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The U.S. Food and Drug Administration approved Onglyza (saxagliptin), a
once-daily tablet to treat Type 2 diabetes in adults on July 31, 2009. The
medication is intended to be used with diet and exercise to control high blood
sugar levels. The products which are currently on the market have side effects
such as weight gain and a lower than normal level of glucose in the blood.
Onglyza does not have such side effects.
The hormone insulin keeps blood sugar (glucose) levels within a narrow range
in people who don’t have diabetes. People with Type 2 diabetes are either
resistant to insulin or do not produce enough insulin to maintain normal blood
Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4)
inhibitors which stimulate the pancreas to make more insulin after eating a
Saxagliptin added to submaximal glyburide therapy led to statistically
significant improvements vs. uptitration of glyburide alone across key
glycaemic parameters and was generally well tolerated. 
Saxagliptin + metformin as initial therapy led to statistically significant
improvements compared with either treatment alone across key glycaemic
parameters with a tolerability profile similar to the monotherapy components.
Clinical trials have demonstrated a dose-dependent inhibition of DPP-IV by
saxagliptin without serious side effects.  The most common side effects
observed with Onglyza are upper respiratory tract infection, urinary tract
infection, and headache. Other side effects include allergic-like reactions such
as rash and hives.
Ryan at Deutsche Bank North America said early-stage studies with saxagliptin
in monkeys revealed problems with skin toxicity, just like with Galvus However,
AstraZeneca spokesman David Albaugh and Bristol spokesman David Rosen
said that this side effect, i.e. the skin toxicity problems, have not surfaced in
human patients. 
FDA Approves New Drug Treatment for Type 2 Diabetes FDA NEWS
RELEASE July 31, 2009
 Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R.
Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic
control compared with uptitration of sulphonylurea in patients with type 2
diabetes: a randomised controlled trial. Int J Clin Pract. 2009 Jul 15 
Jadzinsky M, Pfützner A, Paz-Pacheco E, Xu Z, Allen E, Chen R; CV181-039
Investigators. Saxagliptin given in combination with metformin as initial therapy
improves glycaemic control in patients with type 2 diabetes compared with
either monotherapy: a randomized controlled trial. Diabetes Obes Metab. 2009
Jun;11(6):611-22.  Gallwitz B. Saxagliptin, a dipeptidyl peptidase IV inhibitor
for the treatment of type 2 diabetes. 2008 Dec;11(12):906-17.  New Bristol
diabetes drug shows promise CNN Money.com June 25 2007