Replication of the SAVOR-TIMI Diabetes Trial in Healthcare Claims

Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Eligible cohort entry dates: Market availability of saxagliptin in the U.S. started on July 31, 2009 For Marketscan and Medicare: July 31, 2009-Dec 31, 2016 (end of data availability). For Optum: July 31, 2009-Sep 30, 2017 (end of data availability). Inclusion Criteria: * Diagnosed with T2DM based on the current American Diabetes Association guidelines Age ≥40 years Glycated hemoglobin level of ≥6.5% (based on the last measured and documented laboratory measurement in the previous 6 months) High risk for a CV event defined as having either established CV disease and/or multiple risk factors: * History of established cardiovascular disease * Ischemic heart disease, and/or * Peripheral vascular disease (eg, intermittent claudication), and/or * Ischemic stroke * Multiple risk factors for vascular disease - At least 55 years of age (men) or 60 years of age (women), AND at least one of the following additional risk factors * Dyslipidemia (based on the last measured and documented laboratory measurement in the previous 6 months and defined as at least 1 of the following): * High level of low-density lipoprotein cholesterol (LDL-C), defined as N130 mg/dL (N 3.36 mmol/L) regardless of lipid-lowering therapy * Low level of high-density lipoprotein cholesterol (HDL-C), defined as b40 mg/dL (b1.04 mmol/L) for men or b50 mg/dL (b1.30 mmol/L) for women * Hypertension, as confirmed at the enrolment visit * BP N140/N90 mm Hg, or * BP N130/N80 mm Hg on BP-lowering agent * Currently smoking, as confirmed at the enrolment visit Women of childbearing potential must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose. Men participating in the study should also take precautions not to father a childwhile participating in the study and for 4 weeks after intake of the last dose. Provision of informed consent before any study specific procedures Exclusion Criteria: Current or previous (within 6 months) treatment with an incretin-based therapy such as DPP-4 inhibitors and/or GLP-1 mimetics Acute vascular (cardiac or stroke) event \<2 months before randomization Initiation of chronic dialysis and/or renal transplant and/or a serum creatinine \>6.0 mg/dL Pregnant or breastfeeding History of human immunodeficiency virus Patients being treated for severe autoimmune diseases such as lupus Any patient currently receiving long-term (\>30 consecutive days) treatment with an oral steroid Patients with * Body mass index \>50 kg/m2 * Last measured HbA1c ≥12% * Sustained BP \>180/100 mm Hg * LDL-C \>250 mg/dL (\>6.48 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months) regardless of lipid-lowering therapy * Triglycerides \>1,000 mg/dL (N11.3 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6months) * HDL-C b25 mg/dL (\<0.64 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months) * Known liver function tests \>3 times upper limit of normal (ULN) (based on the last measured and documented laboratory measurement in the previous 6 months) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Bristol-- Myers Squibb or representative staff and/or staff at the study site) Previous randomization in the present study Participation in another clinical study with an investigational product and/or intervention within 30 days before visit 1 Individuals at risk for poor protocol or medication compliance