Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study

Abstract

Context: Observational studies of insulin degludec (degludec) with hypoglycemia events prospectively recorded are lacking.

Objective: To evaluate the safety and effectiveness of degludec in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) switching from other basal insulins in routine care.

Design: Results From Real-World Clinical Treatment With Tresiba® was a multinational, multicenter, prospective, observational, single-arm study comprising a 4-week baseline period (preswitch basal insulin) and 12-month follow-up (degludec).

Setting: Routine clinical practice.

Patients or other participants: Insulin-treated patients (≥18 years) with T1D (n = 556) or T2D (n = 611) with treatment plans to initiate degludec.

Interventions: Switching to degludec from other basal insulins.

Main outcome measure: Change from baseline in number of overall hypoglycemic events recorded in patient diaries.

Results: In T1D, the 12-month follow-up/baseline rate ratios (95% CI) of overall [0.80 (0.74 to 0.88)], nonsevere [0.83 (0.76 to 0.91)], severe [0.28 (0.14 to 0.56)], and nocturnal [0.61 (0.50 to 0.73)] hypoglycemia suggested significantly lower hypoglycemia rates with degludec (all Ps < 0.001). At 12 months, HbA1c, fasting plasma glucose (FPG), and basal insulin dosage decreased significantly. Body weight increased, and treatment satisfaction improved significantly. In T2D, the hypoglycemia rate ratios were overall [0.46 (0.38 to 0.56)], nonsevere [0.53 (0.44 to 0.64)], and nocturnal [0.35 (0.20 to 0.62)] (all Ps < 0.001; too few events for analysis of severe hypoglycemia). At 12 months, HbA1c and FPG decreased significantly. Body weight and insulin dosages remained unchanged, and treatment satisfaction was significantly improved.

Conclusions: In a routine clinical care setting, switching to degludec from other basal insulins was associated with significantly lower rates of hypoglycemia, improved glycemic control, and treatment satisfaction in patients with T1D or T2D.

Trial registration: ClinicalTrials.gov NCT02392117.

Figure 1.

Schematic of trial design. (A) Patient disposition and (B) trial design. Gray arrows indicate 4-wk periods when hypoglycemic episodes will be recorded prospectively in patient diaries. Visits are defined as contact with the treating physician. OD, once daily.

Figure 2.

Patient disposition.

Figure 3.

Hypoglycemia in patients with T1D or T2D during the 12-mo follow-up period vs the 4-wk baseline period. Hypoglycemia was analyzed via a negative binomial regression model controlled for period (pre/post), age, sex, HbA1c, diabetes duration, BMI, and country. For T2D, additional covariates included prandial insulin (yes or no) and sulfonylurea + glinides (yes or no). Total follow-up time (patient-years) for T1D was 38.5 and 104.5 for the 4-wk baseline period and the 12-mo follow-up period, respectively. Total follow-up time (patient-years) for T2D was 40.8 and 118.8 for the 4-wk baseline period and the 12-mo follow-up period, respectively. N/A, severe hypoglycemia could not be analyzed because of the low number of events. E, number of events; N, number of patients; R, number of events per patient-year of exposure.

Figure 4.

Sensitivity analyses in overall hypoglycemia in patients with T1D or T2D during the 12-mo follow-up period vs the 4-wk baseline period. Sensitivity analysis 1 is based on the 26- to 30-d diary period, where the dates of hypoglycemic events recorded on the hypoglycemia page fell within the diary period. Sensitivity analysis 2 is based on all diaries, where the dates of hypoglycemic events recorded on the hypoglycemia page matched the events in the diary exactly. Sensitivity analysis 3 is based on all diaries, where the dates of hypoglycemic events recorded on the hypoglycemia page fell within the diary period. Sensitivity analysis 4 is based on the 26- to 30-d diary period, where the dates of hypoglycemic events recorded on the hypoglycemia page matched the events in the diary exactly for patients with a minimum of 23 diary days for each diary period, who completed 12 mo observation. E, number of events; N, number of patients; R, estimated number of events per patient-year.

Figure 5.

Observed mean (SD) (A) HbA1c and (B) FPG for patients with T1D or T2D after switch to degludec from other basal insulins.

Figure 6.

Observed mean (SD) (A) basal, (B) bolus, and (C) total insulin dose over time in patients with T1D or T2D after switch to degludec from other basal insulins.

Figure 7.

Observed mean (SD) body weight over time in patients with T1D or T2D after switch to degludec from other basal insulins.

Figure 8.

Mean treatment satisfaction in DTSQ-s in patients with (A) T1D or (B) T2D. Asterisks indicate significant differences. Data are changes between the 4-wk baseline period and the 12-mo follow-up period (95% CI). DTSQ-s scores range from 6 (very satisfied) to 0 (very dissatisfied). For the final question regarding perceived frequency of hypoglycemia, this question is treated separately from the other questions, and a low score represents good perceived blood glucose control.

Figure 9.

PROs in SF-36^® v2 for patients with (A) T1D or (B) T2D. Asterisks indicate significant differences. Data are changes between the 4-wk baseline period and the 12-mo follow-up period (95% CI).