Risk of Hospitalized Infections Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatment

NCT ID: NCT01086306

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 113505 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study is to compare the incidence of hospitalizations for infections among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of Oral Anti-Diabetic Drug (OADs) in classes other than DPP4 inhibitors; and to compare the incidence of hospitalizations with infections associated with T-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections [evaluated as a composite outcome]) among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors.

Detailed Description

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT

Study Groups

Patients exposed to Saxagliptin

No interventions assigned to this group

Patients exposed to oral antidiabetic drugs (not Saxagliptin)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Newly prescribed Saxagliptin [or an OAD in a class other than Dipeptidyl peptidase-4 (DPP4) inhibitors]
• Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD

Exclusion Criteria

• Patients identified with a diagnostic code for inpatient diagnostic code for any of the infections of interest within the 180-day baseline period
• Patients with DPP4 inhibitor exposure during the baseline period
• Patients currently using exenatide or insulin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

References

Lo Re V, Carbonari DM, Saine ME, Newcomb CW, Roy JA, Liu Q, Wu Q, Cardillo S, Haynes K, Kimmel SE, Reese PP, Margolis DJ, Apter AJ, Reddy KR, Hennessy S, Bhullar H, Gallagher AM, Esposito DB, Strom BL. Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes. BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000400. doi: 10.1136/bmjdrc-2017-000400. eCollection 2017.

Reference Type: DERIVED

PMID: 28878934 (View on PubMed)

Saine ME, Carbonari DM, Newcomb CW, Nezamzadeh MS, Haynes K, Roy JA, Cardillo S, Hennessy S, Holick CN, Esposito DB, Gallagher AM, Bhullar H, Strom BL, Lo Re V 3rd. Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs. BMC Pharmacol Toxicol. 2015 Apr 2;16:8. doi: 10.1186/s40360-015-0007-z.

Reference Type: DERIVED

PMID: 25889498 (View on PubMed)

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4450&filename=cv181_101.pdf

CSR Synopsis

Other Identifiers

CV181-101

Identifier Type: -

Identifier Source: org_study_id