Study Finds Significant Differences in Glycemic Control Between Reference and Biosimilar Morning Insulin

In order to investigate the best morning insulin therapy to improve glycemic variability (GV) in patients with type 2 diabetes, researchers from Japan compared morning injections of insulin glulisine and insulin glargine with injections of insulin lispro and insulin glargine biosimilar. The results of the study were presented at The American Diabetes Association 77th Scientific Sessions.

The study enrolled 30 patients with type 2 diabetes, all of whom wore continuous glucose monitoring devices in admission after glucose levels (GL) were stabilized by morning insulins (long-acting and ultra-rapid). The patients were randomized to 2 groups: the first group received morning injections of 300 units per milliliter of the reference treatment, insulin glulisine and insulin glargine, on days 1 and 2 of treatment, followed by the same dose of insulin lispro and insulin glargine biosimilar on days 3 and 4. The second group received the biosimilar for the first 2 days of treatment, followed by the reference treatment on the final 2 days.

The patients received insulin injections at 8:00 am, and test meals were subsequently given. A day was defined as the period from 8:00 am to the following 8:00 am. On days 2 and 4, researches assessed the mean amplitude of glycemic excursion (MAGE) and the mean of daily differences (MODD). The researchers found that increased post-breakfast (PB) GL, PB glucose gradients, mean GL, standard deviation, M- value (12:00 am to 6:00 am), MAGE, and MODD were significantly lower in patients receiving the reference treatment than in the patients receiving the biosimilar treatment:

• PB GL (mg/dL) was 173.5 (range, 160.6 to 192.8) for the reference treatment and 198.0 (range, 165.8 to 217.0) for the biosimilar treatment.
• PB glucose gradient was 0.73 (range, 0.31 to 1.11) for the reference and 1.26 (0.66 to 1.72) for the biosimilar.
• 24-hour mean GL (mg/dL) was 151.0 (range 128.1 to 167.7) for the reference and 153.4 (range, 142.2 to 192.4) for the biosimilar.
• Standard deviation over 24 hours was 33.4 (range, 27.2 to 40.3) for the reference, 33.5 (27.3 to 55.0) for the biosimilar.
• M- value (target glucose level = 100 mg/dL) was 8.4 (range, 4.4 to 22.4) for the reference and 9.7 (range, 6.2 to 31.9) for the biosimilar.
• MAGE (mg/dL) was 47.6 (range, 38.2 to 55.7) for the reference and 53.2 (range, 46.1 to 86.8) for the biosimilar treatment.
• MODD (mg/dL) was 24.6 (range, 16.4 to 31.1) for the reference and 25.2 (range, 19.6 to 39.0) for the biosimilar treatment.

Pre-lunch and pre-breakfast GL were significantly lower in patients receiving the biosimilar treatment than in those receiving the reference. The difference in the highest PB GL between the groups was significantly correlated to 24-hour mean GL (r = 0.4, P = .03).

The researchers concluded that, compared with the biosimilar treatment, the reference treatment decreases PB GL, reducing the rate of rise, nocturnal and 24-hour GV and GL without causing hypoglycemia, and daily variance.