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

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

The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Alogliptin

Detailed Description

This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.

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

• Study Type: Observational
• Enrollment (Actual): 19192

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with mild type 2 diabetes mellitus who have been examined at a medical institution

Description

Inclusion Criteria:

-Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

Exclusion Criteria:

-Patients contraindicated for alogliptin.

1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
3. Patients with a history of hypersensitivity to any ingredient of alogliptin.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alogliptin; Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.	Drug: Alogliptin; Alogliptin tablets; Other Names: SYR-322; Nesina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Had One or More Adverse Events		Up to Month 36
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 36) relative to baseline.	Baseline, and final assessment point (up to Month 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Blood Glucose	The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.	Baseline, and final assessment point (up to Month 36)

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2011
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Alogliptin
• Other Study ID Numbers: 121-015; JapicCTI-132283 (Registry Identifier: JapicCTI (Japan))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No