"The results of this investigational study of sitagliptin as initial combination therapy with pioglitazone continues to extend the range of diabetes treatment regimens with which sitagliptin demonstrates significant blood sugar-lowering efficacy," said John Amatruda, M.D., SVP and Franchise Head, Diabetes and Obesity, Merck & Co., Inc.
*Note, initial therapy with a combination of pioglitazone and sitagliptin is not currently licensed.
Sitagliptin is a highly selective, once-daily DPP-4 inhibitor that enhances a natural body system called the incretin system, to help regulate blood sugar by increasing blood levels of active GLP-1 and GIP hormones; it inhibits DPP-4 over 24 hours. [ii] The fixed dose combination of sitagliptin and metformin targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver. [iii] Sitagliptin is the first approved medicine in the DPP-4 inhibitor class of oral treatments. It has been approved in over 80 countries and to-date, there have been more than 11.1 million prescriptions dispensed worldwide. [iv]
Study of initial combination therapy with sitagliptin and pioglitazone*1
A total of 497 patients with baseline HbA1c [1]* levels of 8.0 to 12.0 percent (mean baseline of 9.5 percent) received sitagliptin 100 mg once daily and pioglitazone 30 mg once daily or pioglitazone 30 mg once daily alone. The primary endpoint was HbA1c change from baseline at week 24. In this 24-week randomized, double-blind, placebo-controlled trial, initial treatment with sitagliptin and pioglitazone provided an HbA1c reduction of 2.4 percent from baseline (n=251) compared with 1.5 percent with pioglitazone alone (n=246), a between-group difference of 0.9 percent (p
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