Clinical Trial: Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Identification of Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes: An Analysis of Data From the SAVOR Study
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 Summary: Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.
Sponsor: AstraZeneca
Current Primary Outcome: To identify risk factors for lymphopenia, defined as an absolute lymphocyte count < 500 cells/μl, or investigator reported lymphopenia, in the SAVOR study population. [ Time Frame: 60 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia. [ Time Frame: 60 months ]
- To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline. [ Time Frame: 60 months ]
- To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users. [ Time Frame: 60 months ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: August 30, 2010
Date Started: May 2010
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016
