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

NCT01192659 | Completed

• 1 other identifier: CV181-102
• Study Type: observational
• Target: 16,492
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

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.

  60 months

Secondary Outcomes (3)

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

  60 months

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

  60 months

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

  60 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Related Links

• For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
• CSR Synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 1, 2016

Record last verified: 2016-11