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

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ClinicalTrials.gov Identifier: NCT01964963
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date October 15, 2013
First Posted Date October 17, 2013
Results First Submitted Date July 27, 2018
Results First Posted Date May 9, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date August 3, 2011
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 7, 2019)
  • Percentage of Participants Who Had One or More Adverse Events [ Time Frame: Up to Month 36 ]
  • 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.
Original Primary Outcome Measures
 (submitted: October 15, 2013)
  • 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.
Change History Complete list of historical versions of study NCT01964963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 7, 2019)
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.
Original Secondary Outcome Measures
 (submitted: October 15, 2013)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
Official Title Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
Brief 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with mild type 2 diabetes mellitus who have been examined at a medical institution
Condition Type 2 Diabetes Mellitus
Intervention Drug: Alogliptin
Alogliptin tablets
Other Names:
  • Nesina
  • SYR-322
Study Groups/Cohorts Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
Intervention: Drug: Alogliptin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 29, 2014)
19192
Original Estimated Enrollment
 (submitted: October 15, 2013)
20000
Actual Study Completion Date July 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01964963
Other Study ID Numbers 121-015
JapicCTI-132283 ( Registry Identifier: JapicCTI (Japan) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date February 2019