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Glucodynamics of long‐acting basal insulin peglispro compared with insulin glargine at steady state in patients with type 1 diabetes: substudy of a randomized crossover trial
Author(s) -
Morrow L. A.,
Hompesch M.,
Jacober S. J.,
Leng Choi S.,
Qu Y.,
Sinha V. P.
Publication year - 2016
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12691
Subject(s) - insulin glargine , medicine , crossover study , type 2 diabetes , basal (medicine) , endocrinology , morning , insulin , diabetes mellitus , glycated hemoglobin , basal insulin , randomized controlled trial , placebo , alternative medicine , pathology
Aims To compare, in an open‐label, randomized, crossover phase II substudy, the glucodynamics of insulin glargine and those of basal insulin peglispro ( BIL ) in patients with type 1 diabetes. Methods Patients (n = 23) underwent 24‐h euglycaemic clamps after 8 weeks of treatment with glargine or with BIL . Clinically‐titrated basal insulin doses ( BIL group 16–64 U ; glargine group 19–60 U ) were administered on the morning of the clamp. Results At baseline, the patients' mean ± standard deviation (s.d.) body mass index was 26.78 ± 4.20 kg/m 2 and glycated haemoglobin was 7.69 ± 0.99%. The mean ± s.d. endpoint dose for the BIL group was 0.42 ± 0.13 U /kg and for the glargine group was 0.42 ± 0.10. The daily mean ± s.d. blood glucose concentration was 7.7 ± 1.2 in the BIL group and 7.9 ± 1.2 mmol/l in the glargine group (p = 0.641). The mean ± s.d. total and nocturnal hypoglycaemia rates/30 days were 2.7 ± 2.3 and 0.5 ± 0.8, respectively, for the BIL group, and 3.0 ± 2.4 and 0.7 ± 1.1, respectively, for the glargine group (p = 0.112 and 0.428). The mean glucose infusion rate ( GIR ) normalized to insulin unit was lower for BIL than for glargine. One patient in the glargine group and eight patients in the BIL group had minimal (<0.8 g/kg) GIRs over 24 h. The mean ± s.d. total glucose infused over 24 h ( G TOT (0–24) ) was 1.22 ± 0.82 g/kg in the BIL group and 1.90 ± 1.01 g/kg in the glargine group (p = 0.002). The mean ± s.d. total glucose infused during hours 0–6 ( G TOT (0–6) ) was 0.21 ± 0.22 in the BIL group and 0.41 ± 0.22 g/kg in the glargine group (p < 0.001), while the mean total glucose infused during hours 18–24 ( G TOT (18–24) ) in the BIL group was 0.28 ± 0.18 g/kg and in the glargine group was 0.35 ± 0.23 g/kg (p = 0.198). The peak‐to‐trough ratio was 1.41 for BIL versus 2.22 for glargine. Conclusions BIL has a flatter profile than glargine, with potentially more stable metabolic control. The lower G TOT (0–24) observed in the BIL group is consistent with BIL 's reduced peripheral action.