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Diabetic Medicine
Year: 2009  |  Volume: 26  |  Issue: 11  |  Page No.: 1147 - 1155

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

B. H. R. Wolffenbuttel, L. J. Klaff, R. Bhushan, J. L. Fahrbach, H. Jiang and S. Martin    

Abstract: 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 (HbA1c) was similar (LM25 8.7 ± 1.2, glargine 8.8 ± 1.1%, P = 0.612). At 24-weeks, LM25 patients had lower HbA1c (7.0 ± 0.9 vs. 7.3 ± 0.9%, P < 0.001), greater HbA1c reduction (−1.7 ± 1.2 vs. −1.5 ± 1.1%, P < 0.001), and more patients reaching HbA1c < 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 HbA1c and a higher % of patients reaching HbA1c target of < 7.0%, but with more weight gain and higher rates of hypoglycaemia compared to glargine.

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