Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes

Identification of Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes: An Analysis of Data From the SAVOR Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01192659

Enrollment

16492

Registered

2010-09-01

Start date

2010-05-31

Completion date

2015-12-31

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Secondary

Measure	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
To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users.	60 months

Outcome results