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)
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080222558
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
This survey was conducted to evaluate the safety and efficacy of long-term use of Nesina in patients with type 2 diabetes mellitus who had had inadequate response to hypoglycemic agents such as insulin or rapid-acting insulin secretagogues in addition to dietary/exercise therapy. The survey results raised no major concerns about the safety or efficacy of long-term use of Nesina.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 964
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 (RAIS), excluding other types of hypoglycemic agents (e.g., alpha-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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of Participants who had One or More Adverse Reactions<br>Time Frame: Up to Month 12
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from Baseline in Glycosylated Hemoglobin (HbA1c)<br>Time Frame: Baseline, and final assessment point (up to Month 12)<br>efficacy<br>Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)<br>Time Frame: Baseline, and final assessment point (up to Month 12)<br>efficacy<br>Change from Baseline in Laboratory Test Values (Fasting Blood Glucose Level)<br>Time Frame: Baseline, and final assessment point (up to Month 12)<br>efficacy<br>Change from Baseline in Laboratory Test Values (Fasting Insulin Level)<br>Time Frame: Baseline, and final assessment point (up to Month 12)<br>efficacy<br>Change from Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])<br>Time Frame: Baseline, and final assessment point (up to Month 12)<br>efficacy<br>Change from Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-beta])<br>Time Frame: Baseline, and final assessment point (up to Month 12)