Table 2.
Clinical trials comparing ILPS with other basal insulin analogs in adult patients with diabetes
| Trial | Treatment (N analyzed) | Mean (SD) baseline HbA1c, % | Clinical endpoints at study end | Conclusions | ||
|---|---|---|---|---|---|---|
| Mean (SD) change in HbA1c, % units | Patients with HbA1c <7.0%, % patients | Overall hypoglycemia incidence, % patients | ||||
| Type 1 diabetes | ||||||
| Chacra et al. [73] | ILPS bid + IL tid × 32 weeks (192) | 8.9 (1.3) | −0.69 (0.07)a | 15 | 90.1 | Glycemic control and incidence of overall and nocturnal hypoglycemia similar with ILPS bid and ID bid |
| ID bid + IL tid × 32 weeks (189) | 8.6 (1.3) | −0.59 (0.07)a | 15 | 91.5 | ||
| Type 2 diabetesb | ||||||
| Arakaki et al. [74] | ILPS od + exenatide bid × 24 weeks (171) | 8.2 (0.8) | −1.16 (0.84) | 53.7 | 70.6 | Glycemic control non-inferior with ILPS od compared with IG od; incidence of overall hypoglycemia similar between treatments |
| IG od + exenatide bid × 24 weeks (168) | 8.2 (0.8) | −1.40 (0.97) | 61.7 | 74.9 | ||
| Esposito et al. [75] | ILPS od × 36 weeks (55) | 8.8 (0.7) | −1.83 (−0.78 to −2.65)c | 62 | 74.5 | Glycemic control and incidence of overall and nocturnal hypoglycemia similar with ILPS od and IG od |
| IG od × 36 weeks (55) | 8.7 (0.7) | −1.89 (−0.80 to −2.70)c | 65 | 67.3 | ||
| Fogelfeld et al. [76] | ILPS od-bid × 24 weeks (219) | 8.8 (0.7) | −1.47 (1.01) | 34.9 | 68.9 | Glycemic control better with ILPS od-bid than ID od-bid (P = 0.03) and with ILPS bid than ID bid (P < 0.001) but similar between ILPS od and ID od; incidence of overall hypoglycemia similar for ILPS od-bid and ID od-bid, ILPS od and ID od, and ILPS bid and ID bid; incidence of nocturnal hypoglycemia higher for ILPS od-bid than ID od-bid (P < 0.01) and ILPS bid than ID bid (P < 0.01), similar for ILPS od and ID od |
| ID od-bid × 24 weeks (210) | 8.8 (0.7) | −1.24 (1.11) | 31.2 | 65.2 | ||
| Koivisto et al. [77] | ILPS od + IL bid-tid × 24 weeks (179) | 8.8 (0.9) | −1.05 (−1.05) | 22 | 56.1 | Glycemic control non-inferior with ILPS od compared with IG od (as bb regimens); no statistically significant or clinically relevant differences in overall or nocturnal hypoglycemia |
| IG od + IL bid-tid × 24 weeks (180) | 8.8 (0.9) | −1.20 (−1.16) | 29 | 63.6 | ||
| Strojek et al. [78] | ILPS od-bid × 24 weeks (235) | 8.7 (0.7) | −1.46 (0.07) | 43.8 | 73.4 | Glycemic control and overall incidence of hypoglycemia similar for ILPS od-bid, ILPS od and ILPS bid versus IG od-bid; incidence of nocturnal hypoglycemia higher for ILPS od-bid and ILPS bid than IG od–bid (P < 0.001 for both), similar for ILPS od and IG od-bid |
| IG od-bid × 24 weeks (236) | 8.7 (0.7) | −1.41 (0.07) | 41.2 | 69.9 | ||
All trials were randomized, open-label, and parallel-group in design
bb basal–bolus, bid twice daily, HbA1c glycated hemoglobin, ID insulin detemir, IG insulin glargine, IL insulin lispro, od once daily, ILPS insulin lispro protamine suspension, SD standard deviation, tid three times daily
aLeast squares mean (standard error) change from baseline
bIn all patients with type 2 diabetes, insulin was added to ongoing oral antidiabetes medications
cMean (95% confidence interval)