Basal insulin therapy in patients with type 2 diabetes mellitus and poor control of glycemia by oral hypoglycemic agents: results of direct comparative study of insulin analogs Lantus and Levemir

Aim.
To compare efficiency of two regimes of basal therapy with human insulin analogs glargin (Lantus) once daily and detemir (Levemir) twicedaily based on their hypoglycemic action (HbA_1c<7%) and the absence of verified symptomatic hypoglycemia.
Materials and methods.
The study included patients aged 40-75 years with DM2 and poor control of glycemia (7%?HbA_1c?10.5%) under stabletherapy with oral hypoglycemic agents (OHA) in the absence of previous insulin therapy. They were randomized (1:1) into two groups one treatedwith glargin (at supper or at bedtime), the other with detemir (at breakfast and before supper). Dose titration continued until the plasma glucose (PG)level of 5.6 mmol/l was reached before breakfast in both groups and before supper (in group 2, detemir). Previous therapy with tiasolidindions waswithdrawn while therapy with secretagogues (sulfonylurea and glinids) was either continued or discontinued at the investigators discretion. Metformintherapy continued at a constant dose throughout the 24 week study period.
Results.
A total of 973 patients were randomized between group 1 (glargin, n=486) and group 2 (detemir, n=487). Mean age of the patients was58.4?8.3 yr, men to women ratio 54.7/45.3%, mean HbA_1c level 8.7?0.9%, duration of DM 9.9?5.8 yr. 130 (27.5%) patients in group 1 and121 (25.6%) in group 2 achieved the primary end point (HbA_1c<7%) in the absence of verified symptomatic hypoglycemia (95% CI [-3.78%, 7.48%]); HbA_1c<7%: 44.1% in group 1 and 47.8% in group 2 (p=0.254);HbA_1c<6.5%: 22.7% in group 2 and 16.5% in group 1 (p=0.017). Mean HbA_1clevel after completion of the study was 7.2?0.9% in group 1 and 7.1?0.9% in group 2. In both groups it was lower than the initial value (-1.46?1.09% and -1.54?1.11%). The intergroup differences were insignificant (p=0.149). Advantages of therapy were equally well-apparent with respectto selected secondary end points.
Conclusion.
Viewed from the pharmacoeconomic standpoint, results of the study show that glargin and detemir are equally efficacious in terms of hypoglycemiceffect and safe in terms of the risk of hypoglycemia but the former analog has some advantage over the latter because it permits to achievethe targeted level of glycemia after single daily injection at a lower dose

pe 2 diabetes mellitus, basal insulin therapy, insulin analogs glargin and detemir, direct comparative study

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