Sitagliptin, a Selective DPP-4 Inhibitor, Improves Glycemic Control when Added to a Sulfonylurea or to a Sulfonylurea and Metformin in Patients with Type 2 Diabetes

Hermansen, Kjeld; Kipnes, Mark; Luo, Edmund; Fanurik, Debra; Khatami, Hootan; Stein, Peter P.
June 2007
Diabetes;Jun2007 Supplement 1, Vol. 56, pA143
Academic Journal
Efficacy and safety of sitagliptin (SITA) were examined in patients with type 2 diabetes and inadequate glycemic control (A1C 7.5% to 10.5%) on glimepiride (G) alone or G plus metformin (G+MF). After a titration/stabilization period on G (≥4 mg/day) ± MF (≥ 1500 mg/day) and a 2-week placebo (PBO) run-in, 441 patients (mean baseline A1C 8.3%) were randomized to the addition of SITA 100 mg q.d. or PBO for 24 weeks. Of these patients, 212 were on G alone (106 each on SITA or PBO), and 229 on G+MF (116 on SITA, 113 on PBO). The primary endpoint was A1C change from baseline for the entire cohort. After 24 weeks, the addition of SITA reduced A1C by -0.7% (p<0.001) relative to PBO (LS mean change from baseline -0.5% with SITA, +0.3% with PBO) in the entire cohort. Patients on G+MF had a PBO-subtracted A1C change from baseline of -0.9%, and patients on G alone had a PBO-subtracted change from baseline of -0.6%. For the entire cohort, SITA significantly (p<0.001) reduced fasting plasma glucose by 20 mg/dL (1.1 mmol/L) and 2-hour postprandial glucose by 36 mg/dL (2.0 mmol/L) relative to PBO at Week 24. Similar results were observed in the G alone and G+MF strata. HOMA-β was also signficantly (p<0.05) improved with SITA relative to PBO. For the entire cohort, there was a higher incidence of overall adverse experiences (AEs) (60 vs 47%) and drug-related AEs (15 vs 7%) with SITA vs. PBO, with a higher incidence of hypoglycemia AEs (12 vs 2%, respectively) contributing to these differences. At Week 24, body weight was modestly increased with SITA compared with PBO (LS mean change from baseline +0.8 vs -0.4 kg, respectively; p<0.001). In this study, dual or triple therapy with SITA added to G or G+MF improved glycemic control in the fasting and postprandial states. Since co-administration of SITA with MF has an additive effect on active GLP-1 levels (Migoya et al., ADA 2007 submitted), this may have contributed to the greater A1C efficacy observed with triple therapy (SITA with G+MF) compared to dual therapy (SITA with G). The addition of SITA was generally well tolerated; the higher rate of hypoglycemia was consistent with the degree of glycemic improvement and comparable to findings from other add-on to sulfonylurea studies.



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