Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials

Christopher Sorli, Mark Warren, David Oyer, Henriette Mersebach, Thue Johansen, Stephen C L Gough, Christopher Sorli, Mark Warren, David Oyer, Henriette Mersebach, Thue Johansen, Stephen C L Gough

Abstract

Background and objective: Elderly patients with diabetes are more vulnerable to the occurrence and effects of hypoglycaemia; therefore, treatments with low risk of hypoglycaemia are preferred in this population. This study aimed to compare hypoglycaemia rates between insulin degludec (IDeg) and insulin glargine (IGlar) in elderly patients.

Methods: Hypoglycaemia data from patients ≥65 years of age with type 1 (T1DM) or type 2 (T2DM) diabetes from seven randomised, treat-to-target phase IIIa trials were used to compare IDeg and IGlar in a pre-planned meta-analysis. Overall, 917/4345 (21 %) randomised patients in the seven trials were elderly (634 IDeg, 283 IGlar). Overall confirmed hypoglycaemia was defined as <3.1 mmol/L or severe hypoglycaemia (symptoms requiring external assistance). Nocturnal hypoglycaemia included confirmed episodes from 0001 to 0559 hours (inclusive). Treatment comparisons of hypoglycaemia in T1DM patients were not performed due to low numbers of elderly patients with T1DM randomised (43 IDeg, 18 IGlar); statistical comparisons were also not made for severe hypoglycaemia due to the low number of events.

Results: In elderly patients with T2DM, the rate of overall confirmed hypoglycaemia was significantly lower with IDeg than IGlar [estimated rate ratio (ERR) 0.76 (0.61; 0.95)95 % CI]; nocturnal confirmed hypoglycaemia was also significantly lower with IDeg [ERR 0.64 (0.43; 0.95)95 % CI]. Confirmed hypoglycaemia occurred in the majority of T1DM patients, whereas severe episodes occurred infrequently and at similar rates in both treatment groups in T1DM and T2DM.

Conclusion: Results of this pre-planned meta-analysis in elderly patients with diabetes demonstrate a significant reduction in hypoglycaemic events with IDeg relative to IGlar.

Figures

Fig. 1
Fig. 1
Disposition of elderly patients (≥65 years of age). AEs adverse events, FAS full analysis set, IDeg insulin degludec, IGlar insulin glargine, SAS safety analysis set, T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus. The IDeg flexible arm is excluded from Trials 3770 and 3668. *Two randomised IDeg patients from one closed trial site were excluded from the full analysis set before the trial was unmasked
Fig. 2
Fig. 2
Estimated rate ratios (IDeg/IGlar) with 95 % confidence intervals in elderly patients ≥65 years of age with T2DM for a overall confirmed hypoglycaemic episodes, and b nocturnal confirmed hypoglycaemic episodes during the total treatment period and maintenance period. *Statistically significant, p < 0.05. IDeg insulin degludec, IGlar insulin glargine, T2DM type 2 diabetes mellitus. Nocturnal confirmed episodes are the subset of overall confirmed hypoglycaemic episodes with onset from 0001 to 0559 hours (both inclusive). The maintenance period was from week 16 to the end of the trials. Full analysis set
Fig. 3
Fig. 3
Estimated rate ratios (IDeg/IGlar) with 95 % confidence intervals in elderly patients ≥65 years of age for the pooled population (T1DM + T2DM) for a overall confirmed hypoglycaemic episodes, and b nocturnal confirmed hypoglycaemic episodes during the total treatment period and maintenance period. *Statistically significant, p < 0.05. IDeg insulin degludec, IGlar insulin glargine, T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus. Nocturnal confirmed episodes are the subset of overall confirmed hypoglycaemic episodes with onset from 0001 to 0559 hours (both inclusive). The maintenance period was from week 16 to the end of the trials. Full analysis set

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