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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)"

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ClinicalTrials.gov Identifier: NCT02221284
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:

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.


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

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.


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Study Type : Observational
Actual Enrollment : 964 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alogliptin (Nesina) Tablets Specified Drug-use Survey "Type 2 Diabetes Mellitus: Combination Therapy With Hypoglycemic Drug (Insulin Preparation or Rapid-acting Insulin Secretagogues, Etc)"
Actual Study Start Date : June 30, 2014
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alogliptin

Group/Cohort Intervention/treatment
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.
Drug: Alogliptin
Alogliptin tablets
Other Name: Nesina Tablets




Primary Outcome Measures :
  1. Percentage of Participants Who Had One or More Adverse Reactions [ Time Frame: Up to Month 12 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, and final assessment point (up to Month 12) ]
    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.

  2. Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%) [ Time Frame: Baseline, and final assessment point (up to Month 12) ]
    The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study.

  3. Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level) [ Time Frame: Baseline, and final assessment point (up to Month 12) ]
    The reported data were change from baseline in fasting blood glucose level.

  4. Change From Baseline in Laboratory Test Values (Fasting Insulin Level) [ Time Frame: Baseline, and final assessment point (up to Month 12) ]
    The reported data were change from baseline in fasting insulin level.

  5. Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R]) [ Time Frame: Baseline, and final assessment point (up to Month 12) ]
    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.

  6. 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) ]
    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}.



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
Type 2 diabetes mellitus
Criteria

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

  1. 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.]
  2. 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.]
  3. Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets

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): NCT02221284


Locations
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Japan
Osaka, 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] June 2, 2017
Statistical Analysis Plan  [PDF] April 11, 2018


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02221284     History of Changes
Other Study ID Numbers: 121-016
JapicCTI-142609 ( Registry Identifier: JapicCTI )
First Posted: August 20, 2014    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 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
Keywords provided by Takeda:
Pharmacological therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Alogliptin
Insulin, Short-Acting
Hypoglycemic Agents
Secretagogues
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