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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01192659
First received: August 30, 2010
Last updated: February 17, 2012
Last verified: February 2012
History of Changes

August 30, 2010
February 17, 2012
May 2010
May 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01192659 on ClinicalTrials.gov Archive Site
  • To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes
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.

Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
Diabetes Mellitus, Type 2
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12000
June 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01192659
CV181-102
No
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP