MedicalResearch.com Interview with:
Peter Stein, M.D.
Vice president, Clinical Research for Diabetes and Dndocrinology
Merck Research Laboratories.
MedicalResearch: What are the main findings of the study?
Dr. Stein: This late-breaking observational study assessed the differences in time to initiation of insulin use and the proportion of the population initiating insulin among patients with type 2 diabetes taking the combination of JANUVIA
® (sitagliptin) and metformin, and patients taking the combination of a sulfonylurea and metformin. In this study, patients treated with a combination of JANUVIA and metformin initiated insulin therapy at a slower rate during the period of observation than patients treated with a combination of sulfonylurea and metformin.
In this study, the percentages of patients initiating insulin by years one through six were 3.6, 8.4, 12.9, 17.7, 22.4, 26.6 for patients taking JANUVIA; and 4.1, 9.4, 14.6, 21.0, 27.1, 34.1 for patients taking a sulfonylurea. An analysis of the data overall (Kaplan-Meier method) showed that patients taking JANUVIA progressed more slowly to insulin use than patients taking a sulfonylurea (p=0.0034). The Cox proportional hazard regression analysis indicated that by year six, patients in the JANUVIA group were 24 percent less likely to initiate insulin during the period of observation compared to patients taking a sulfonylurea (HR = 0.76; p = 0.0011).
Similar results were observed in the sub-group of patients with a baseline
A1C of less than 9 percent (HR = 0.77; p = 0.0128]; however there was no statistically significant difference in time to insulin initiation in the sub-group with a baseline A1C of greater than or equal to 9 percent (HR = 0.75; p = 0.1818).
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