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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01964963
First received: October 15, 2013
Last updated: May 10, 2017
Last verified: May 2017

October 15, 2013
May 10, 2017
August 3, 2011
July 31, 2016   (Final data collection date for primary outcome measure)
  • Frequency of Adverse events [ Time Frame: 36 months ]
    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 ]
    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.
Same as current
Complete list of historical versions of study NCT01964963 on ClinicalTrials.gov Archive Site
Change from Baselin in Fasting blood glucose [ Time Frame: Baseline and month 36 ]
The change in the value of fasting blood glucose collected at month 36 relative to baseline.
Same as current
Not Provided
Not Provided
 
Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with mild type 2 diabetes mellitus who have been examined at a medical institution
Surveillance
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • Nesina
  • SYR-322
Aloglipin
Aloglipin 25 mg, tablets, orally, once daily for up to 12 months
Intervention: Drug: Alogliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19192
July 31, 2016
July 31, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01964963
121-015
JapicCTI-132283 ( Registry Identifier: JapicCTI (Japan) )
No
Not Provided
Not Provided
Not Provided
Takeda
Takeda
Not Provided
Study Chair: Postmarketing Group Manager Takeda
Takeda
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP