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DURABLE trial: Twice-daily insulin lispro mix improved glycemic control

Buse JB. Diabetes Care. 2011;34:249-255.

Issue: April 2011

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New data from the DURABLE trial support the concept of earlier insulin initiation. Compared with insulin glargine, patients with type 2 diabetes achieved modestly longer maintenance of target HbA1c levels with twice-daily insulin lispro mix 75/25, with no difference in hypoglycemia or weight gain.

As part of the manufacturer-sponsored Durability of Basal vs. Lispro mix 75/25 (DURABLE) trial, researchers randomly assigned 900 patients to receive insulin lispro mix 75/25 (Humalog Mix 75/25; Eli Lilly) and 918 patients to insulin glargine (Lantus, Sanofi Aventis). After a 6-month initiation period, 473 patients in the insulin lispro mix 75/25 group and 419 in the insulin glargine group achieved a target HbA1c level of 7% or lower. These patients were followed for 24 months to assess maintenance.

Results revealed that 43% of patients assigned to insulin lispro mix 75/25 and 35% assigned to insulin glargine maintained the HbA1c goal throughout the study period. On average, patients in the insulin lispro mix 75/25 group maintained the target HbA1c level for 16.8 months vs. 14.4 months in the insulin glargine group (95% CI, 13.4-16.8). In both groups, patients with lower baseline HbA1c levels were more likely to maintain the HbA1c goal throughout the study, the researchers said.

According to other results, patients in the insulin lispro mix 75/25 group gained more weight than those in the insulin glargine arm (5.4 kg vs. 3.7 kg). However the researchers noted that weight gain between groups remained similar during the 24-month follow-up (1.6 kg vs. 1.8 kg, respectively). At 0.45 units/kg, the total daily insulin dose for the insulin lispro mix 75/25 group was higher at 30 months when compared with the insulin glargine group (0.37 unit/kg).

No differences were observed between groups in nocturnal or severe hypoglycemia.

Disclosure: The DURABLE trial was funded by Lilly USA, LLC.

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