News Article
Sitagliptin Plus Metformin Shows 2-Year Benefit for Blood Glucose
ROME (EGMN) - A 1.7% reduction in hemoglobin A
This reduction, seen after 104 weeks of total follow-up, was significantly better than the reductions achieved with either drug alone or placebo, and was associated with no more adverse events than metformin monotherapy.
Dr. Debora Williams-Herman of Merck Research Laboratories in Rahway, N.J., presented the data at the annual meeting of the European Association for the Study of Diabetes.
The extension trial involved 454 patients who had already completed 1 year of treatment with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin alone at a dose of 100 mg/day; twice-daily treatment with metformin alone at a dose of 500 mg or 1000 mg; both drugs in combination (50 mg sitagliptin plus either 500 or 1000 mg of metformin); or placebo and 100 mg metformin. The results of this investigation were published last year and showed that, at 54 weeks' follow-up, the mean change from baseline in hemoglobin A
Now, at 2 years, the results show a similar and sustained reduction in HbA
Almost two-thirds (60%) of patients given the sitagliptin plus higher-dose metformin combination achieved an HbA
As expected, and as reported in other trials of antidiabetic agents, patients who had a higher initial baseline HbA
Dr. Williams-Herman reported that 5 of 107 patients (5%) given the sitagliptin plus higher-dose metformin combination experienced hypoglycemia during the extension study (i.e., between weeks 54 and 104). This can be compared with 2 of 100 patients (2%) given sitagliptin plus metformin 500 mg, 2 of 88 patients (2%) given metformin 1000 mg, 1 of 85 patients (2%) given metformin 500 mg, and 1 of 42 patients (2%) given placebo and then 1000 mg metformin. No patients given sitagliptin monotherapy developed hypoglycemia during the extension study.
"In patients with type 2 diabetes inadequately treated with diet and exercise, initial combination therapy with sitagliptin and metformin over 2 years showed substantial glycemic improvement," Dr. Williams-Herman said.
Commenting on these data at a press briefing organized by Merck Sharp and Dohme, which markets sitagliptin, Dr. Bernard Charbonnel of the University Hospital of Nantes, France, said sitagliptin and metformin used together produced "powerful glycemic improvements." He added: "Around 60% of patients achieved the HbA
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