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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01964963
First received: October 15, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Surveillance
Drug: Alogliptin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nesina Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    The frequency of adverse events by type, seriousness, time to onset, etc. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.

  • Change from Baselin in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and month 36 ] [ Designated as safety issue: No ]
    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 month 36 relative to baseline.


Secondary Outcome Measures:
  • Change from Baselin in Fasting blood glucose [ Time Frame: Baseline and month 36 ] [ Designated as safety issue: No ]
    The change in the value of fasting blood glucose collected at month 36 relative to baseline.


Estimated Enrollment: 20000
Study Start Date: August 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aloglipin
Aloglipin 25 mg, tablets, orally, once daily for up to 12 months
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • Nesina
  • SYR-322

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01964963

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964963     History of Changes
Other Study ID Numbers: 121-015, JapicCTI-132283
Study First Received: October 15, 2013
Last Updated: October 15, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Alogliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014