Abstract
BackgroundThis post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM).MethodsA phase 4, randomized, open-label, parallel-arm trial included participants aged 18–75 years with T2DM taking once-daily insulin glargine and stable doses of metformin and/or pioglitazone with glycated hemoglobin (HbA1c) 7.5–10.5 % and fasting plasma glucose ≤121 mg/dL. Participants were randomized 1:1 to receive their stable dose of metformin and/or pioglitazone plus twice-daily LM25 or IGL for 24 weeks. The primary efficacy outcome was change in HbA1c after 24 weeks of treatment. Results from participants in Argentina, Brazil, and Mexico are presented here.Results162 participants (80 LM25; 82 IGL) with mean ± standard deviation (SD) age = 57.3 ± 9.0 years and body mass index = 31.3 ± 5.2 kg/m2 were included. Mean ± SD change in HbA1c from baseline to week 24 was −1.5 ± 1.0 % (LM25) and −1.1 ± 1.2 % (IGL). At week 24, 35.1 % (LM25) and 31.6 % (IGL) of participants achieved HbA1c <7.0 %. Mean ± SD weight gain from baseline to week 24 was 2.4 ± 2.9 kg in the LM25 group and 1.0 ± 3.1 kg in the IGL group. The mean ± SD rates of total hypoglycemia per year were 18.9 ± 27.3 (LM25) and 21.6 ± 31.1 (IGL). Rates of treatment-emergent adverse events were 46 % (LM25) and 39 % (IGL).ConclusionsOur results suggest that both LM25 and IGL are viable treatment options for insulin intensification in Latin American patients with T2DM with suboptimal glycemic control on basal insulin glargine. The safety and tolerability profiles of LM25 and IGL are consistent between this Latin American population and the global trial-level population.Trial registration NCT01175824
Highlights
This post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM)
Study design This study was a post hoc analysis of a subpopulation of Latin American participants from a multinational, randomized, open-label, noninferiority, phase 4 clinical trial designed to examine the efficacy and safety of 2 insulin intensification strategies in patients with T2DM not adequately controlled on once-daily basal insulin glargine with metformin and/or pioglitazone [12]
Our approach is consistent with the Latin American Diabetes Association (ALAD) guidelines for intensifying insulin therapy in patients with glycated hemoglobin (HbA1c) >7.0 % and our results suggest that both LM25 and IGL can be effective for lowering HbA1c in Latin American patients with T2DM who have blood glucose levels not adequately controlled on oral agents and basal insulin
Summary
This post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM). In 2014, the prevalence of T2DM in South and Central America was 8.1 % (24.8 million patients) [2] and is projected to increase by 60 % (to 38.5 million patients) by 2035 [1]. This increase is partly caused by changes in diet and lifestyle, e.g., urbanization, an increase in the consumption of animal products and processed foods, and increases in patient body mass [3,4,5]. The Latin American Diabetes Association (ALAD) guidelines recommend initiating insulin therapy with a long-acting basal insulin analogue, such as insulin glargine, in combination with oral agents for patients who fail to achieve target HbA1c on oral agents alone [3]. Most patients with T2DM will require an intensification of their insulin therapy
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