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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01964976

Surveillance

COMPLETED

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

NCT01945242

Type 2 Diabetes Melitus

COMPLETED

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

NCT01945216

Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution

COMPLETED

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)"

NCT02221284

Type 2 Diabetes Mellitus

COMPLETED

Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

NCT01964963

Type 2 Diabetes Mellitus

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting.

Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surveillance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alogliptin

All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with Sulfonylurea (SU) or without SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy

Exclusion Criteria

1. Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate).
2. Participants with severe infection, pre- or post-operative participants, or participants with serious traumatic injury (blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate).
3. Participants with a history of hypersensitivity to any ingredient of Nesina.

Eligible Sex

ALL

Accepts Healthy Volunteers

No