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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

roup. 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.

Recognition of hypoglycemia may be diminished in the elderly. Symptoms of hypoglycemia may include shakiness, dizziness, sweating, hunger, headache, pale skin color, sudden moodiness or behavior changes, clumsy or jerky movements, seizure, confusion and unconsciousness.

Use of JANUVIA in the elderly

Of the total number of subjects (n=3,884) in pre-approval clinical safety and efficacy studies of JANUVIA, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported cli
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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 
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