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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964963
• Other study ID #: 121-015
• Secondary ID: JapicCTI-132283
• Status: Completed
• Start date: August 3, 2011
• Est. completion date: July 31, 2017

Study information

• Verified date: November 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19192
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Alogliptin
Alogliptin tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Had One or More Adverse Events		Up to Month 36
Primary	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	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)