Clinical Data
MK-1293 in Patients with Type 1 Diabetes (296-OR)The Phase 3, randomized, active-controlled, open-label trial assessed the efficacy and safety of MK-1293 (n= 245) compared with Lantus (n=263) in patients with type 1 diabetes. The primary efficacy endpoint was non-inferiority of change from baseline A1C at week 24. At baseline, patients had an A1C level equal to or less than 11.0 percent and were taking basal and prandial insulin.The primary endpoint of the study was met, demonstrating the non-inferiority of MK-1293 to Lantus in patients with type 1 diabetes. The least-squares mean difference in A1C (MK-1293 minus Lantus) was 0.04 percent (95% CI: -0.11, 0.19), meeting A1C non-inferiority (upper bound of the confidence interval <0.4%) and equivalence (confidence interval within -0.4% and 0.4%) criteria. Basal insulin doses were similar between groups (MK-1293 minus Lantus; difference of -0.7 U/day; 95% CI -2.5, 1.0 U/day).The primary safety objective was anti-insulin antibody (AIA) development. Similar AIA, including incidence and titers, and similar neutralizing antibody responses were seen between treatment groups. The study found that 74 percent of patients receiving Lantus and 70 percent receiving MK-1293, irrespective of AIA status at baseline, had an AIA positive result at or before week 24. Additionally, 36 percent of patients receiving Lantus and 33 percent of patients receiving MK-1293 who were negative for AIA at baseline had an AIA positive result at or before week 24.No clinically meaningful difference in safety endpoints of interest were seen between treatment groups. In this study, 76.4 percent of patients receiving Lantus and 71.0 percent of patients receiving MK-1293 experienced symptomatic hypoglycemia. In addition, 0.4 percent of patients receiving Lantus and 0.8 percent of patients receiving MK-1293 experienced an injection site reaction; 0.4 percent of patients receiving MK-1293 and none taking Lantus experienced a systemic allergic reaction; 1.9 percent of patients receiving Lantus and 0.4 percent of patients receiving MK-1293 experienced angioedema or a severe cutaneous adverse reaction. There were no reports of anaphylactic response in either treatment group.MK-1293 in Patients with Type 2 Diabetes (926-P)The Phase 3, randomized, active-controlled, open-label trial assessed the efficacy and safety of MK-1293 (n=265) compared to Lantus (n=266) in patients with type 2 diabetes inadequately controlled on diet and exercise alone. The primary efficacy endpoint was non-inferiority of change from baseline A1C at week 24. At baseline, patients had an A1C level equal to or less than 11.0 percent and were eligible for or were taking basal insulin greater than or equal to 10 U/day.MK-1293 met the study’s primary endpoint, demonstrating non-inferiority to Lantus with a least-squares mean difference in A1C (MK-1293 minus Lantus) of 0.03 percent (95% CI: -0.12, 0.18), meeting A1C non-inferiority (upper bound of the confidence interval <0.4%) and equivalence (confidence interval within -0.4% and 0.4%) criteria. Basal insulin doses were similar between groups (MK-1293 minus Lantus; difference of 1.4 U/day; 95% CI -2.2, 4.9 U/day).The primary safety objective was anti-insulin antibody (AIA) development. Similar AIA, including incidence and titers, and similar neutralizing antibody responses were seen between treatment groups. In the study, 29.0 percent of patients receiving Lantus and 34.7 percent being treated with MK-1293, irrespective of AIA status at baseline, had an AIA positive at or before week 24. Additionally, 14.9 percent of patients receiving Lantus and 19.3 percent of patients receiving MK-1293 who were negative of AIA at baseline had an AIA positive at or before week 24.No clinically meaningful between-group differences were found for pre-defined safety endpoints of interest. Symptomatic hypoglycemia was observed in 52.1 percent of patients receiving Lantus and 53.2 percent of patients receiving MK-1293. In the study, 0.4 percent of patients receiving Lantus and 1.9 percent of patients receiving MK-1293 experienced an injection site reaction; 0.4 percent of patients receiving MK-1293 and none taking Lantus experienced a systemic allergic reaction; 0.4 percent of patients receiving MK-1293 and none taking Lantus experienced an anaphylactic response; and 1.1 percent of patients receiving Lantus and 0.4 percent of patients receiving MK-1293 experienced angioedema or severe cutaneous adverse reaction.