MedDataX Logo

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

NCT ID: NCT01192659

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

16492 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

Access external resources that provide additional context or updates about the study.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

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

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4124&filename=CV181-102_Final_Study_Report%20_Redacted.pdf

CSR Synopsis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CV181-102

Identifier Type: -

Identifier Source: org_study_id