Advancing Basal Insulin Replacement in Type 2 Diabetes Inadequately Controlled With Insulin Glargine Plus Oral Agents: A Comparison of Adding Albiglutide, a Weekly GLP-1 Receptor Agonist, Versus Thrice-Daily Prandial Insulin Lispro

• DOI: 10.2337/dc14-0001
• Publication Date: 2014-06-05T03:58:29Z
• Authors: Julio Rosenstock; Vivian A. Fonseca; Jorge L. Gross; Robert E. Ratner; Bo Ahrén; Francis C.C. Chow; Fred Yang; Diane Miller; Susan L. Johnson; Murray W. Stewart; Lawrence A. Leiter
• Keywords: Insulin lispro

GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal therapy. Harmony 6 was a randomized, open-label, active-controlled trial testing once-weekly albiglutide vs. thrice-daily lispro as add-on titrated once-daily glargine.Patients taking (with or without oral agents) with HbA1c 7-10.5% (53-91 mmol/mol) entered glargine standardization period, followed by randomization albiglutide, 30 mg weekly (n = 282), subsequently uptitrated 50 mg, if necessary, 281) while continuing metformin and/or pioglitazone. Glargine fasting plasma glucose of <5.6 mmol/L, and adjusted based on monitoring. The primary end point the difference in change from baseline at week 26.At 26, decreased -0.82 ± SE 0.06% (9.0 -0.66 (7.2 lispro; treatment difference, -0.16% (95% CI -0.32 0.00; 1.8 mmol/mol; P < 0.0001), meeting noninferiority (margin, 0.4%). Weight but increased (-0.73 0.19 kg +0.81 kg). mean dose 47 53 IU (albiglutide) 44 51 (lispro). Adverse events versus included severe hypoglycemia (0 2 events), documented symptomatic (15.8% 29.9%), nausea (11.2% 1.4%), vomiting (6.7% injection site reactions (9.5% 5.3%).Weekly is simpler therapeutic option than therapy, resulting comparable reduction weight loss lower risk.