on to
placebo or JANUVIA.
Treatment with JANUVIA at 100 mg daily provided significant
improvements in A1C, FPG, and 2-hour PPG compared to placebo (Table
2). In the 18-week study, 9% of patients receiving JANUVIA 100 mg and
17% who received placebo required rescue therapy. In the 24-week
study, 9% of patients receiving JANUVIA 100 mg and 21% of patients
receiving placebo required rescue therapy. The improvement in A1C was
not affected by gender, age, race, or baseline BMI. As is typical for
trials of agents to treat type 2 diabetes, mean response to JANUVIA in
A1C lowering appears to be related to the degree of A1C elevation at
baseline. Overall, the 200 mg daily dose did not provide greater
glycemic efficacy than the 100 mg daily dose. The effect of JANUVIA on
lipid endpoints was similar to placebo. Body weight did not increase
from baseline with JANUVIA therapy in either study, compared to a
small reduction in patients given placebo.
Table 2
Glycemic Parameters in 18- and 24-Week Placebo-Controlled Studies of
JANUVIA in Patients with Type 2 Diabetes+
----------------------------------------------------------------------
18-Week Study 24-Week Study
----------------- -----------------
JANUVIA Placebo JANUVIA Placebo
100 mg 100 mg
------------------------------------------- -------- -------- --------
A1C (%) N = 193 N = 103 N = 229 N = 244
------------------------------------------- -------- -------- --------
Baseline (mean) 8.0 8.1 8.0 8.0
------------------------------------------- -------- -------- --------
Change from baseline (adjusted
mean++) -0.5 0.1 -0.6 0.2
------------------------------------------- ------
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