Dataset Information

Efficacy and Safety of Insulin Degludec for Hyperglycemia Management in Noncritical Hospitalized Patients with Diabetes: An Observational Study.

ABSTRACT:

Introduction

To assess the efficacy and safety of insulin degludec administered in a basal-bolus regimen according to the GesTIO protocol in noncritical hospitalized patients with T1DM and T2DM.

Methods

Mean blood glucose levels (BG) and their standard deviations (SD) at admission vs. discharge were compared in 52 subjects (48.1% ≥75 years) managed through a basal-bolus scheme including degludec. The percentages of patients with BG at target (140-180 mg/dl) or below at discharge and the incidence rate (and the 95% confidence interval for it) of hypoglycemia were assessed.

Results

From admission to discharge, fasting BG decreased from 237 to 153 mg/dl (p < 0.0001) and SD dropped from 125 to 38 mg/dl (p < 0.0001); average BG decreased from 189 to 145 mg/dl (SD dropped from 57 to 32 mg/dl). At discharge, 28.9% had BG at target, while 50.0% had lower levels (average 119.0 ± 14.4 mg/dl). The incidence rate of hypoglycemia was 0.07 (0.05; 0.11) episodes per person-day; 1 out of 27 episodes occurred during the night.

Conclusions

Degludec in hospitalized, mainly elderly patients is effective and minimizes glucose variability and nocturnal hypoglycemia.

SUBMITTER: Simioni N

PROVIDER: S-EPMC5544608 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-to-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. METHODS:We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-to-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome. RESULTS:Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, and the mean (±SD) glycated hemoglobin level was 8.4±1.7%; 83.9% of the patients were receiving insulin. The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P<0.001 for noninferiority). At 24 months, the mean glycated hemoglobin level was 7.5±1.2% in each group, whereas the mean fasting plasma glucose level was significantly lower in the degludec group than in the glargine group (128±56 vs. 136±57 mg per deciliter, P<0.001). Prespecified adjudicated severe hypoglycemia occurred in 187 patients (4.9%) in the degludec group and in 252 (6.6%) in the glargine group, for an absolute difference of 1.7 percentage points (rate ratio, 0.60; P<0.001 for superiority; odds ratio, 0.73; P<0.001 for superiority). Rates of adverse events did not differ between the two groups. CONCLUSIONS:Among patients with type 2 diabetes at high risk for cardiovascular events, degludec was noninferior to glargine with respect to the incidence of major cardiovascular events. (Funded by Novo Nordisk and others; DEVOTE ClinicalTrials.gov number, NCT01959529 .).

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