Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT01192659
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16492
Inclusion Criteria
- Enrolled in SAVOR
- Diagnosed with T2DM
- Baseline HbA1c ≥6.5% (based on the last measured and documented laboratory measurement within 6 months)
- Age 40 or older
- High risk for a cardiovascular event
Exclusion Criteria
- Not enrolled in SAVOR
- Current or previous treatment with DPP4 inhibitors and/or GLP-1 or incretin mimetics.
- Acute vascular event
- Pregnancy
- HIV/AIDS
- Severe autoimmune disease
- Current chronic steroid use
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users. 60 months To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline. 60 months To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia. 60 months