EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) was the first major trial published evaluating SGLT2-i use for reduction of MACE in patients with type 2 diabetes and known CVD on empagliflozin
TRIUMPH-1 (28.3%, 80 weeks, N=2,339) and TRIUMPH-4 (28.7%, 68 weeks, N=445) produced nearly identical efficacy results despite different populations and durations
Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Companys ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Companys public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR
GLP-1, or Glucagon-Like Peptide-1, is a hormone that helps to regulate blood sugar levels
The benzyl alcohol component permits multi-dose use over a typical 28-day window
Later in the protocol, you burn through vials rapidly and need consistent supply