Overview

This trial is active, not recruiting.

Condition surveillance
Treatment alogliptin
Sponsor Takeda
Start date August 2011
End date January 2017
Trial size 19192 participants
Trial identifier NCT01964963, 121-015, JapicCTI-132283

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Aloglipin 25 mg, tablets, orally, once daily for up to 12 months
alogliptin Nesina
Alogliptin tablets

Primary Outcomes

Measure
Frequency of Adverse events
time frame: 36 months
Change from Baselin in Glycosylated Hemoglobin (HbA1c)
time frame: Baseline and month 36

Secondary Outcomes

Measure
Change from Baselin in Fasting blood glucose
time frame: Baseline and month 36

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients with HbA1c (JDS value) ≤7.0% at the time of enrolment (within 3 months before initiation of Nesina therapy), regardless of the use of antidiabetic medication. Exclusion Criteria: - Patients contraindicated for Nesina 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 Nesina.

Additional Information

Official title Nesina Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Takeda.