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)"

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02221284
• Date of registration: 18/08/2014
• Prospective Registration: No
• Primary sponsor: Takeda
• Public title: 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)"
• Scientific 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)"
• Date of first enrolment: June 30, 2014
• Target sample size: 964
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02221284
• Study type: Observational

Countries of recruitment

Japan

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion 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., 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Alogliptin

Primary Outcome(s)

Percentage of Participants Who Had One or More Adverse Reactions [Time Frame: Up to Month 12]

Secondary Outcome(s)

Change From Baseline in Laboratory Test Values (Fasting Insulin Level) [Time Frame: Baseline, and final assessment point (up to Month 12)]

Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%) [Time Frame: Baseline, and final assessment point (up to Month 12)]

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

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

Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level) [Time Frame: Baseline, and final assessment point (up to Month 12)]

Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-ß]) [Time Frame: Baseline, and final assessment point (up to Month 12)]

Secondary ID(s)

121-016

JapicCTI-142609

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02221284