Replication of the DECLARE Diabetes Trial in Healthcare Claims

Exclusion Criteria

• •1. Use of the following excluded medications:
• •* Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for 2 years or more at any time
• •* Current or recent (within 12 months) treatment with rosiglitazone
• •* Previous treatment with any SGLT2 inhibitor
• •* Any patient currently receiving chronic (\>30 consecutive days) treatment with an oral steroid at a dose equivalent to oral prednisolone ≥10 mg (e.g., betamethasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) per day
• •2. Acute cardiovascular event \[e.g., acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, any revascularization, decompensated HF, sustained tachycardia \<8 weeks prior to randomization. Patients with acute cardiovascular events can be enrolled in the run-in period as long as randomization does not occur within 8 weeks of the event.
• •3. Systolic BP \>180 or diastolic BP \>100 mmHg at randomization
• •4. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
• •5. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
• •6. History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
• •7. Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
• •8. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including but not limited to cardiovascular (NYHA class IV CHF, recurrent ventricular arrhythmias) or non-cardiovascular disease (e.g., active malignancy with the exception of basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease) and/or a likely fatal outcome within 5 years
• •9. Pregnant or breast-feeding patients
• •10. Involvement in the planning and/or conduct of the study or other dapagliflozin studies (applies to AZ, BMS, Hadassah and Thrombolysis in Myocardial Infarction \[TIMI\] or representative staff and/or staff at the study site)
• •11. Previous randomization in the present study
• •12. Active participation in another clinical study with IP and/or investigational device
• •13. Individuals at risk for poor protocol or medication compliance during run-in period (reasonable compliance defined as 80 - 120%, unless a reason for non-compliance is judged acceptable by the Investigator). If for any reason, the Investigator believes that the patient will not tolerate or be compliant with IP or study procedures, the patient should not be randomized and considered a run-in failure. Patients will be excluded during run-in and should not be randomized if the following are observed from laboratory or observation during enrollment and run-in assessments:
• •14. HbA1c ≥12% or HbA1c\<6.5%
• •15. AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN
• •16. CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
• •18. Any reason the Investigator believes the patient is not likely to be compliant with the study medication and protocol.