Abstract

Aims: To assess the requirement for insulin glargine 300 U/mL (Gla-300) in people with Type 1 diabetes mellitus (Type 1 DM) previously treated with glargine 100 U/mL (Gla-100), depending on the prior number of daily injections of insulin. The secondary goal is to observe the differences in HbA1c and hypoglycaemia after 6 months of treatment with Gla-300.

Methods: Cross-sectional observational study of people with type 1 DM treated with basal-bolus therapy. Group 1: participants treated with a single dose of insulin Gla-100. Group 2: participants treated with two doses a day. Following medical criteria, all subjects were switched to insulin Gla-300.

Results: 133 participants with type 1 DM: 73 in Group 1 and 60 in Group 2. The participants in Group 2 required a significantly higher dose of basal insulin than those in Group 1, both on a baseline level and at 6 months. No differences in mealtime insulin were observed. There was a significantly increase in insulin dose of Gla-300 than previous doses of Gla-100 in both groups: 18.2% in Group 1 vs 6.4% in Group 2 (p < 0.001). No changes in HbA1c were observed in the two groups at 6 months of treatment and there was a significant reduction in hypoglycaemia in Group 1 (6 vs 4 per month).

Conclusion: Group 2 participants needed a lower increase in their dose of insulin on switching to Gla-300 than subjects in Group 1. The subjects in Group 1 presented less hypoglycaemia after switching treatment, without changes in HbA1c levels.

Keywords: Type 1 Diabetes; Insulin Glargine; Basal-Bolus Therapy; Hypoglycaemia

References

1. Lepore M., et al. “Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultra lente human insulin and continuous subcutaneous infusion of lispro”. Diabetes 49 (2000): 2142-2148.
2. Ashwell SG., et al. “Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart”. Diabetic Medicine 23 (2006): 879-886.
3. Albright ES., et al. “Efficacy of conversion from bedtime NPH insulin injection to once- or twice-daily injections of insulin glargine in type 1 diabetic patients using basal/bolus therapy”. Diabetes Care 27 (2004): 632-633.
4. Clement S and Bowen-Wrigt H. “Twenty-four-hour action of insulin glargine (Lantus) may be too short for once-daily dosing: A case report”. Diabetes Care 25 (2002): 1479-1480.
5. Becker RH., et al. “New insulin glargine 300 units. mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units.mL-1”. Diabetes Care 38 (2015): 637-643.
6. Home PD., et al. “New insulin glargine 100 Units/mL in people with type 1 diabetes: A randomized, phase 3a, open-label clinical trial (EDITION 4)”. Diabetes Care 38 (2015): 2217-2225.
7. Matsuhisa M., et al. “New insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1)”. Diabetes, Obesity and Metabolism 18 (2016): 375-383.
8. Heinemann L., et al. “Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo”. Diabetes 23 (2000): 644-649.
9. Gradiser M., et al. “Changes in HbA1c and hypoglycemic episodis in type 1 diabetes patients after switching to insulin glargine 300: Pilot study”. Diabetes Research and Clinical Practice 129 (2017): 144-147.
10. Pang T., et al. “A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA)”. Diabetic Medicine 36 (2019): 110-119.
11. Pujante-Alarcón P., et al. “Experience after switching from insulin glargine U100 to glargine U300 in patients with type 1 diabetes mellitus. A study after one year of treatment in real life”. Endocrinología, Diabetes y Nutrición 66 (2019): 210-216.
12. Oriot P. “Outcomes of glycemic control in type 1 diabetic patients switched from basal insulin glargine 100 U/mL to glargine 300 U/mL in real life”. Expert Review of Endocrinology and Metabolism 13 (2018): 167-171.
13. Ritzel R., et al. “Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes”. Diabetes, Obesity and Metabolism 17 (2015): 859-867.
14. De Galan BE. “Insulin glargine 300 U/mL in the management of diabetes: clinical utility and patient perspectives”. Patient Preference and Adherence 10 (2016): 2097-2106.