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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192659
• Other study ID #: CV181-102
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: November 30, 2016
• Start date: May 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEurope:European Agency for the Evaluation of Medicinal ProductsUnited Kingdom: Medicines and Healtcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlFrance: Ministry of HealthGermany: Ethics CommissionHungary: National Institute of PharmacyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Agencia Espanol de Medicamentos y Productos SanitariosSweden: Medical Products AgencyNetherlands: The Central Committe on Research Involving Human Subjects (CCMO)Russia: Ministry of Health of the Russian FederationArgentina: Ministry of HealthBrazil: Ministry of HealthChile: Instituto de Salud Pública de ChilePeru: Instituto Nacioanl de SaludChina: Food and Drug AdministrationTaiwan: Department of HealthThailand: Food and Drug AdministrationIndia: Drugs Controller General of IndiaIsrael: Ministry of HealthAustralia: Department of Health and Aging Goods AdministrationSouth Africa: Medicins Control CouncilMexico: Federal Commission for Protection Against Health Risks
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16492
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Lymphopenia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia.		60 months	Yes
Secondary	To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline.		60 months	Yes
Secondary	To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users.		60 months	Yes

External Links

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