Oh goody! We are getting the high-risk patients! You know, the ones who tend to have heart attacks! So, good luck trying to show the hypos that didn't happen because of degludec, when drug safety monitoring WILL show the CV events that DID happen, even those that are not the fault of degludec.
Even if CV events are not the fault of degludec, when your drug is used in a patient pool of high-risk patients (elderly diabetics, Type 1's with erratic eating/exercise habits, etc.), there will be trouble and degludec will be accused, no matter how unfairly. Usage in high-risk populations in Europe will generate a sizable number of CV events and that will NOT help degludec in the eyes of US regulatory folks.
That aside, what percentage of a U.S. doctor's practice is comprised of the patients you describe as typical degludec users? 5%? 10%? Ask your PCP docs you call on now to tell you the percentage of patients in their practice who do shift work, have repeated hospitalizations for hypos or are in a SNF/LTC setting. You obviously can't mention degludec, but do some blinded market research. Post back here with your results. I'm betting 10% max of a doctor's patients would be a degludec patient.
What you've got is a niche product with a premium price, that will peak at 5-10% market share. Sounds like "Son of Levemir" to me....