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Completed

NCT Number: NCT01964963

Alogliptin 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Alogliptin

Drug

Alogliptin tablets

Other names: Nesina, SYR-322

Primary outcomes

  1. Percentage of Participants Who Had One or More Adverse Events

    Time frame: Up to Month 36

  2. Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline, and final assessment point (up to Month 36)

    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.

Secondary outcomes

  1. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, and final assessment point (up to Month 36)

    The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2013
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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