Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes

Abstract

SummaryIntroductionDegludec (IDeg) is an ultralong-acting insulin, with stable pharmacodynamic profile which leads to lower fluctuations in glucose levels. The effect of IDeg has not been specifically assessed in patients with unstable diabetes, defined as increased glycemic variability (GV).MethodsA prospective before-after pilot study was conducted, including patients managed at Hospital Universitario San Ignacio in Bogotá, Colombia. The impact of the switch from a Glargine or Detemir insulin to a basal insulin regimen with IDeg for 12 weeks on GV measured by continuous glucose monitoring, on A1c levels, and on the incidence of episodes of global and nocturnal hypoglycemia was assessed in a group of patients with (coefficient of variation >34%) or without increased basal GV using a Generalised Estimating Equation (GEE) analysis.Results60 patients with basal bolus therapy and history of hypoglycemia were included. 18 patients had High GV (HGV). In this group a significant reduction of 11.1% of CV (95% CI: 6.3, 15.9, p = 0.01) was found. GEE analysis confirmed a higher impact over time on patients with HGV (p < 0.001). The percentage of patients with at least 1 episode of hypoglycemia decreased from 66.6% to 22.2% (p = 0.02) and from 37.14% to 5.71% (p < 0.01) for global and nocturnal hypoglycemia, respectively. Changes were not significant in patients with low GV. A reduction of A1c was observed in both groups (p < 0.001).ConclusionsThe results suggest that treatment with IDeg reduces GV, A1c levels and the incidence of global and nocturnal hypoglycemia events in patients with HGV, but not in patients with low GV.

The Safety and Efficacy of Second-Generation Basal Insulin Analogues in Adults with Type 2 Diabetes at Risk of Hypoglycemia and Use in Other Special Populations: A Narrative Review

“…Additionally, there was a small, before/after pilot study in a single center in Columbia, involving 60 patients with either unstable type 1 diabetes mellitus (T1DM; 27.6%) or type 2 DM (T2DM; 72.4%) on basal-bolus insulin who had prior hypoglycemia, who switched from a first-generation BI to IDeg for 12 weeks [ 72 ]. Based on the results of a CGM test performed at the first study visit, participants were classified into low ( n = 42) or high glycemic variability ( n = 18), with a coefficient of variation threshold of 34%.…”

Comparison of Second-Generation Basal Insulin Analogs: A Review of the Evidence from Continuous Glucose Monitoring

“…This significant reduction was not observed in the LGV group. 31 It should be noted that people with T1D were a minority in this study (27.6%). Nevertheless, these data suggest that, compared with first-generation basal insulins, IDeg may be of benefit for individuals with high glycemic fluctuations; this may be of clinical importance for individuals with T1D.…”

“…28,30,45 A fourth trial split participants into those with high glycemic variability (HGV) and low glycemic variability (LGV), based on a CV threshold of 34% (similar to the threshold of £36% recommended by the ATTD 2019 consensus group 8 ). 31 In the HGV group, switching from either Gla-100 or IDet to IDeg was associated with a significant reduction in glucose variability at 12 weeks (mean [SD]: baseline, 44.7% [7.3] vs. week 12, 33.6% [10.1]; P < 0.001). This significant reduction was not observed in the LGV group.…”

Favourable effect of the sodium‐glucose co‐transporter‐2 inhibitor canagliflozin plus the dipeptidyl peptidase‐4 inhibitor teneligliptin in combination on glycaemic fluctuation: An open‐label, prospective, randomized, parallel‐group comparison trial (the CALMER study)

“…Details and principles for calculating MAGE and the M‐value are described in Appendix S2. Subjective symptoms and interstitial glucose levels lower than 54 mg/dL for at least 20 min were defined as an episode of clinically significant hypoglycemia . The sample size calculation and statistical analysis methods are described in Appendix S3.…”