Diabetes type 2
Conditions
Interventions
None listed
Sponsors
J-BRAND Registry Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility will be determined according to the following criteria: (1)Patients who have received a diagnosis of type 2 diabetes and are treated with at least one OHA as per the package insert for the OHA. (2)Patients who have started or added an OHA, or switched* from one OHA to another within the previous 3 months and meet one of the following criteria: Group A: Subjects treated with alogliptin at the time of registration (Alogliptin-treated group) i)Start: Patients who have started alogliptin ii)Add:Patients who have added alogliptin to OHA(s) (excl. DPP-4 inhibitors) currently taken iii)Switch:Patients who have switched a part or all of OHAs currently taken to alogliptin Group B: Subjects not treated with any DPP-4 inhibitor at the time of registration (DPP-4 inhibitor-untreated group) i)Start: Patients who have started an OHA other than DPP-4 inhibitors ii)Add: Patients who have added another OHA, other than DPP-4 inhibitors, to OHA(s) (excl. DPP-4 inhibitors) currently taken iii)Switch:Patients who have switched a part or all of OHAs currently taken to another OHA, other than DPP-4 inhibitors, and are not treated with any DPP-4 inhibitor at the time of registration *:This applies to active pharmaceutical ingredients only. A switch from one OHA (including combination drug products) to another of the same active pharmaceutical ingredient will not be included in the Switch category. (3)Gender and Age: men and women of at least 20 years of age at the time of informed consent (4)Patients willing and able to provide written informed consent prior to participation in this study
Exclusion criteria
Exclusion criteria: Any subject who meets any of the following criteria will not qualify for entry into the study: (1)Patients using parenteral hypoglycemic agents (insulin and glucagon-like peptide-1 [GLP-1] receptor agonists) (2)Patients with severe ketosis, diabetic coma or precoma, severe infection, or serious trauma and patients under the perioperative management (3)Pregnant or lactating women (4)Patients judged by the principal investigator or sub-investigator to be ineligible for participation as study subjects for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, type, and severity of adverse events will be compared between patients treated with alogliptin and patients not treated with any dipeptidyl peptidase-4 (DPP-4) inhibitor at the time of registration (between-group comparison) and among subgroups defined by patient baseline characteristics and by concomitant medications (between- subgroup comparison). All adverse events will be included in the safety evaluation, and major safety endpoints will include hypoglycemia, pancreatitis, skin disorder, infections, and cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy variables will be compared between patients treated with alogliptin and patients not treated with any DPP-4 inhibitor at the time of registration (between-group comparison) and among subgroups defined by patient baseline characteristics and by concomitant medications (between-subgroup comparison). The efficacy variables will include the changes from baseline (= time of registration) in the levels of hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin, and urinary albumin and the new onset and progression of microangiopathy. | — |
Countries
Japan
Contacts
Public ContactDaisaku Iwata
J-BRAND Registry Administrative Office A2 Healthcare Corporation
Outcome results
None listed