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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
Last Update Posted : July 5, 2017
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 in daily medical practice.

* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for Nesina 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 in daily medical practice.

For adults, 25 mg of alogliptin is usually administered orally once daily.


Study Type : Observational
Actual Enrollment : 965 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Oral administration of one tablet (25 mg) of alogliptin
Oral administration of one tablet (25 mg) of alogliptin once daily
Drug: Alogliptin
Alogliptin tablets
Other Name: Nesina Tablets




Primary Outcome Measures :
  1. Frequency of adverse drug reactions [ Time Frame: For 12 months ]
    Adverse events observed during the observation period will be collected by symptom. For adverse drug reactions, frequencies will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of alogliptin whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with alogliptin are defined as adverse drug reactions.


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: From baseline to 12 months of treatment ]
    HbA1c test values and the corresponding change from baseline at each testing time point (i.e., test value at each testing time point − test value at baseline) will be tabulated. In addition, the objective glycemic control achievement rate at each testing time point will be tabulated.

  2. Changes in laboratory test values [ Time Frame: From baseline to 12 months of treatment ]
    Test values (fasting blood glucose level, fasting insulin level, homeostasis model assessment ratio [HOMA-R], and homeostasis model assessment of β-cell function [HOMA-β]) and the corresponding changes from baseline at each testing time point (i.e., test value at each testing time point − test value at baseline) will be tabulated.



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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
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 Nesina 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 Nesina 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 Nesina 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 Nesina Tablets is not appropriate.]
  3. Those with a history of hypersensitivity to any of the ingredients of Nesina 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
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda

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
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Alogliptin
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Insulin, Short-Acting
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