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.
OBJECTIVE
To discuss the design and baseline data of the Lantus (sanofi-aventis, Paris, France) versus Levemir (Novo Nordisk A/S, Bagsvaerd, 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 <100 mg/dL. The primary outcome was the percentage of subjects reaching hemoglobin A1c (HbA1c) <7% without symptomatic confirmed hypoglycemia. Important secondary outcomes were quality of life and treatment satisfaction, which were repeatedly assessed using validated questionnaires. Also, biomedical and psychological determinants of failure to reach HbA1c <7% were explored.


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, approximately 20% of subjects reported no physical symptoms of fatigue or hyperglycemia before insulin initiation, and approximately 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.
Swinnen
Sanne G H A
SG
Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands. s.g.swinnen@amc.uva.nl
Snoek
Frank J
FJ
Dain
Marie-Paule
MP
DeVries
J Hans
JH
Hoekstra
Joost B L
JB
Holleman
Frits
F
D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin