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New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2 Diabetes
Date:11/21/2008

ntly 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 g
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