Two-Year Sitagliptin With or Without Metformin Shows Strong and Durable Effects in Type 2 Diabetes: Presented at EASD

To print: Select File and then Print from your browser's menu
---------------------------------------------------------------------------------------
Title: Two-Year Sitagliptin With or Without Metformin Shows Strong and Durable Effects in Type 2 Diabetes: Presented at EASD
URL: http://www.pslgroup.com/dg/22BBC6.htm
Doctor's Guide
September 10, 2008

By Jill Stein

ROME -- September 10, 2008 -- Treatment with sitagliptin and initial combination therapy with sitagliptin and metformin produce strong and lasting improvements in glycaemic levels in patients with type 2 diabetes, researchers reported here at the European Association for the Study of Diabetes (EASD) 2008.

"In patients on initial combination therapy with sitagliptin and metformin, we saw substantial glycaemic improvement and durable efficacy out to 2 years, and the safety profile out to 2 years was also favourable," said Deborah Williams-Herman, MD, Merck Research Laboratories, Rahway, New Jersey, in a presentation on September 9.

After the initial, double-blind, 54-week phase of the trial, consenting patients continued in a double-blind, 50-week extension phase. Subjects who had been randomised initially to active treatments remained on the same treatments during the extension phase. All subjects who had been randomised initially to placebo were switched to metformin 2,000 mg at week 24.

Dosing regimens of these daily treatments were as follows: sitagliptin 100 mg/metformin 2,000 mg (S100/M2000 divided daily doses); sitagliptin 100 mg/metformin 1,000 mg (S100/M1000 divided daily doses); metformin 2,000 mg (M2000 divided daily doses); metformin 1,000 mg (M1000 divided daily doses); and sitagliptin 100 mg QD (S100).

Dr. Williams-Herman presented 104-week results for patients who were originally randomised to active treatment and who entered the extension. Primary efficacy analysis required at least 1 measurement in the extension phase ("all-patients-treated" or APT group).

Of the 1,091 patients randomised in the initial phase of the study, 511 patients completed week 54, and 454 patients were eligible for enrolment in the extension phase. No patient who entered the extension had received rescue therapy through week 54.

At baseline, extension-phase subjects were a mean of 54.4 years old; they had a mean body mass index (BMI) of 31.3 and a mean haemoglobin (Hb) A1C level of 8.6%. Slightly more than half of patients were female.

At week 104 for the APT group, the change in Hb A1C from baseline was -1.7% for S100/M2000, -1.4% for S100/M1000, -1.3% for M2000, -1.1% for M1000, and -1.2% for S100.

Rates of subjects with Hb A1C <7% at week 104 were 60% for the S100/M2000 group, 45% for the S100/M1000 group, 45% for the M2000 group, 28% for the M1000 group, and 32% for the S100 group.

"Overall, the results show that glycaemic response was generally durable over time across treatments and that all treatments were generally well tolerated," Dr. Williams-Herman concluded.

Funding for the study was provided by Merck & Co.

[Presentation title: Two-Year Treatment With Sitagliptin and Initial Combination Therapy of Sitagliptin and Metformin Provides Substantial and Durable Glycemic Control in Patients With Type 2 Diabetes. Abstract 73]

http://www.docguide.com

Return to News Story Page

webmaster@pslgroup.com