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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| University of Pennsylvania | OTHER |
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The purpose of this study is to compare the incidence of hospitalization for acute kidney injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.
Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice.
This will be a prospectively-designed database cohort study comparing hospitalizations for acute kidney injury among new initiators of Saxagliptin compared to those who are new initiators of OADs in classes other than DPP4 inhibitors. The study time frame will be from 2009 through 2014.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients exposed to Saxagliptin | |||
| Patients exposed to OAD in classes other than DPP4 inhibitors | OAD - Oral Antidiabetic Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital admission for acute kidney injury | 52 months |
| Measure | Description | Time Frame |
|---|---|---|
| Deaths due to acute kidney injury | 18 months | |
| Deaths due to acute kidney injury | 36 months | |
| Deaths due to acute kidney injury |
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Inclusion Criteria:
Exclusion Criteria:
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This study will carried out using databases containing administrative claims data [ HealthCore Integrated Research DatabaseSM (HIRD) and Medicare in the U.S.] and electronic medical records [ General Practice Research Database (GPRD) and The Health Improvement Network (THIN) in the UK]. The US population includes patients from health plans in the northeast, southeastern, mid-Atlantic, central, mid-western, and western regions (HIRD) as well as US citizens 65 years of age and older (Medicare). The UK population includes patients seeking medical care from general practitioners (GPRD and THIN).
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28878934 | Derived | Lo Re V, Carbonari DM, Saine ME, Newcomb CW, Roy JA, Liu Q, Wu Q, Cardillo S, Haynes K, Kimmel SE, Reese PP, Margolis DJ, Apter AJ, Reddy KR, Hennessy S, Bhullar H, Gallagher AM, Esposito DB, Strom BL. Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes. BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000400. doi: 10.1136/bmjdrc-2017-000400. eCollection 2017. | |
| 25889498 |
| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 54 months |
| Hospitalizations for acute kidney injury and/or death due to acute kidney injury | 18 months |
| Hospitalizations for acute kidney injury and/or death due to acute kidney injury | 36 months |
| Hospitalizations for acute kidney injury and/or death due to acute kidney injury | 54 months |
| Derived |
| Saine ME, Carbonari DM, Newcomb CW, Nezamzadeh MS, Haynes K, Roy JA, Cardillo S, Hennessy S, Holick CN, Esposito DB, Gallagher AM, Bhullar H, Strom BL, Lo Re V 3rd. Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs. BMC Pharmacol Toxicol. 2015 Apr 2;16:8. doi: 10.1186/s40360-015-0007-z. |
| For FDA Safety Alerts and Recalls refer to the following link | View source |
| CSR Synopsis | View source |
| D004700 | Endocrine System Diseases |