Vol 9, No 2 (2020)
Research paper
Published online: 2020-03-10

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The effect of low dose glargine U 300 on uncontrolled type 2 diabetes mellitus. An observational study in Indian patients

Asis Mitra1, Saswati Ray2, Sushma Jayan3
Clin Diabetol 2020;9(2):128-133.


Introduction. Insulin therapy plays an important role in the management of diabetes mellitus. The primary goal of insulin therapy is to achieve the best possible glycemic control without hypoglycemia. First-generation basal insulin (BI) analogues, such as insulin glargine 100 U/mL (Gla-100) and insulin detemir (IDet), provide more prolonged and stable activity than neutral protamine Hagedorn (NPH) insulin, with a lower risk of hypoglycemia. Insulin glargine 300 U/mL (glargine U 300) is a long acting basal insulin analogue approved for the treatment of diabetes mellitus. Insulin glargine 300 U/mL has a more stable and prolonged pharmacokinetic/pharmacodynamics profile than insulin glargine 100 U/mL, with a duration of glucose-lowering activity exceeding 24 h. Although the average daily insulin dose was higher, hypoglycemia episodes were lower in patients treated with Gla-300 compared with those treated with Gla-100. This is due to a more extended time action profile than Gla-100 resulting in a more stable and sustained glycemic control. The formulation of Gla-100 delivers the same amount of Insulin as Gla-300, in a third of the injection volume. It is essential to determine whether the clinical benefits of hypoglycemia reduction observed with insulin glargine in RCTs translate into a real-life clinical practice setting.

Materials and methods. Fifty patients diagnosed with type 2 diabetes mellitus with uncontrolled plasma glucose levels (HbA1c of > 7.5) who were on oral hypoglycemic agents, premix insulin and basal bolus therapy were enrolled into the study and started on glargine U 300 at a dose of 0.2 IU/kg and analysed for glycemic and kidney function parameters. The patients were followed up at 3 and 6 months post treatment.

Results. All glycemic control parameters decreased significantly with almost a 50% decline in both FBS and PBS from baseline to 6 months. The HbA1c decreased significantly from baseline to 3 months and 6 months post treatment by 18% and 29% respectively. All biochemical parameters were found to be statistically significant in both groups.

Conclusions. In patients with uncontrolled type 2 diabetes, switching from either OHAs or insulin to Gla-300 improves glycemic control, with a low incidence of hypoglycemia. These results confirm the effectiveness and safety of Gla-300 in a real-world setting and show that Gla-300 is a suitable therapy option for patients with diabetes.

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