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Trial record 1 of 1 for:    121-015
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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: July 30, 2017
Last verified: July 2017
  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 ]
    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.


Secondary Outcome Measures:
  • 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.


Enrollment: 19192
Actual Study Start Date: August 3, 2011
Study Completion Date: July 31, 2017
Primary Completion Date: July 31, 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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964963     History of Changes
Other Study ID Numbers: 121-015
JapicCTI-132283 ( Registry Identifier: JapicCTI (Japan) )
Study First Received: October 15, 2013
Last Updated: July 30, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017