Pooled Clinical Data Analysis Shows 'Januvia' Lowers Blood Sugar Levels

Published: 29-Sep-2009

Combination targets three key defects of diabetes

MSD has presented a post-hoc analysis of data pooled from studies of 104 weeks in duration, which showed ‘Januvia’ (sitagliptin), when taken alone or in combination with metformin, provided blood sugar lowering over two years. The fixed-dose combination of sitagliptin and metformin targets three key defects of diabetes that include insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver.

According to the results presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD), in a post-hoc pooled analysis of data from two clinical trials evaluating sitagliptin as monotherapy, HbA1c over time was examined in 147 patients with a baseline HbA1c of 7.5 to 10.0% who were not taking any diabetes medications upon entry. The mean HbA1c in the patients (n=32) completing two years of sitagliptin monotherapy decreased from a baseline of 8.3 to 6.9% – into target guideline ranges.

67 out of 147 patients in the monotherapy group received glycaemic rescue medication or discontinued treatment because patients did not meet the progressively stricter glycaemic criteria and/or did not meet the investigator’s expectations of glycaemic improvement over the two years of study.

In the same post-hoc pooled analysis of data from two clinical trials evaluating the addition of sitagliptin to metformin therapy, HbA1c over time was examined in 852 patients with a baseline HbA1c of 7.0 to 10.0% who were taking metformin only (>/=1500 mg/day) at the screening visit. The mean HbA1c decreased from a baseline of 7.7 to 6.9% in patients (n=347) completing two years of treatment with sitagliptin as add-on therapy.

Among those already on metformin, 283 out of 852 patients who added sitagliptin to metformin received glycaemic rescue medication or discontinued treatment due to lack of efficacy over the two years, the company reported.

John Amatruda, senior vice president and franchise head of diabetes and obesity for Merck Research Laboratories at Merck & Co., said: “This analysis shows that, among patients with type 2 diabetes who completed two years of follow up, sitagliptin substantially lowered HbA1c levels. Data demonstrating the efficacy and safety profiles of sitagliptin is an important consideration when physicians are treating patients who have chronic illnesses like diabetes.”

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