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Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

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ClinicalTrials.gov Identifier: NCT01945216
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:

The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor.

In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.


Condition or disease Intervention/treatment
Patients With Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution Drug: Alogliptin

Detailed Description:

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.

Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.


Study Type : Observational
Actual Enrollment : 3317 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nesina Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
Study Start Date : July 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alogliptin

Group/Cohort Intervention/treatment
Aloglipin 25mg, tablets, orally, once daily, up to 36 months Drug: Alogliptin
Alogliptin tablets
Other Name: Nesina; SYR-322




Primary Outcome Measures :
  1. Frequency of Adverse event [ 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.

  2. 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes mellitus who have been examined at a medical institution
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:

    1. Diet therapy and exercise therapy alone
    2. In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

Exclusion Criteria:

  • Patients contraindicated for Nesina

    1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
    2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
    3. Patients with a history of hypersensitivity to any ingredient of Nesina

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945216


Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01945216     History of Changes
Other Study ID Numbers: 121-011
JapicCTI-132250 ( Registry Identifier: JapicCTI )
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Takeda:
Drug therapy

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