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Initial treatment with sitagliptin phosphate 50 mg twice daily in combination
with metformin 1,000 mg twice daily provided substantial reductions of post
prandial, or post-meal, glucose (PPG) levels and fasting plasma glucose (FPG)
levels in patients with type 2 diabetes, according to new data. Patients with
a mean baseline 2-hour PPG of 287 mg/dL (n=152) achieved reductions of 117 mg/dL,
and patients with a mean baseline FPG of 197 mg/dL (n=180) achieved reductions
of 70 mg/dL, compared to placebo (primary analysis of all patients treated,
p<0.001).
"Typically, oral medications for type 2 diabetes principally either reduce
post-meal glucose levels or reduce fasting blood glucose levels. These study
data are important because they showed substantial reductions in both measures
of blood glucose levels, PPG and FPG, with sitagliptin phosphate plus metformin,"
said John Amatruda, M.D., vice president, clinical research, Merck & Co.,
Inc.
The American Diabetes Association (ADA) recommends that post prandial (PPG)
levels should be below 180 mg/dL, and pre-prandial (FPG) levels should not rise
above 130 mg/dL in patients with type 2 diabetes. Blood glucose levels both
after meals and after fasting contribute to the A1C level, which is a commonly
used measure of a person’s average blood glucose over a two- to three-month
period.
This study is part of the clinical program supporting JANUMET, an investigational
therapy combining Merck’s sitagliptin phosphate with metformin. In the
study, combination treatment with sitagliptin phosphate plus metformin was generally
well tolerated and showed no meaningful differences in tolerability compared
to metformin alone. Side effects of combination treatment with sitagliptin phosphate
50 mg twice daily plus metformin 1,000 mg twice daily compared to metformin
1,000 mg twice daily alone included diarrhea (9 percent vs. 10 percent, respectively),
nausea (6 percent vs. 8 percent, respectively), abdominal pain/discomfort (3
percent vs. 5 percent, respectively) and vomiting (3 percent vs. 1 percent,
respectively).
A1C efficacy results of sitagliptin phosphate plus metformin as initial therapy
This 24-week, randomized, double-blind, placebo-controlled study involved
1,091 untreated patients with type 2 diabetes (mean baseline A1C = 8.8 percent).
After a run-in period of diet, exercise and/or placebo, patients were randomized
to receive one of six daily treatments: sitagliptin phosphate 50 mg/metformin
500 mg twice daily (n=190), sitagliptin phosphate 50 mg/metformin 1,000 mg twice
daily (n=182), metformin 500 mg twice daily (n=182), metformin 1,000 mg twice
daily (n=182), sitagliptin phosphate 100 mg once daily (n=179), and placebo
(n=176).
As previously disclosed at a meeting of the European Association for the Study
of Diabetes (EASD) in September, this study demonstrated a significant mean
placebo-subtracted reduction in A1C of 2.1 percent from a mean baseline A1C
of 8.7 percent (primary analysis of all patients treated, p>0.001) in the
patients treated with sitagliptin phosphate 50 mg twice daily combined with
metformin 1,000 mg twice daily, as initial therapy.
In clinical trials, JANUVIA demonstrated an overall incidence of side effects
comparable to placebo. The most common side effects reported with JANUVIA (greater
than or equal to 5 percent and higher than placebo) were stuffy or runny nose
and sore throat, upper respiratory infection, and headache.
Presented at the 19th World Diabetes Congress in Cape Town.
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