Portal de Periódicos da CAPES

The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) Trial

2011; American Diabetes Association; Volume: 34; Issue: 2 Linguagem: Inglês

10.2337/dc10-1701

1935-5548

John B. Buse, Bruce H. R. Wolffenbuttel, William H. Herman, Stephen Hippler, Sherry Martin, Honghua Jiang, Sylvia Shenouda, Jessie L. Fahrbach,

Pancreatic function and diabetes

OBJECTIVE This study compared the durability of glycemic control of twice-daily insulin lispro mix 75/25 (LM75/25: 75% insulin lispro protamine suspension/25% lispro) and once-daily insulin glargine, added to oral antihyperglycemic drugs in type 2 diabetes patients. RESEARCH DESIGN AND METHODS During the initiation phase, patients were randomized to LM75/25 or glargine. After 6 months, patients with A1C ≤7.0% advanced to the maintenance phase for ≤24 months. The primary objective was the between-group comparison of duration of maintaining the A1C goal. RESULTS Of 900 patients receiving LM75/25 and 918 patients receiving glargine who completed initiation, 473 and 419, respectively, had A1C ≤7.0% and continued into maintenance. Baseline characteristics except age were similar in this group. Median time of maintaining the A1C goal was 16.8 months for LM75/25 (95% CI 14.0–19.7) and 14.4 months for glargine (95% CI 13.4–16.8; P = 0.040). A1C goal was maintained in 202 LM75/25-treated patients (43%) and in 147 glargine-treated patients (35%; P = 0.006). No differences were observed in overall, nocturnal, or severe hypoglycemia. LM75/25 patients had higher total daily insulin dose (0.45 ± 0.21 vs. 0.37 ± 0.21 units/kg/day) and more weight gain (5.4 ± 5.8 vs. 3.7 ± 5.6 kg) from baseline. Patients taking LM75/25 and glargine with lower baseline A1C levels were more likely to maintain the A1C goal (P = 0.043 and P < 0.001, respectively). CONCLUSIONS A modestly longer durability of glycemic control was achieved with LM75/25 compared with glargine. Patients with lower baseline A1C levels were more likely to maintain the goal, supporting the concept of earlier insulin initiation.