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Completed

NCT Number: NCT01192659

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

    Time frame: 60 months

Secondary outcomes

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

    Time frame: 60 months

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

    Time frame: 60 months

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

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 1, 2010
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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