Saxagliptin noninferior to sitagliptin for treating Type 2 diabetes

9 September 2010

Saxagliptin is noninferior to sitagliptin for the treatment of Type 2 diabetes when added to metformin therapy, show study results.

André Scheen (University of Liège, Belgium) and colleagues report the results of a phase IIIb study comparing saxagliptin 5 mg/day with sitagliptin 100 mg/day in addition to metformin 1500–3000 mg/day for the treatment of Type 2 diabetes.

The researchers enrolled 801 patients to the study, aged 58.4 years on average, with a glycated hemoglobin (HbA1c) level between 6.5% and 10.0%. Of these, 403 were randomly assigned to take saxagliptin and metformin and 398 to take sitagliptin and metformin for a period of 18 weeks.

Efficacy was measured by change in HbA1c from baseline at the end of the study. HbA1c was reduced at 18 weeks by 0.52% and 0.62% in the saxagliptin and sitagliptin groups, respectively. This amounted to a between-group difference of 0.09%, which was nonsignificant.

Overall, 97 patients (33.0%) in the saxagliptin plus metformin group and 117 patients (39.1%) in the sitagliptin plus metformin group achieved a HbA1c of less than 7.0% at week 18.

Both saxagliptin and sitagliptin were generally well tolerated, with an incidence of any treatment-related adverse event of 5.2% and 7.5%, respectively. The most common types of adverse events experienced by patients were influenza, urinary tract infection, nasopharyngitis, headache, and diarrhea. Hypoglycemia, which was mostly mild, occurred in around 3% of both groups.

Body weight decreased slightly in both groups by approximately 0.4 kg. “The absence of weight gain despite a significant improvement in glycemic control represents an advantage of dipeptidyl peptidase-4 inhibitors compared with other oral glucose-lowering agents such as sulphonylureas, or thiazolidinediones such as pioglitazone,” write the authors.

The results of this study are published in the journal Diabetes/Metabolism Research and Reviews.

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Diabetes Metab Res Rev 2010; Advance online publication