Monthly Archives: November 2014

Progression of Modern Therapeutics for Type 2 Diabetes

Since the mid 1990’s there have been a total of 22 NME (new molecular entity) drug approvals for Type 2 Diabetes (click on drugs for Type 2 Diabetes). Before 1995, therapies for Type 2 Diabetes belonged to only one pharmacologic class (not including insulin), i.e., sulfonylureas. In addition to this significant number of NME approvals, what’s remarkable is the number of pharmacologic classes involved, or mechanisms of action, which is ten (again, not including insulin).

These ten pharmacologic classes, including the number of approved NME’s, the number of years of regulatory approvals per class, and the time periods involved, are as follows (based on FDA’s Drugs@FDA database, and not including new formulations of previously approved drugs):

  • Sulfonylureas (5 NME’s; over 37 years & 1 month; 1958-1995);
  • Biguanides (1 NME; 1995);
  • Alpha glucosidase inhibitors (2 NME’s; over 1 year & 3 months; 1995-1996);
  • Thiazolidinediones (3 NME’s; over 2 years & 5 months; 1997-1999);
  • Meglitinides (2 NME’s; over 3 years & 0 months; 1997-2000);
  • GLP-1 receptor agonists (4 NME’s; over 9 years & 4 months; 2005-2014);
  • Amylin analogs (1 NME; 2005);
  • DPP-4 inhibitors (4 NME’s; over 6 years & 3 months; 2006-2013);
  • Dopamine agonists (1 NME; 2009); and
  • SGLT2 inhibitors (3 NME’s; over 1 year & 4 months; 2013-2014).

Considering the complex pathophysiology of Type 2 Diabetes, and these ten different pharmacologic classes with a total of twenty-five approved NME’s (one was discontinued because of toxicity), one wonders if all of these approved NME’s have the same or similar long-term therapeutic benefits, adverse effects aside. While metformin (Glucophage) is still part of the core therapeutic strategy for Type 2 Diabetes, price and formularies aside, how can  prescribers choose the most appropriate alternative or additional drug for the individual patient? This question becomes even more relevant when one considers drug approvals based on surrogate endpoints for chronic diseases, such as Type 2 Diabetes.

Refer to page 14 of Progression Of Modern Therapeutics (2013) available under Reports on this website; this Report also includes the methodology used.