OBJECTIVE This study compared the efficacy and safety of once-weekly dulaglutide, a glucagonlike peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes. The primary objective was noninferiority of dulaglutide 1.5 mg to glargine in the HbA1c change from baseline at 52 weeks. RESEARCH DESIGN AND METHODS In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine. RESULTS The baselinemean ± SD HbA1c was 8.1 ± 1.0% (65.5 ± 10.8mmol/mol). The least squares mean ± SE HbA1c change from baseline to the primary end point was 21.08 ± 0.06% (211.8 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, 20.76 ± 0.06% (28.3 ± 0.7 mmol/mol) for dulaglutide 0.75 mg, and 20.63 ± 0.06% (26.9 ± 0.7 mmol/mol) for glargine, with an end point mean ± SD dose of 29 ± 26 units (0.3360.24 units/kg), and a fasting plasma glucose (mean6SD) of 118623 mg/dL from self-monitored plasma glucose. Statistical criteria for superiority were met with dulaglutide 1.5 mg and for noninferiority with dulaglutide 0.75 mg. More patients on dulaglutide 1.5 mg achieved HbA1c targets <7.0% (53 mmol/mol) versus glargine (P < 0.001). Body weight decreased with dulaglutide and increased with glargine. Total hypoglycemia rates were lower with dulaglutide; severe hypoglycemia was minimal. Increases in pancreatic enzymes were observed for dulaglutide. Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine. CONCLUSIONS Once-weekly dulaglutide 1.5 mg, compared with daily insulin glargine without forced titration, demonstrated greater HbA1c reduction and weight loss, with a higher incidence of gastrointestinal adverse events and a lower risk of hypoglycemia.

Efficacy and safety of once- weekly dulaglutide versus insulin glargine in patients with type 2 Diabetes on metformin and glimepiride (AWARD-2)

GIORGINO, Francesco;
2015-01-01

Abstract

OBJECTIVE This study compared the efficacy and safety of once-weekly dulaglutide, a glucagonlike peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes. The primary objective was noninferiority of dulaglutide 1.5 mg to glargine in the HbA1c change from baseline at 52 weeks. RESEARCH DESIGN AND METHODS In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine. RESULTS The baselinemean ± SD HbA1c was 8.1 ± 1.0% (65.5 ± 10.8mmol/mol). The least squares mean ± SE HbA1c change from baseline to the primary end point was 21.08 ± 0.06% (211.8 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, 20.76 ± 0.06% (28.3 ± 0.7 mmol/mol) for dulaglutide 0.75 mg, and 20.63 ± 0.06% (26.9 ± 0.7 mmol/mol) for glargine, with an end point mean ± SD dose of 29 ± 26 units (0.3360.24 units/kg), and a fasting plasma glucose (mean6SD) of 118623 mg/dL from self-monitored plasma glucose. Statistical criteria for superiority were met with dulaglutide 1.5 mg and for noninferiority with dulaglutide 0.75 mg. More patients on dulaglutide 1.5 mg achieved HbA1c targets <7.0% (53 mmol/mol) versus glargine (P < 0.001). Body weight decreased with dulaglutide and increased with glargine. Total hypoglycemia rates were lower with dulaglutide; severe hypoglycemia was minimal. Increases in pancreatic enzymes were observed for dulaglutide. Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine. CONCLUSIONS Once-weekly dulaglutide 1.5 mg, compared with daily insulin glargine without forced titration, demonstrated greater HbA1c reduction and weight loss, with a higher incidence of gastrointestinal adverse events and a lower risk of hypoglycemia.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11586/170428
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