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

AstraZeneca

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Industry

Identifiers

NCT01192659

CV181-102

Details and patient eligibility

About

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.

Full description

Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.

Enrollment: 16,492 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

16,492 participants in 2 patient groups

Patients treated with saxagliptin or placebo

Description:

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

Description:

Patients currently or previously on (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics are excluded.