Risk of Cardiovascular Events in Patients With Type 2 Diabetes Initiating Oral Antidiabetic Treatments
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Collaborators:
AstraZeneca
University of Pennsylvania
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01086280
First received: March 11, 2010
Last updated: February 20, 2012
Last verified: February 2012
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Purpose
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 |
|---|
|
Diabetes Mellitus, Type 2 |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Arrhythmia
Diabetes
Diabetes Medicines
Diabetes Type 2
Vascular Diseases
Drug Information available for:
Saxagliptin
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]Myocardial infarction (MI), congestive heart failure (CHF), deep venous thrombosis (DVT), pulmonary embolism (PE)
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
- Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
- Acute MI, acute stroke, death from cardiovascular causes, and coronary and carotid revascularization procedures, evaluated separately and then combined [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
- All-cause death [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
- All-cause death [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
- All-cause death [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 113505 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 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 (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 More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01086280 History of Changes |
| Other Study ID Numbers: | CV181-099 |
| Study First Received: | March 11, 2010 |
| Last Updated: | February 20, 2012 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013