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)"

Type 2 Diabetes Mellitus Clinical Trial

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)"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221284
• Other study ID #: 121-016
• Secondary ID: JapicCTI-142609
• Status: Completed
• Start date: June 30, 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 964
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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., a-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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Alogliptin
Alogliptin tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Had One or More Adverse Reactions	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.	Up to Month 12
Secondary	Change From Baseline in Glycosylated Hemoglobin (HbA1c)	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.	Baseline, and final assessment point (up to Month 12)
Secondary	Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)	The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study.	Baseline, and final assessment point (up to Month 12)
Secondary	Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)	The reported data were change from baseline in fasting blood glucose level.	Baseline, and final assessment point (up to Month 12)
Secondary	Change From Baseline in Laboratory Test Values (Fasting Insulin Level)	The reported data were change from baseline in fasting insulin level.	Baseline, and final assessment point (up to Month 12)
Secondary	Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])	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.	Baseline, and final assessment point (up to Month 12)
Secondary	Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-ß])	The reported data were change from baseline in HOMA-ß. HOMA-ß measures as following; HOMA-ß = fasting insulin (µU/mL) ×360/{fasting glucose (mg/dL) - 63}.	Baseline, and final assessment point (up to Month 12)