Efficacy and Safety of Insulin Glargine in Patients With Acute Stroke and Hyperglycemia Receiving Intensive Care: Randomized Controlled Study

Abstract Background: This pilot study compared the basal–bolus regimens of long-acting insulin glargine (IG) and neutral protamine Hagedorn (NPH) insulin in efficacy and safety in acute stroke patients with hyperglycemia receiving intensive care (NCT02607943).Methods: This was a randomized, open-label, clinical trial. Stroke patients who were admitted to the intensive care unit within 72 h of onset and met the inclusion criteria were enrolled. They received either IG or NPH with added short-acting prandial regular insulin over a 72-h period. The primary endpoints were the percentage of glucose within the range of 80 to 180 mg/dL and the percentage of glucose reduction compared with pre-randomization glucose levels, assessed through continuous glucose monitoring (CGM).Results: A total of 50 patients were included, 26 and 24 were randomly assigned to the IG and NPH, respectively. The participant baseline characteristics were comparable between groups, except the IG had a significantly higher glucose level pre-randomization than the NPH (290.69 ± 82.31 versus 246.04 ± 41.76 mg/dL, P = .021). CGM data showed that the percentage of time with glucose levels between 80 and 180 mg/dL was 45.88 ± 27.04% in the IG and 53.56 ± 22.89% in the NPH (P = .341) and the percentage of glucose reduction was 31.47 ± 17.52% in the IG and 27.28 ± 14.56% in the NPH (P = .374). The percentage of time with hypoglycemia (< 60 mg/dl) was 0.14 ± 0.49% in the IG and 0.47 ± 1.74% in the NPH (P = .361). Parameters representative of glucose variabilities, and poststroke outcomes were not significantly different between the groups.Conclusions: Our study results suggest that early initiation of an IG-based basal–bolus regimen is safe and equally effective as an NPH-based basal-bolus regimen for patients with acute stroke and hyperglycemia requiring intensive care.Trial registration: ClinicalTrials.gov, NCT02607943. Registered 18 Nov 2015, https://clinicaltrials.gov/ct2/show/NCT02607943