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Efficacy and Safety of Bydureon Versus Metformin, Pioglitazone, and Sitagliptin as Monotherapy

In a once weekly injection of exenatide for Drug-Naive Patients with Type 2 Diabetes (DURATION-4) in a 26-week double-blind study they found that exenatide once weekly (EQW) was noninferior to metformin (MET) but not pioglitazone (PIO) and superior to sitagliptin (SITA) with regard to HbA1c reduction at 26 weeks….

Of the agents studied, EQW and MET provided similar improvements in glycemic control along with the benefit of weight reduction and no increased risk of hypoglycemia.

The methods used were the patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n=248), MET 2,000 mg/day + SC placebo (n=246), PIO 45 mg/day + SC placebo (n=163), or SITA 100 mg/day + SC placebo (n=163) for 26 weeks.

MET and PIO therapies were increased to maximum–tolerated dosages. The injections with EQW or placebo were administered weekly, while oral medication or placebo was administered daily.

The results showed that baseline characteristics were as follows: 59% men, 67% Caucasian, mean age 54 years, HbA1c 8.5%, fasting serum glucose 9.9 mmol/L, body weight 87.0 kg, and diabetes duration 2.7 years. HbA1c reductions (%) at 26 weeks (least–squares means) with EQW versus MET, PIO, and SITA were –1.53 vs. –1.48 (P=0.620), –1.63 (P=0.328), and –1.15 (P<0.001), respectively. Weight changes (kg) were –2.0 vs. –2.0 (P=0.892), +1.5 (P<0.001), and –0.8 (P<0.001), respectively. Common adverse events were as follows: EQW, nausea (11.3%) and diarrhea (10.9%); MET, diarrhea (12.6%) and headache (12.2%); PIO, nasopharyngitis (8.6%) and headache (8.0%); and SIT, nasopharyngitis (9.8%) and headache (9.2%). Minor (confirmed) hypoglycemia was rarely reported. No major hypoglycemia occurred.

From the results it was concluded that,in these patients with type 2 diabetes who were naive to antihyperglycemic therapy, all four treatments resulted in improvements in HbA1c, and a majority of EQW-, MET-, and PIO-treated patients achieved a target HbA1c of 7.0%.

This study recognizes that guidelines typically recommend MET as the first agent used, because it is inexpensive and supported by long-term data. Of the agents studied, EQW and MET provided similar improvements in glycemic control along with the benefit of weight reduction and no increased risk of hypoglycemia. There were no unexpected findings with regard to safety or tolerability. Based on these 26-week data, EQW is a once weekly dosing option for initial therapy. Longer-term studies will be required to assess the durability of the observations in this study.

Diabetes Care, 01/04/2012