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) "

Nesina Tablets specified drug-use survey "Type 2 diabetes mellitus: Combination therapy with hypoglycemic drug (insulin preparation or rapid-acting insulin secretagogues, etc)"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080222558

Enrollment

964

Registered

2014-07-14

Start date

2014-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

investigational material(s) Generic name etc : Nesina Tablets (alogliptin) INN of investigational material : Alogliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration fo

Eligibility

Sex/Gender

All

Inclusion criteria

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 (RAIS), excluding other types of hypoglycemic agents (e.g., alpha-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise therapy * For use of Nesina Tablets in combination with these agents, a specified drug-use survey is currently ongoing.

Exclusion criteria

Exclusion criteria: Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for Nesina 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 Nesina 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 Nesina Tablets is not appropriate.] (3) Those with a history of hypersensitivity to any of the ingredients of Nesina Tablets

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants who had One or More Adverse Reactions Time Frame: Up to Month 12	—

Secondary

Measure	Time frame
efficacy Change from Baseline in Glycosylated Hemoglobin (HbA1c) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Fasting Blood Glucose Level) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Fasting Insulin Level) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R]) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-beta]) Time Frame: Baseline, and final assessment point (up to Month 12)	—

Measure

Time frame

efficacy Change from Baseline in Glycosylated Hemoglobin (HbA1c) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Fasting Blood Glucose Level) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Fasting Insulin Level) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R]) Time Frame: Baseline, and final assessment point (up to Month 12) efficacy Change from Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-beta]) Time Frame: Baseline, and final assessment point (up to Month 12)

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026