- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02221284
Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)"
Alogliptin (Nesina) Tablets Specified Drug-use Survey "Type 2 Diabetes Mellitus: Combination Therapy With Hypoglycemic Drug (Insulin Preparation or Rapid-acting Insulin Secretagogues, Etc)"
The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.
* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.
Study Overview
Detailed Description
This survey was designed to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.
For adults, 25 mg of alogliptin is usually administered orally once daily.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Osaka, Japan
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Tokyo, Japan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-Type 2 diabetic patients meeting the following criteria are included in this survey:
Patients who have had an inadequate response to the following medications/therapies:
• Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise therapy
* For use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing.
Exclusion Criteria:
-Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for alogliptin tablets
- Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus [Quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of alogliptin tablets is not appropriate.]
- Those with severe infections, before or after surgery, or with serious trauma [Controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of alogliptin tablets is not appropriate.]
- Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Alogliptin
Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.
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Alogliptin tablets
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Had One or More Adverse Reactions
Time Frame: Up to Month 12
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Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
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Up to Month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline, and final assessment point (up to Month 12)
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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 12) relative to baseline.
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Baseline, and final assessment point (up to Month 12)
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Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)
Time Frame: Baseline, and final assessment point (up to Month 12)
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The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study.
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Baseline, and final assessment point (up to Month 12)
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Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)
Time Frame: Baseline, and final assessment point (up to Month 12)
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The reported data were change from baseline in fasting blood glucose level.
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Baseline, and final assessment point (up to Month 12)
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Change From Baseline in Laboratory Test Values (Fasting Insulin Level)
Time Frame: Baseline, and final assessment point (up to Month 12)
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The reported data were change from baseline in fasting insulin level.
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Baseline, and final assessment point (up to Month 12)
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Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])
Time Frame: Baseline, and final assessment point (up to Month 12)
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The reported data were change from baseline in HOMA-R.
HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405).
A higher score indicates higher insulin resistance.
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Baseline, and final assessment point (up to Month 12)
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Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])
Time Frame: Baseline, and final assessment point (up to Month 12)
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The reported data were change from baseline in HOMA-β.
HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.
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Baseline, and final assessment point (up to Month 12)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Alogliptin
Other Study ID Numbers
- 121-016
- JapicCTI-142609 (Registry Identifier: JapicCTI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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