N/A
N=964
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
Bottom Line
View on ClinicalTrials.gov: NCT02221284 ↗Enrolled (actual)
964
Serious AEs
0.3%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of Participants Who Had One or More Adverse Reactions — 5.41; 1.20; 0.98; 0.00 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Alogliptin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Reactions |
5.41; 1.20; 0.98; 0.00 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.66; -0.49; -0.60 | — |
| SECONDARY Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%) |
161; 87; 55; 22; 10; 7 | — |
| SECONDARY Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level) |
-16.4; -32.0; -18.7 | — |
| SECONDARY Change From Baseline in Laboratory Test Values (Fasting Insulin Level) |
-3.08; 2.26; 0.40 | — |
| SECONDARY Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R]) |
-2.58; -0.25; 0.00 | — |
| SECONDARY Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β]) |
12.32; 33.38; 15.40 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT02221284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.