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.
Rode Kruis Ziekenhuis Beverwijk, Beverwijk, The Netherlands. msnvk@rkz.nl
Niek K
NK
Valk
Gerhard
G
Cerny
Jochen
J
Sieber
Lene
L
Lytzen
Birgitte
B
Berg
D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems / Q000009:adverse effects / Q000592:standards*; D008297:Male; D008875:Middle Aged
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin