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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
University of Pennsylvania
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01086306
First received: March 11, 2010
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

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
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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

  • To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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

  • To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately) [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Inpatient diagnoses of respiratory tract infections [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Inpatient diagnoses of respiratory tract infections [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Inpatient diagnoses of respiratory tract infections [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 113505
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients exposed to Saxagliptin
Patients exposed to oral antidiabetic drugs (not Saxagliptin)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086306

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01086306     History of Changes
Other Study ID Numbers: CV181-101
Study First Received: March 11, 2010
Last Updated: October 29, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on November 20, 2014