Sitagliptin Reduces Blood Glucose In Elderly Type 2’s

The 24-week randomized, double-blind, placebo-controlled trial enrolled 206 patients aged 65 years to 95 years with baseline HbA1c levels of 7% to 10%. Researchers randomly assigned 102 patients to once-daily sitagliptin (Januvia, Merck) 100 mg (50 mg if estimated creatinine clearance was 30-50 mL per minute) and 104 patients to placebo.

“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,” Nir Barzilai, MD, director of the Institute for Aging Research at Albert Einstein College of Medicine, said in a press release.

At 24 weeks, patients assigned to sitagliptin experienced a mean placebo-adjusted HbA1c reduction of 0.7% from baseline (–0.5% for sitagliptin vs. 0.2% for placebo; P<.001). More than twice as many sitagliptin-treated patients achieved an HbA1c <7% compared with placebo-treated patients (35% vs. 15%; P<.05).

Responses were similar among patients aged 75 years and older (n=30) and patients younger than 75 years (n=71) treated with sitagliptin. The mean reduction in HbA1c was 0.7% (P=.988).

Sitagliptin was also associated with reductions in fasting plasma glucose (27 mg/dL) and two-hour postprandial glucose (61 mg/dL) from baseline to week 24 (P<.001). Mean weight loss from baseline was 1.1 kg with sitagliptin (P=.079) and 1.7 kg with placebo (P=.010).

According to the researchers, sitagliptin monotherapy was efficacious and generally well-tolerated in elderly patients. The incidence of overall adverse events was 46% in the sitagliptin group compared with 53% in the placebo group and serious adverse events were observed in 7% of sitagliptin-treated patients compared with 13% of placebo-treated patients. Adverse events leading to discontinuation were low (sitagliptin, 5%; placebo, 3%). No hypoglycemia was reported in either group.
A subgroup analysis revealed that the greatest reductions were seen in patients with baseline HbA1c ≥9% (1.6% reduction) followed by HbA1c of 8% (0.9%) and HbA1c <8% (0.5%).

“Together, these data suggest that sitagliptin is safe in the elderly and associated with fewer adverse events,” stated, Barzilai.
“Also, this study evaluated once-daily sitagliptin, and having to take just one antidiabetes drug in the morning is a major advantage for the elderly,” he said.

Barzilai N. LB-77. Presented at: Gerontological Society of America 61st Annual Meeting; Nov. 21-25, 2008; National Harbor, Md.