New Insulin Glargine Formulation

Chicago-According to a phase 3a study, patients with type 2 diabetes who need basal and mealtime insulin had a similar improvement in glycemic control if they received 300 units/mL of insulin glargine or 100 units/mL of the long-acting human insulin analog. During the trial, similar or lower percentages of patients in the 300 units/mL group had hypoglycemia at any time of the day.

Results were presented at the ADA meeting in a late-breaking poster titled New Insulin Glargine Formulation: Glucose Control and Hypoglycemia in People with Type 2 Diabetes Using Basal and Mealtime Insulin (EDITION I). Sanofi, the marketer of insulin glargine, funded the study.

The FDA approved insulin glargine in a 100 units/mL formulation in 2000. It is administered once daily as a subcutaneous injection and is now commonly used in adults with type 2 diabetes and children and adults with type 1 diabetes. The 300 units/mL formulation, which is not FDA-approved, has demonstrated a flatter, more stable, and prolonged pharmacokinetic and pharmacodynamics profile compared with the 100 units/mL formulation.

In this open-label study, 807 patients from 14 countries were randomized in a 1:1 ratio to receive 100 units/mL or 300 units/mL of insulin glargine once daily in the evening. The basal insulin was titrated for 6 months to achieve a fasting plasma glucose between 80 mg/dL and 100 mg/dL.

At baseline, the groups were well balanced. The mean age was 60 years, the mean body mass index was 36.6 kg/m2, and patients had type 2 diabetes for a mean of 15.8 years and had used basal insulin for a mean of 6.6 years.

After 6 months of treatment, patients in each group had a least squares mean change in hemoglobin A1c levels of 0.06%. Significantly more patients in the 300 units/mL group had a reduction in a severe or confirmed nocturnal hypoglycemic event from month 3 to 6 (P=.0045). Treatment emergent adverse events were found in 56.4% of patients in the 300 units/mL group and 54.2% of patients in the 300 units/mL group, while 1.5% and 1.7% of patients, respectively, had a treatment emergent adverse event that led to study discontinuation.

-Tim Casey