Takeda964 enrolled

Overview

The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)\* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care. \* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.

This survey was designed to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care. For adults, 25 mg of alogliptin is usually administered orally once daily.

Study Type

OBSERVATIONAL

Enrollment

964

Conditions

Type 2 Diabetes Mellitus

Interventions

Alogliptin

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: -Type 2 diabetic patients meeting the following criteria are included in this survey: Patients who have had an inadequate response to the following medications/therapies: • Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)\*, in addition to dietary/exercise therapy \* For use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing. Exclusion Criteria: -Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for alogliptin tablets 1. Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus \[Quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of alogliptin tablets is not appropriate.\] 2. Those with severe infections, before or after surgery, or with serious trauma \[Controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of alogliptin tablets is not appropriate.\] 3. Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets

Outcomes

Primary Outcomes

Percentage of Participants Who Had One or More Adverse Reactions

Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Time frame: Up to Month 12

Secondary Outcomes

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 final assessment point (up to Month 12) relative to baseline.