Risk of Cardiovascular Events in Patients With Type 2 Diabetes Initiating Oral Antidiabetic Treatments

• ClinicalTrials.gov Identifier: NCT01086280
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: September 20, 2016
• Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb; University of Pennsylvania
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief Summary:

The purpose of this study is to compare the incidence of major cardiovascular events among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of oral anti-diabetic drugs (OADs)in classes other than Dipeptidyl peptidase IV (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 Major Cardiovascular Events Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments
• Study Start Date: January 2010
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Major cardiovascular events defined as a composite of acute MI, stroke or death due to acute MI, stroke, CHF, dysrhythmia, sudden death, or coronary revascularization. Alternative outcomes include DVT, PE, and arterial vascular disease [ Time Frame: 18-months ]
   Myocardial infarction (MI), congestive heart failure (CHF), deep venous thrombosis (DVT), pulmonary embolism (PE)
2. Major cardiovascular events defined as a composite of acute MI, stroke or death due to acute MI, stroke, CHF, dysrhythmia, sudden death, or coronary revascularization. Alternative outcomes include DVT, PE, and arterial vascular disease [ Time Frame: 36-months ]
3. Major cardiovascular events defined as a composite of acute MI, stroke or death due to acute MI, stroke, CHF, dysrhythmia, sudden death, or coronary revascularization. Alternative outcomes include DVT, PE, and arterial vascular disease [ Time Frame: 54-months ]

Secondary Outcome Measures :

1. Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined [ Time Frame: 18-months ]
2. Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined [ Time Frame: 36-months ]
3. Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined [ Time Frame: 54-months ]
4. All-cause death [ Time Frame: 18-months ]
5. All-cause death [ Time Frame: 36-months ]
6. All-cause death [ Time Frame: 54-months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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 (HIRD and Medicare in the U.S.) and electronic medical records (GPRD and 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 DPP4 inhibitors
• Enrolled in the respective database for at least 180 days prior to the first prescription for Saxagliptin or other OAD in a class other than DPP4 inhibitors

Exclusion Criteria:

• Patients identified with a diagnostic code for any of the cardiovascular outcomes of interest within the 180-day baseline period
• Patients prescribed a DPP4 inhibitor during the baseline period

Contacts and Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

University of Pennsylvania

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

Investigator Inquiry form 

CSR Synopsis 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01086280
• Other Study ID Numbers: CV181-099
• First Posted: March 15, 2010
• 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