Using Continuous Glucose Monitoring to Measure the Frequency of Low Glucose Values When Using Biphasic Insulin Aspart 30 Compared With Biphasic Human Insulin 30

Abstract

OBJECTIVE -Rapid-acting insulin analogs in basal-bolus regimens can reduce nocturnal hypoglycemia, so it is conceivable that twice-daily biphasic insulin analogs might reduce hypoglycemia in patients with insulin-treated type 2 diabetes. We used a continuous glucose monitoring system (CGMS) and self-reported episodes to investigate differences in the frequency of low glucose values in patients with type 2 diabetes, using either biphasic insulin aspart 30 (BIAsp 30) or biphasic human insulin 30 (BHI 30). RESEARCH DESIGN AND METHODS-This was a double-blind, two-period, crossover trial involving 160 subjects. After 8 weeks' run-in, subjects were randomized to the first of two 16-week treatment periods.RESULTS -No differences in overall incidence of low interstitial glucose (IG) were found. Twenty-four-hour plots of CGMS showed low IG was more frequent at night than during the day and was unrecognized by patients. At night, subjects spent significantly less time (percentage of total CGMS recorded) with IG Ͻ3.5 and Ͻ2.5 mmol/l during BIAsp 30 than during BHI 30 treatment, respectively (Ͻ3.5 mmol/l: 6.36 vs. CONCLUSIONS -Overall rates of low glucose over 24 h were not different but were twice as frequent at night than during the day in individuals with type 2 diabetes. Compared with BHI 30, BIAsp 30 was associated with similar low IG readings over 24 h but with fewer nocturnal episodes and less self-reported nocturnal hypoglycemia.

Biphasic insulin aspart 30/70 (BIAsp 30) in the treatment of type 1 and type 2 diabetes

“…49,51 In these studies, which did not focus on obese individuals, no differences in HbA 1c were found between BIAsp 30 and BHI 30, even after 2 years of therapy. …”

“…For example, in RCTs minor hypoglycemia with BIAsp 30 is generally more frequent, 35,38,40 or at best, similar to that with other insulins. 39,49,51 In the PRESENT observational study, patients previously treated with insulin (with or without OAD combination therapy) reported significantly lower minor hypoglycemia 6 months after switching to BIAsp 30 in routine care (from approximately 9.0 to 2.3 events per patient-year). 62 Similar results were reported in the IMPROVE ™ study.…”

“…Although several trials do report the occurrence of nocturnal hypoglycemia with BIAsp 30 therapy (Liebl et al 44 give an incidence of 7.4% for bid dosing over 6 months), its frequency was lower -and significantly so -in two studies. 34,51 Continuous interstitial glucose monitoring over 24 hours, as well as self-monitoring of blood glucose were used by McNally et al to identify the rate of diurnal and nocturnal hypoglycemia. 51 The results indicated that nocturnal hypoglycemia (or low interstitial glucose, 3.5 mmol/L) went largely undetected by patients, and self-reported nocturnal hypoglycemia was significantly less frequent with BIAsp 30 bid than with BHI 30 bid (1.5 vs 3.8 episodes/patient/year; p = 0.002).…”

AHRQ's Comparative Effectiveness Research on Premixed Insulin Analogues for Adults with Type 2 Diabetes: Understanding and Applying the Systematic Review Findings

“…• Insulin aspart 70/30 versus NPH/regular 70/30-3 parallel-arm trials 31,33,34 and 3 crossover trials [35][36][37] • Insulin lispro 75/25 versus NPH/regular 70/30 or NPH/regular 50/50-9 randomized crossover studies [37][38][39][40][41][42][43][44][45] and 1 retrospective observational study 28 • Insulin lispro 50/50 versus NPH/regular 70/30 or NPH/ regular 50/50-3 randomized crossover studies 38,41,46 and 1 parallel-arm study 47 The studies varied considerably in therapy administration methods, dosing schedules, and duration.…”

Targeting acute hyperglycaemia in clinical practice

“…[27] These include Humalog Mix-25 and Novomix 30 which respectively contain insulin lispro and insulin aspart as the fast acting component. Since both insulins also reduce post prandial glucose they provide a useful and simple option for those clinicians who wish to target post-prandial glucose.…”