A new analysis presented at the American Diabetes Association (ADA) 68th Annual Scientific Sessions showed treatment with Januvia (sitagliptin), Merck & Co., Inc.'s diabetes medicine, was associated with a 93 per cent lower risk of having a confirmed symptomatic hypoglycaemic event on a given day compared to treatment with glipizide, a sulfonylurea.
This 52-week intent to treat analysis was based on 37 events in the Januvia group and 492 events in the glipizide group. Both agents were added to ongoing metformin therapy in patients with type II diabetes and were associated with similar reductions in A1Ci (0.5 percent for Januvia and 0.6 percent for glipizide in the intent-to-treat patient population).
Januvia is indicated, as an adjunct to diet and exercise, to improve glycolic control in adult patients with type 2 diabetes. Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Januvia has not been studied in combination with insulin. Januvia is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis and angioedema.
Hypoglycaemia is a common side effect of some oral diabetes medications. The risk of hypoglycaemia observed in this study with Januvia compared to glipizide was lower in older patients compared with younger patients.
As is typical with other anti-hyperglycaemic agents used in combination with a sulfonylurea, when Januvia is used in combination with a sulfonylurea, a class of medications known to cause hypoglycaemia, the incidence of hypoglycaemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycaemia.
Januvia is a selective, once-daily dipeptidyl peptidase-4 (DPP-4) inhibitor that enhances a natural body system, called the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, Januvia works only when blood sugar is elevated to address diminished insulin due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction.
"When treating patients with type II diabetes, it is important for physicians to balance lowering blood glucose levels with avoiding hypoglycaemia," said Nir Barzilai, MD, professor, department of Medicine and department of Molecular Genetics, director, Institute for Aging Research, Albert Einstein College of Medicine, New York.
The recommended dose of Januvia is 100 mg once daily, with or without food, for all approved indications. No dosage adjustment is needed for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency.