Japan-Based clinical ReseArch Network for Diabetes Registry
Not Applicable
- Conditions
- Diabetes type 2
- Registration Number
- JPRN-UMIN000007976
- Lead Sponsor
- J-BRAND Registry Study Group
- Brief Summary
The same level of safety and efficacy was shown between groups A and B, confirming the usefulness of alogliptin for the treatment of type 2 diabetes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5208
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.