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Completed

NCT Number: 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)"

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alogliptin

Drug

Alogliptin tablets

Other names: Nesina Tablets

Primary outcomes

  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 outcomes

  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}.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)"

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 20, 2014
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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