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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01192659
Collaborator
Bristol-Myers Squibb (Industry)
16,492
Enrollment
67
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    16492 participants
    Time Perspective:
    Prospective
    Official Title:
    Identification of Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes: An Analysis of Data From the SAVOR Study
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia. [60 months]

    2. To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline. [60 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca
    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01192659
    Other Study ID Numbers:
    • CV181-102
    First Posted:
    Sep 1, 2010
    Last Update Posted:
    Dec 1, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Lymphopenia
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Dec 1, 2016