Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RRA-15322 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i) versus new use of various other antihyperglycemic agents (AHAs), combined as one group.
This study will be an overall retrospective, observational, new-user cohort study using 4 large administrative claims databases in the US. Participants diagnosed with T2DM and initiated on SGLT2i or other AHAs (metformin, sulfonylureas (SU), thiazolidinediones (TZDs), DPP-4 inhibitors (DPP4i), GLP-1 agonists, insulin, and other AHAs) between April 1, 2013 and the end of claims data availability will be included in the study and will be estimated for incidence rates of DKA in the different AHA new-user groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Cohort 1 included participants who were exposed to sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin and empagliflozin). |
| |
| Cohort 2 | Cohort 2 included participants who were exposed to other non-SGLT2 antihyperglycemic agents (AHA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Drug | This is an observational study and participants did not receive any intervention in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA) | Day 1 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Participants who receive diagnosis of type1 diabetes mellitus (T1DM) and/or secondary diabetes mellitus (SDM) any time after index date.
Not provided
Not provided
Not provided
Participants diagnosed with type 2 diabetes mellitus (T2DM) and initiated on sodium-glucose co-transporter 2 inhibitors (SGLT2i) or other Antihyperglycemic Agents (AHAs) were observed.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trials | Janssen Research & Development, LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided