Merck & Co. Inc. (MRK), a global research-driven pharmaceutical company, presenting a new data on Friday, said its diabetes drug Januvia, or sitagliptin, significantly reduced blood sugar levels in elderly patients with type-2 diabetes and was not associated with low blood sugar.
The Whitehouse Station, New Jersey-based company said the 24-week study involved 206 patients aged 65 to 96 years and there were no reports of low blood sugar, or hypoglycemia, in either the Januvia or the placebo groups. Advanced age itself can contribute to the risk of hypoglycemia.
"The elderly population presents challenges for the treatment of type 2 diabetes, as various factors can affect the ability to lower these patients' blood sugar to target levels," said lead study investigator Nir Barzilai.
Januvia is prescribed, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type-2 diabetes.
Merck noted that in clinical studies, the most common adverse reactions reported with Januvia were stuffy or runny nose and sore throat, upper respiratory infection and headache.
Merck warned that Januvia should not be used in patients with type-1 diabetes or for the treatment of diabetic ketoacidosis. Januvia should not be given to patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis and angioedema.
Additionally, Januvia has not been studied in combination with insulin. There have been post-marketing reports of hypersensitivity reactions in patients treated with Januvia. With respect to sitagliptin, Merck said its clinical development program is robust and continues to expand with 55 studies completed or underway.
It is estimated that approximately 7,400 patients have been treated with sitagliptin out of about 12,000 patients who have participated in the company's clinical studies.
Additionally, in clinical studies, approximately 2,300 patients have been treated with sitagliptin for more than one year and, of these, approximately 500 patients have been treated for at least two years.
MRK is trading down $0.02 or 0.08% at $23.45 on a volume of about 2.27 million shares.
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