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)"
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)"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 964
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Reactions
timeFrame: Up to Month 12
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, and final assessment point (up to Month 12)
measure: Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)
timeFrame: Baseline, and final assessment point (up to Month 12)
measure: Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)
timeFrame: Baseline, and final assessment point (up to Month 12)
measure: Change From Baseline in Laboratory Test Values (Fasting Insulin Level)
timeFrame: Baseline, and final assessment point (up to Month 12)
measure: Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])
timeFrame: Baseline, and final assessment point (up to Month 12)
measure: Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])
timeFrame: Baseline, and final assessment point (up to Month 12)
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: