Comparison of the injection-site experience of the starting doses with semaglutide and dulaglutide: A randomized, double-blind trial in healthy subjects.

This double-blind, randomized, single-site, crossover trial compared the injection-site experience with the starting doses of semaglutide and dulaglutide. Healthy subjects (aged 18-75 years; body mass index ≥ 25 kg/m2 ; n = 104) were randomized 1:1, using a pregenerated list, to semaglutide 0.25 mg as the first injection and dulaglutide 0.75 mg as the second injection or vice versa; each was administered using their proprietary pen-injectors, according to instructions for use. The primary endpoint was intensity of injection-site pain, measured using a visual analogue scale (VAS; 0 mm = no pain, 100 mm = unbearable pain). Exploratory endpoints included intensity category, duration and quality of injection-site pain, and comparative assessment of injection-site pain with the two injections. The point estimate of the VAS score for injection-site pain intensity was 11.5 mm with dulaglutide versus 5.6 mm with semaglutide; mean (95% confidence interval) estimated treatment difference 5.9 (3.6; 8.2) mm; p < .0001. Other endpoints corroborated a less painful injection experience with semaglutide versus dulaglutide. Safety was consistent with reported data for the drugs. In conclusion, the injection-site experience with semaglutide was rated as less painful than that with dulaglutide.

Efficacy and safety performance of the Innovo insulin doser.

Innovo (Novo Nordisk A/S, Hillerød, Denmark) is a new insulin injection system that offers built-in memory and a large, clear display to provide patients with more control during insulin injections. The aim of this trial was to compare the efficacy and safety of Innovo and NovoPen 3 (Novo Nordisk A/S) in patients experienced in using insulin injection devices. Participants included 217 adults who had used NovoPen 3 or other durable pen systems for at least 6 months. This multinational, multicenter, open, randomized crossover trial comprised two treatment periods of equal duration (6 or 12 weeks). Efficacy was determined using hemoglobin A1c (HbA1c) and blood glucose concentrations, and safety parameters were the frequency and severity of hypoglycemic events. Daily insulin dose was also recorded. The effect of device type on change in HbA1c was not significant. The adjusted treatment differences between Innovo and NovoPen 3 were 0.088% [confidence interval (CI), -0.031 to 0.208%] and 0.005% (CI, -0.086 to 0.096%) for the German and Dutch/Austrian sites, respectively. Blood glucose profiles were not affected significantly by device type. Treatment differences were 0.04 mmol/L (CI, -0.57 to 0.48 mmol/L) and 0.21 mmol/L (CI, -0.13 to 0.55 mmol/L) for the German and Dutch/Austrian sites, respectively. Innovo and NovoPen 3 did not differ with regard to safety: There were no differences in numbers of various types of adverse events, or in percentage of patients experiencing one or more hypoglycemic event. This study demonstrates that the Innovo insulin doser is as safe and efficacious as NovoPen 3.

Patient perception and use of an insulin injector/glucose monitor combined device.

PURPOSE: This clinical trial assessed patient preference, satisfaction, and use of an insulin injector/glucose monitor combination device versus syringes and a separate glucose monitor. METHODS: In a randomized, multicenter, 2-period crossover study, 15 patients with type 1 diabetes were randomized to use either a combined injector/monitor device or syringes, a vial, and a separate glucose monitor, then switched to the alternate treatment. Efficacy, safety, preference, satisfaction, and actual use (via meter download) of the 2 systems were compared. RESULTS: Most of the patients preferred using the combination device to syringes and a separate meter. Results from the Handling of Delivery Systems questionnaire given at the end of the study indicated that 49% of patients felt they tested their blood glucose more often with the combination device than with a separate meter. A higher frequency of daily monitoring was reported with the combination device in patients overall (approximately 1 more reading per week). However, a large subset of patients (32%) showed substantial increases in their frequency of daily glucose monitoring (an average of 1 additional reading per day). CONCLUSIONS: Use of the combination device was associated with significant improvements in patient treatment satisfaction.