open access

Vol 9, No 2 (2020)
ORIGINAL ARTICLES
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 Mitra, Saswati Ray, Sushma Jayan
DOI: 10.5603/DK.2020.0010
·
Clinical Diabetology 2020;9(2):128-133.

open access

Vol 9, No 2 (2020)
ORIGINAL ARTICLES
Published online: 2020-03-10

Abstract

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.

Abstract

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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Keywords

type 2 diabetes mellitus, insulin analogues, glargine U 300, hypoglycemia, kidney function parameters, HbA1c, fasting blood sugar, post prandial blood sugar

About this article
Title

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

Journal

Clinical Diabetology

Issue

Vol 9, No 2 (2020)

Pages

128-133

Published online

2020-03-10

DOI

10.5603/DK.2020.0010

Bibliographic record

Clinical Diabetology 2020;9(2):128-133.

Keywords

type 2 diabetes mellitus
insulin analogues
glargine U 300
hypoglycemia
kidney function parameters
HbA1c
fasting blood sugar
post prandial blood sugar

Authors

Asis Mitra
Saswati Ray
Sushma Jayan

References (7)
  1. Riddle MC, Bolli GB, Ziemen M, et al. EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014; 37(10): 2755–2762.
  2. Yki-Järvinen H, Bergenstal R, Ziemen M, et al. EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014; 37(12): 3235–3243.
  3. International Diabetes Federation. Brussels, Belgium: IDF; 2017. IDF diabetes atlas — 8th edition. https://idf.org/e-library/welcome.html. Accessed 10 Jun 2018.
  4. American Diabetes Association. 1. Improving Care and Promoting Health in Populations — 2018. Diabetes Care. 2018; 41(Suppl 1): S7–SS12.
  5. Heise T, Mathieu C. Impact of the mode of protraction of basal insulin therapies on their pharmacokinetic and pharmacodynamic properties and resulting clinical outcomes. Diabetes Obes Metab. 2017; 19(1): 3–12.
  6. US Food and Drug Administration. Approvalpackage.https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206538.
  7. K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification. Am J Kidney Dis. 2002; 39: S1–S266.

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