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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

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Alogliptin

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.


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Study Type : Observational
Actual Enrollment : 19192 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
Actual Study Start Date : August 3, 2011
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alogliptin

Group/Cohort Intervention/treatment
Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • Nesina
  • SYR-322




Primary Outcome Measures :
  1. Percentage of Participants Who Had One or More Adverse Events [ Time Frame: Up to Month 36 ]
  2. 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.


Secondary Outcome Measures :
  1. 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.



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:   Probability Sample
Study Population
Patients with mild type 2 diabetes mellitus who have been examined at a medical institution
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.

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): NCT01964963


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] March 2, 2017
Statistical Analysis Plan  [PDF] December 18, 2017


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964963     History of Changes
Other Study ID Numbers: 121-015
JapicCTI-132283 ( Registry Identifier: JapicCTI (Japan) )
First Posted: October 17, 2013    Key Record Dates
Results First Posted: May 9, 2019
Last Update Posted: May 9, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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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