Januvia in combination with metformin or taken alone lowers blood sugar

Sep 29 2009

A post-hoc analysis, presented at the 45^th Annual Meeting of the European Association for the Study of Diabetes (EASD), of data pooled from studies of 104 weeks in duration showed ‘Januvia^®’ (sitagliptin), when taken alone or in combination with metformin, provided significant blood sugar lowering over two years.

“This analysis shows that, among patients with type 2 diabetes who completed two years of follow up, sitagliptin substantially lowered HbA1c levels,” said John Amatruda, M.D., Senior Vice President and Franchise Head, Diabetes and Obesity, Merck Research Laboratories (MRL), Merck & Co., Inc. “Data demonstrating the efficacy and safety profiles of sitagliptin is an important consideration when physicians are treating patients who have chronic illnesses like diabetes.”

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 levels of active GLP-1 and GIP hormones; it inhibits DPP-4 over 24 hours. 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. The fixed dose combination is not available in some EU countries, including the UK. Sitagliptin is the first approved medicine in the DPP-4 inhibitor class of oral treatments. It has been approved in more than 80 countries and to date, there have been more than 15 million prescriptions dispensed worldwide.

Efficacy with Sitagliptin Over Two Years

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 percent who were not taking any diabetes medications upon entry. The mean HbA1c in the patients>

The studies had established criteria to specify when patients should start additional antihyperglycaemic therapy or discontinue from the studies, and these criteria, including either measurements of fasting plasma glucose (FPG) or HbA1c, became stricter over time. The analyses excluded data obtained after patients had started additional medicines.

Overall, 67 out of 147 patients (46 percent) 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 percent who were taking metformin only>

Among those already on metformin, 283 out of 852 patients (33 percent) who added sitagliptin to metformin received glycaemic rescue medication or discontinued treatment due to lack of efficacy (i.e. patients not meeting the progressively stricter, protocol-specified glycaemic criteria and/or not meeting the investigator’s expectations of glycaemic improvement) over the two years.

Other Sitagliptin Data Presented at EASD

During this year's meeting, data will be presented on the safety and efficacy of sitagliptin in combination with other diabetes treatments. Results from an investigational study (presentation 747) will review the effect of initial combination therapy with sitagliptin and pioglitazone on blood sugar control. Initial therapy with a combination of pioglitazone and sitagliptin is not currently licensed in Europe.

Another study (presentation 751) will review the effect of initial treatment with the fixed dose combination of sitagliptin and metformin on blood sugar control in patients with type 2 diabetes, compared with metformin alone. Initial therapy with the fixed-dose combination drug is not currently licensed in Europe.