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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
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12000
Study Start Date: May 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192659

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01192659     History of Changes
Other Study ID Numbers: CV181-102
Study First Received: August 30, 2010
Last Updated: February 17, 2012
Health Authority: United States: Food and Drug Administration
Europe:European Agency for the Evaluation of Medicinal Products
United Kingdom: Medicines and Healtcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
France: Ministry of Health
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Espanol de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Netherlands: The Central Committe on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health and Social Development of the Russian Federation
Argentina: Ministry of Health
Brazil: Ministry of Health
Chile: Instituto de Salud Publica de Chile
Peru: Instituto Nacioanl de Salud
China: State Food and Drug Administration
Taiwan: Department of Health
Thailand: Food and Drug Administration
India: Drugs Controller General of India
Israel: Ministry of Health
Australia: Department of Health and Aging Goods Administration
South Africa: Medicins Control Council
Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 17, 2012