New Study Data: JANUVIA™ Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2 Diabetes

Business Wire, Nov 21, 2008

NATIONAL HARBOR, Md. -- New data presented at the 61st Annual Scientific Meeting of the Gerontological Society of America showed JANUVIA([TM]) (sitagliptin), a diabetes medicine from Merck & Co., Inc., significantly reduced blood sugar levels in elderly patients with type 2 diabetes and was not associated with hypoglycemia (low blood sugar). In this study of 206 patients aged 65 to 96 years, there were no reports of hypoglycemia in either the JANUVIA or the placebo groups. Advanced age contributes to the risk of hypoglycemia.

JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic 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. As is typical with other anti-hyperglycemic agents used in combination with a sulfonylurea, when JANUVIA is used in combination with a sulfonylurea, a class of medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea may be required to reduce 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, M.D., director of the Institute for Aging Research and Animal Physiology Core, Diabetes Research Training Center at the Albert Einstein College of Medicine. "In this study, JANUVIA effectively helped lower blood glucose levels and was not associated with hypoglycemia."

JANUVIA significantly reduced blood sugar levels with no reported cases of hypoglycemia in this study

In this 24-week randomized, double-blind, placebo-controlled trial, 206 patients aged 65 years and older (mean age of 72 years) with baseline A1C1 levels of 7.0 to 10.0 percent (baseline mean of 7.8 percent) received JANUVIA (n=102) or placebo (n=104). In patients treated with JANUVIA, the mean placebo-adjusted A1C reduction from baseline at 24 weeks was 0.7 percent (JANUVIA, -0.5 percent vs. placebo, +0.2 percent; p<0.001). More than twice as many patients treated with JANUVIA had an A1C less than the American Diabetes Association recommended A1C goal of 7.0 percent at 24 weeks compared with patients given placebo (35 percent vs. 15 percent, respectively; p<0.05). Patients aged 75 years and older (n=30) had a similar response to treatment with JANUVIA as those under age 75 (n=71) (mean placebo-adjusted A1C reductions of 0.7 percent in both groups, p=0.988). In patients treated with JANUVIA, the mean placebo-adjusted reductions from baseline in fasting plasma glucose (FPG) and 2-hour post prandial glucose (PPG) were 27 and 61 mg/dL, respectively (p<0.001).

Safety parameters were also assessed in this study. For patients in the JANUVIA or placebo group, respectively, the incidences of overall adverse experiences (AEs), serious AEs and AEs leading to discontinuation were 46 and 53 percent, 7 and 13 percent and 5 and 3 percent.

Clinical AEs of hypoglycemia and selected gastrointestinal (GI) events (nausea, vomiting, abdominal pain and diarrhea) as well as body weight were pre-specified as AEs of interest. No cases of hypoglycemia were reported in patients treated with JANUVIA. The incidence of pre-specified GI events was similar between the JANUVIA and placebo groups. AEs of constipation (ranging from mild to severe in intensity, all non-serious) were reported for five patients (5 percent) in the JANUVIA group and zero patients in the placebo group. Mean weight loss from baseline was 1.1 kg in patients treated with JANUVIA (p=0.079) and 1.7 kg in patients given placebo (p=0.010).

An important predictive factor of the magnitude of A1C reduction in response to anti-hyperglycemic therapy is a patient's starting level of A1C - the higher the starting level of A1C, the greater the expected reduction in A1C following treatment, and this was observed in this study. In a subgroup analysis of patients grouped by severity of starting baseline A1C, the mean placebo-adjusted reduction was 1.6 percent for patients with baseline A1C of 9.0 percent or more (n=13), while placebo-adjusted reductions of 0.9 percent and 0.5 percent were seen with baseline A1C values of 8 to less than 9 percent (n=20) and less than 8 percent (n=68), respectively (p=0.043, for treatment by subgroup interaction).

Type 2 diabetes in the elderly

Type 2 diabetes can be difficult and complicated to treat in older patients. Treatments for elderly patients must be selected with care, in light of the frequent presence of comorbidities or other medication use. Achieving target glycemic goals while avoiding low blood sugar can also be a challenge for aging patients with type 2 diabetes, as advanced age itself can contribute to the risk of hypoglycemia.