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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to identify risk factors for low lymphocyte count among patients with type 2 diabetes who are treated with oral antidiabetic drugs.
Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with saxagliptin or placebo | Patients will be treated with saxagliptin or placebo, on top of whatever baseline treatment for diabetes the patient is already receiving. | ||
| Patients currently or previously on treatment | Patients currently or previously on (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics are excluded. |
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| Measure | Description | Time Frame |
|---|---|---|
| To identify risk factors for lymphopenia, defined as an absolute lymphocyte count < 500 cells/μl, or investigator reported lymphopenia, in the SAVOR study population. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia. | 60 months | |
| To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline. | 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled in the Saxagliptin Assessment of Vascular Outcomes Recorded in Diabetes Mellitus study, which is a randomized, placebo-controlled phase 4 study of cardiovascular outcomes). 12,000 patients with type 2 diabetes and either a history of a cardiovascular event or multiple risk factors for vascular disease. Patients will be distributed as follows: at least 30% in North America, approximately 30% in Europe, and the remainder in South America, Asia, Australia, and South Africa.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm | View source |
| CSR Synopsis | 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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| To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users. | 60 months |
| D004700 | Endocrine System Diseases |