Rationale, Design, and Baseline Data of the Insulin Glargine (Lantus) Versus Insulin Detemir (Levemir) Treat-To-Target (L2T3) Study: A Multinational, Randomized Noninferiority Trial of Basal Insulin Initiation in Type 2 Diabetes

Abstract

Objective: To discuss the design and baseline data of the Lantus^® (sanofi-aventis, Paris, France) versus Levemir^® (Novo Nordisk A/S, Bagsværd, Denmark) Treat-To-Target (L2T3) study, a multinational, randomized comparison between the basal insulin analogs insulin glargine and insulin detemir. Methods: Insulin-naive subjects with type 2 diabetes suboptimally controlled on oral glucose-lowering drugs (OGLDs) (including at least metformin) were randomized to 24-week treatment with either insulin glargine once-daily or insulin detemir twice-daily, titrated to obtain fasting plasma glucose Results: Recruitment was completed in November 2007. The majority of the randomized population (n = 973) was white (77.8%) and used one other OGLD beside metformin (70.7%). Concerning patient-reported outcomes, ∼20% of subjects reported no physical symptoms of fatigue or hyperglycemia before insulin initiation, and ∼10% were maximally satisfied with their previous treatment. One-third of patients (29.9%) reported suboptimal well-being, and 9.3% had a score indicating depression. Better emotional well-being was significantly associated with lower diabetes symptom distress and higher treatment satisfaction (respectively, r = −0.56 and 0.41; P < 0.001). Conclusions: The L2T3 study will extend the evidence on both the efficacy and the effects on quality of life and treatment satisfaction of the long-acting insulin analogs glargine and detemir. Additionally, it will increase our understanding of the factors important to the (self-)management of type 2 diabetes patients starting insulin.