Clinical trial NCT01086306: Risk of Hospitalized Infections Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatment
Official title: Comparison of Risk of Hospitalization for Infections Between Patients With Type 2 Diabetes Exposed to Saxagliptin and Those Exposed to Other Oral Anti-Diabetic Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: University of Pennsylvania
First posted: 2010-03-15
Enrollment: 113505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be carried out using databases containing administrative claims data \[HealthCore Integrated Research Database (HIRD) and Medicare in the U.S.\] and electronic medical records \[General Practice Research Database (GPRD) and The Health Improvement Network (THIN) in the UK\]. The US population includes patients from health plans in the northeast, southeastern, mid-Atlantic, central, mid-western, and western regions (HIRD) as well as US citizens 65 years of age and older (Medicare). The UK population includes patients seeking medical care from general practitioners (GPRD and THIN)

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

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

Primary outcomes:
measure: 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 antidiabetic drug (OADs) in classes other than DPP4 inhibitors
timeFrame: 18 months
measure: 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 antidiabetic drug (OADs) in classes other than DPP4 inhibitors
timeFrame: 36 months
measure: 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 antidiabetic drug (OADs) in classes other than DPP4 inhibitors
timeFrame: 54 months
measure: To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction
timeFrame: 18 months
measure: To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction
timeFrame: 36 months
measure: To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction
timeFrame: 54 months
Secondary outcomes:
measure: A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies
timeFrame: 18 months
measure: A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies
timeFrame: 36 months
measure: A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies
timeFrame: 54 months
measure: Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)
timeFrame: 18 months
measure: Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)
timeFrame: 36 months
measure: Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)
timeFrame: 54 months
measure: Inpatient diagnoses of respiratory tract infections
timeFrame: 18 months
measure: Inpatient diagnoses of respiratory tract infections
timeFrame: 36 months
measure: Inpatient diagnoses of respiratory tract infections
timeFrame: 54 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.