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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01192659
First received: August 30, 2010
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
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
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: 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

Further study details as provided by AstraZeneca:

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

Enrollment: 16492
Study Start Date: May 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192659

Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01192659     History of Changes
Other Study ID Numbers: CV181-102
Study First Received: August 30, 2010
Last Updated: November 30, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Lymphopenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on March 27, 2017