Safety and effectiveness of different forms of insulin glargine

This study compared the effectiveness and safety of two forms of insulin glargine in adults with type 2 diabetes (T2D). It was determined that both forms were effective in controlling blood glucose levels, but that the more concentrated form was slightly less likely to cause hypoglycemia (dangerously low blood glucose).

People with T2D can control their symptoms, at first, with lifestyle changes (such as a healthy diet and exercise) and non-insulin medications. However, most people will eventually need insulin to maintain control.

Insulin is the hormone needed to lower blood glucose levels. Basal insulin helps to keep glucose levels steady between meals. Insulin glargine is a slightly altered form of insulin that is designed to provide a steady supply of insulin to the body. Insulin glargine 300 units/ml  (Gla-300) is a more concentrated form of insulin glargine 100 units/ml (Gla-100). Previous research has suggested that Gla-300 might be better than Gla-100 in the long-term control of blood glucose levels.

This study recruited 878 adults with T2D who had used non-insulin drugs in the past, but never used insulin. Half received Gla-300 once a day. The other half received Gla-100 once a day. They continued this treatment for 12 months.

After 12 months the average HbA1c (average blood glucose over 3 months) was 7.13% in the Gla-300 group and 7.24% in the Gla-100 group. From the start to the end of the study HbA1c was reduced by 0.08% more in the Gla-300 group.

The daily basal dose of insulin needed increased in both groups. However, it increased more in the Gla-300 group than the Gla-100 group.

Participants in the Gla-300 group had a 14% lower chance of experiencing hypoglycemia, at least once, at night, during the study than the Gla-100 group. The Gla-300 group had an 8% lower chance of experiencing hypoglycemia, at least once at any time, than the Gla-100 group. Participants with a BMI (measure of weight that takes height into account) of less than 30 kg/m² (i.e. not obese) were 16% less likely to experience hypoglycemia if they used Gla-300 instead of Gla-100. Participants who had had diabetes for at least 10 years were 14% less likely to experience hypoglycemia if they used Gla-300 instead of Gla-100.

23% of the Gla-300 group achieved an HbA1c level less than 7.0%, without experiencing hypoglycemia at night, compared to 19% of the Gla-100 group.

The study concluded that Gla-300 and Gla-100 were mostly equally effective in controlling blood glucose. They also determined that there was a slightly higher risk of hypoglycemia with Gla-100 than with Gla-300.

Sanofi, the manufacturers of insulin glargine, funded this study.

Discuss the use of different forms of insulin glargine with your physician.