Table 1.
Data from selected clinical trials involving biphasic insulin analogues in Type 2 diabetes.
| Author | Year published | Description | Results |
|---|---|---|---|
| Raskin et al.26 INITIATE study |
2005 | 28-week, treat-to-target comparison of BIAsp 30 and insulin glargine | 66% reached an HbA1c of lower than 7% with BIAsp 30 versus 40% with glargine, but with more hypoglycaemia in the former group |
| Garber et al.28 1-2-3 study |
2006 | Treatment was intensified to three daily injections at 16-week intervals | HbA1c of <6.5% was achieved in 60% and <7.0% in 77% of patients without major nocturnal hypoglycaemia |
| Liebl et al.30 PREFER study |
2009 | Insulin-naïve patients treated with BIAsp 30 twice daily and a basal-bolus regimen of detemir and aspart | Comparable glycaemic control was achieved in the two groups; hypoglycaemia rates were low and similar |
| Holman et al.;31 4-T Study Group |
2009 | 708 patients with HbA1c >7% on metformin and sulfonylureas were randomised to three groups: biphasic, prandial, and basal insulin injections, then titrated to basal-prandial coverage | Median HbA1c levels were similar at 3 years (biphasic 7.1%, prandial 6.8%, and basal 6.9%) Rates of hypoglycaemia per patient per year were lowest in the basal and higher in the biphasic and prandial groups (1.7, 3.0, and 5.7, respectively) |
| Berntorp et al.32 | 2011 | Initiation of BIAsp 30 in a 1,154-subject cohort of insulin-naïve Swedish subjects in primary care | Treatment was safe and effective; the mean baseline HbA1c was 8.8% and improved to 7.2% after 6 months |
| Riddle et al.36 | 2014 | Twice daily protamine-aspart/aspart insulin regimen compared to basal-bolus in 588 patients for 60 weeks | Full basal-prandial approach was only slightly more efficacious than twice daily biphasic insulin |
| Malek et al.38 | 2015 | 50-week study comparing thrice daily biphasic insulin aspart 30 to a basal-bolus insulin detemir plus aspart in 403 African patients | Results were similar in both groups with respect to HbA1c lowering and rates of hypoglycaemia |
| Jia et al.39 | 2015 | Comparison of thrice daily insulin lispro premix with basal-bolus glargine-lispro regimen therapy in 400 Asian patients in four countries | Both regimens were similar in efficacy (HbA1c reductions of −1.1%) and adverse events; lispro premix was thus non-inferior to basal-bolus therapy |
| Aschner et al.40 | 2015 | 24-week open-label trial of glargine compared with premixes in 923 insulin-naïve patients on oral agents | More patients achieved target HbA1c with premixes (52 versus 43%); symptomatic hypoglycaemia was less with glargine |
| Linjawi et al.;42 Sit2Mix trial |
2015 | Open-label, three-arm, 24-week trial of 582 insulin-naïve patients on metformin randomised to once or twice daily BIAsp 30 with sitagliptin or twice daily BIAsp 30 alone | HbA1c reduction was superior with twice daily BIAsp+sitagliptin versus once daily BIAsp+sitagliptin and twice daily BIAsp (HbA1c values were 6.9%, 7.2%, and 7.1% from a baseline of 8.4%); hypoglycaemia and weight parameters favoured the once daily BIAsp+sitagliptin group |
| Gross et al.43 | 2016 | 24-week, randomised trial of the efficacy and safety of biphasic insulin lispro 75/25 twice daily versus insulin glargine plus once daily lispro in 476 patients | Improvement in glycaemic control with insulin intensification was similar with both regimens; no clear superiority was demonstrated |
BIAsp: biphasic insulin aspart; HbA1c: glycated haemoglobin.