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Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose‐lowering agents
Author(s) -
Wolffenbuttel B. H. R.,
Klaff L. J.,
Bhushan R.,
Fahrbach J. L.,
Jiang H.,
Martin S.
Publication year - 2009
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2009.02824.x
Subject(s) - medicine , insulin lispro , insulin glargine , type 2 diabetes , diabetes mellitus , glycated hemoglobin , subgroup analysis , insulin , gastroenterology , endocrinology , confidence interval
Aims To compare starter insulins in the elderly subgroup of the DURABLE trial 24‐week initiation phase. Methods In a post‐hoc analysis of the ≥ 65 years subgroup enrolled in the DURABLE trial, we compared the safety and efficacy of lispro mix 25 (LM25: lispro 25%/insulin lispro protamine suspension 75%), n = 258, vs. glargine, n = 222, added to oral glucose‐lowering agents. Results Baseline glycated hemoglobin (HbA 1c ) was similar (LM25 8.7 ± 1.2, glargine 8.8 ± 1.1%, P = 0.612). At 24‐weeks, LM25 patients had lower HbA 1c (7.0 ± 0.9 vs. 7.3 ± 0.9%, P < 0.001), greater HbA 1c reduction (−1.7 ± 1.2 vs. −1.5 ± 1.1%, P < 0.001), and more patients reaching HbA 1c < 7.0% (55.6 vs. 41.0%, P = 0.005). LM25 patients were on more insulin (0.40 ± 0.19 vs. 0.33 ± 0.19 u/kg/day, P < 0.001) and experienced more weight gain (3.6 ± 3.6 vs. 1.8 ± 3.2 kg, P < 0.001). Additionally, LM25‐treated patients reported a higher mean overall hypoglycaemia rate than glargine patients (40.8 ± 47.6 vs. 31.1 ± 48.5 episodes/patient/year, P = 0.037), while nocturnal hypoglycaemia rates were similar. Over 24 weeks, incidence of severe hypoglycaemia was higher for LM25 (4.3% vs. 0.9%, P = 0.018); however, by 24‐week endpoint incidence was similar (0.8% vs. 0.0% P = 0.125). Conclusions In this elderly subgroup post‐hoc analysis, LM25 demonstrated a lower endpoint HbA 1c and a higher % of patients reaching HbA 1c target of < 7.0%, but with more weight gain and higher rates of hypoglycaemia compared to glargine.