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

November 30, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

16492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enrolled in the Saxagliptin Assessment of Vascular Outcomes Recorded in Diabetes Mellitus study, which is a randomized, placebo-controlled phase 4 study of cardiovascular outcomes). 12,000 patients with type 2 diabetes and either a history of a cardiovascular event or multiple risk factors for vascular disease. Patients will be distributed as follows: at least 30% in North America, approximately 30% in Europe, and the remainder in South America, Asia, Australia, and South Africa.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 60 months
60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia.
Time Frame: 60 months
60 months
To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline.
Time Frame: 60 months
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
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV181-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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