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

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ClinicalTrials.gov Identifier: NCT01086306
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : September 20, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Diabetes Mellitus, Type 2

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

Study Design

Study Type : Observational
Actual Enrollment : 113505 participants
Observational Model: Cohort
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 Start Date : January 2010
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients exposed to Saxagliptin
Patients exposed to oral antidiabetic drugs (not Saxagliptin)


Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: 18 months ]
  2. 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 [ Time Frame: 36 months ]
  3. 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 [ Time Frame: 54 months ]
  4. To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction [ Time Frame: 18 months ]
    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

  5. To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction [ Time Frame: 36 months ]
    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

  6. To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction [ Time Frame: 54 months ]
    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


Secondary Outcome Measures :
  1. A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies [ Time Frame: 18 months ]
  2. A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies [ Time Frame: 36 months ]
  3. A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies [ Time Frame: 54 months ]
  4. Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately) [ Time Frame: 18 months ]
  5. Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately) [ Time Frame: 36 months ]
  6. Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately) [ Time Frame: 54 months ]
  7. Inpatient diagnoses of respiratory tract infections [ Time Frame: 18 months ]
  8. Inpatient diagnoses of respiratory tract infections [ Time Frame: 36 months ]
  9. Inpatient diagnoses of respiratory tract infections [ Time Frame: 54 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086306


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01086306     History of Changes
Other Study ID Numbers: CV181-101
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Hypoglycemic Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action