The BRIGHT study (a “head-to-head” comparison of insulin Glargine 300 U/ml and insulin Degludek 100 U/ml): The comments on the more recent analyses of results
Authors:
Emil Martinka
Authors‘ workplace:
Národný endokrinologický a diabetologický ústav, n. o., Ľubochňa
Published in:
Forum Diab 2020; 9(1): 61-67
Category:
Overview
Insulin Glargine 300 U/ml (iGla300) is an effective and safe second-generation basal insulin analogue. In the “head-to-head” BRIGHT study, the comparison with insulin Degludek 100 U/ml (iDeg100) in patients with type 2 diabetes mellitus (T2DM), previously not treated with insulin, led to a comparable modification of glycemic control (HbA1c, fasting glycemia, intraday variability, the proportion of patients who reached the target values HbA1c without occurrence of hypoglycemia, overall occurrence of hypoglycemia, weight gain), however with a lower occurrence of hypoglycemia in the titration phase. Besides that, it has been shown that the lower occurrence of hypoglycemia in the titration phase is also associated with a lower occurrence of hypoglycemia in the subsequent maintenance phase. In the subanalyses, iGla300 led to a more effective modification of HbA1c in the risk groups, specifically in patients aged > 70 and in patients with estimated glomerular filtration (eGF) < 60 ml/min/1.73m2 while the occurrence of hypoglycemia remains the same. This protection is undoubtedly of practical importance for clinical practice, since the lower risk of hypoglycemia in the titration phase is undoubtedly linked to the patient’s greater confidence in the treatment and better adherence, which may encourage them to a more effective titration of basal insulin to achieve the target values of glycemic control. iGla300 also turns out to be an effective and safe insulin for older patients and those with eGF < 60 ml/min/1.73 m2.
Keywords:
insulin Glargine 300 U/ml – BRIGHT study – insulin Degludek 100 U/ml – eGF < 60 ml/min/1.73 m²
Sources
- Becker RH, Dahmen R, Bergmann K et al. New insulin glargine 300 Units/mL provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units mL. Diabetes Care 2015; 38(4): 637–643. Dostupné z DOI: <http://dx.doi.org/10.2337/dc14–0006>.
- de Boer IH, Rue TC, Hall YN et al. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA 2011; 305(24): 2532–2539. Dostupné z DOI: <http://dx.doi.org/10.1001/jama.2011.861>.
- Bolli GB, Riddle MC, Bergenstal RM et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin‐naive people with type 2 diabetes on oral glucose‐lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab 2015; 17(4): 386‐394. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12438>.
- Coll-de-Tuero, Mata-Cases M, Rodriguez-Poncelas A et al. Chronic kidney disease in the type 2 diabetic patients: prevalence and associated variables in a random sample of 2642 patients of a Mediterranean area. BMC Nephrology 2012; 13: 87. Dostupné z DOI: <http://dx.doi.org/10.1186/1471–2369–13–87>.
- Javier Escalada F, Halimi S, Senior PA et al. Glycaemic control and hypoglycaemia benefits with insulin glargine 300 U/mL extend to people with type 2 diabetes and mild‐to‐moderate renal impairment. Diabetes Obes Metab 2018; 20(12): 2860–2868. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.13470>.
- Garber A, King AB, Del Prato S et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379(9825): 1498–1507. Dostupné z DOI: <http://dx.doi.org/10.1016/S0140–6736(12)60205–0>.
- Haluzík M, Tsimikas AP, Bosnyak Z et al. Differences in HbA 1c lowering effect and hypoglycemia risk between Gla 300 and IDeg according to renal function in the BRIGHT Trial. Diabetes 2019; 68(Suppl 1). Dostupné z DOI: <https://doi.org/10.2337/db19–146-OR>.
- Harris S, Berard L, Westerbacka J et al. Early hypoglycemia after initiation of second second-generation basal insulin (BI) analogs : patient haracteristics and clinical outcomes. Poster 1095. ADA 2019. Diabetes 2019; 68(Suppl 1). Dostupné z DOI: <https://doi.org/10.2337/db19–1095-P>.
- Heise T, Nosek L, Bøttcher SG et al. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 2012; 14(10): 944–950. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1463–1326.2012.01638.x>.
- Heise T, Hermanski L, Nosek L et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab 2012; 14(9):859–864. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1463–1326.2012.01627.x>.
- Charbonnel B, Aroda VR, Westerbacka J et al. Differences in HbA1creduction between insulin glargine 300 U/mL (Gla-300) and insulindegludec100 U/mL (IDeg-100) in adults ≥70 years of age with T2DM in the BRIGHT trial. Poster 131-LB. ADA 2019. Diabetes 2019; 68(Suppl 1). Dostupné z DOI: <https://doi.org/10.2337/db19–131-LB>.
- Cheng AY, Rosenstock J, Ritze R et al. Similar Glycemic Control and Less or Comparable Hypoglycemia with Insulin Glargine 300 U/mL (Gla-300) vs. Degludec 100 U/mL (IDeg-100) in Insulin-Naïve T2DM on Antihyperglycemic Drugs ± GLP-1 RAs—The BRIGHT Randomized Study. OR 301. ADA 2018. Diabetes 2018; 67(Suppl 1). Dostupné z DOI: <https://doi.org/10.2337/db18–301-OR>.
- Martinka E. Kardiovaskulárna morbidita a mortalita pacientov s diabetes mellitus 2. typu na Slovensku. Výsledky štúdie NEFRITI II. Dostupné z WWW: <http://lekar.sdia.sk/sdia-lekarske-profesne-zdruzenie-aktuality/170/kardiovaskularna-morbidita-a-mortalita-pacientov-s-diabetes-mellitus-2-typu-na-slovensku-vysledky-studie-nefriti-ii/>.
- Martinka E, Pontuch P. The prevalence of diabetic nephropathy in patients with type 2 diabetes mellitus in Slovakia: the NEFRITI Study. EASD Stockholm, Sweden, 2015. ePoster A1117. Dostupné z WWW: <http://www.easdvirtualmeeting.org/resources/the-prevalence-of-diabetic-nephropathy-in-patients-with-type-2-diabetes-mellitus-in-slovakia-the-nefriti-study--3>.
- Martinka E. CARERA (CArdiovascular and REnal Risk Assessment) Prieskum kardiovaskulárneho rizika u pacientov s diabetes mellitus 2. typu na Slovensku. Dostupné z WWW: <http://lekar.sdia.sk/sdia-lekarske-profesne-zdruzenie-aktuality/33/carera-cardiovascular-and-renal-risk-assessment-prieskum-kardiovaskularneho-rizika-u-pacientov-s-diabetes-mellitus-2-typu-na-slovensku/>.
- Meneghini L, Gill J, Dauchy et al. A Randomized Pragmatic Real-World Clinical Trial Comparing Insulin Glargine 300 U/mL (Gla-300) with Standard of Care First-Generation Basal Insulins (SoC-BIs) in Insulin-Naïve Patients with Type 2 Diabetes: Twelve-Month Analysis of the ACHIEVE Control Study. Poster 87. ADA 2019. Diabetes 2019; 68(Suppl). Dostupné z DOI: <https://doi.org/10.2337/db19–1087-P>.
- Parving H, Lewis J, Ravid M et al. Prevalence and risk factors for microalbuminuria in a referred cohort of type II diabetic patients: a global perspective. Kidney Int 2006; 69(11): 2057–2063. Dostupné z DOI: <https://doi.org/10.2337/db19–1087-P>.
- Pettus J, Roussel R, Liz Zhou F et al. Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs: The Real-World LIGHTNING Study. Diabetes Ther 2019; 10(2): 617–633. Dostupné z DOI: <http://dx.doi.org/10.1007/s13300–019–0568–8>.
- Riddle MC, Bolli GB, Ziemen M et al. 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. Dostupné z DOI: <http://dx.doi.org/10.2337/dc14–0991>.
- Ritzel R, Roussel R, Bolli GB 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 Obes Metab 2015; 17(9): 859‐867. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12485>.
- Rosenstock J, Cheng A, Ritzel R et al. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial Diabetes Care 2018; 41(10): 2147–2154. Dostupné z DOI: <https://doi.org/10.2337/dc18–0559>.
- Roussel R, Frias J, Westerbacka J et al. Reaching ADA glycemic targets without hypoglycemia during titration with Gla-300 and IDeg-100 in T2DM: exploratory analyses from BRIGHT. Poster 1090. ADA 2019. Diabetes 2019; 68(Suppl 1). Dostupné z DOI: <https://doi.org/10.2337/db19–1090-P>.
- Sullivan SD, Bailey TS, Roussel R et al. Clinical outcomes in real-world patients with type 2 diabetes switching from first- to second-generation basal insulin analogues: Comparative effectiveness of insulin glargine 300 units/mL and insulin degludec in the DELIVER D+ cohort study. Diabetes Obes Metab 2018; 20(9): 2148–2158. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.13345>.
- Gerstein HC, Bosch J, Dagenais GR et al. [ORIGIN Trial Investigators]. Basal insulin and cardiovascular and other outcomes in dysglycemia N Engl J Med 2012; 367(4): 319–328. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1203858>.
- Yki‐Jarvinen H, Bergenstal R, Ziemen M et al. 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. Dostupné z DOI: <http://dx.doi.org/10.2337/dc14–0990>.
- Zhou FL et al. Older Adults with Type 2 Diabetes (T2D) Experience Less Hypoglycemia When Switching to Insulin Glargine 300 U/mL (Gla-300) vs Other Basal Insulins (DELIVER 3 Study). Poster 986. ADA 2017. Diabetes 2017; 66(Suppl 1). Dostupné z DOI: <https://diabetes.diabetesjournals.org/search/Poster%252B986-P%252B2017>.
- Zinman B, Philis-Tsimikas A, Cariou B et al. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes. A 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care 2012; 35(12): 2464–2471. Dostupné z DOI: <http://dx.doi.org/10.2337/dc12–120>.
Labels
Diabetology Endocrinology Internal medicineArticle was published in
Forum Diabetologicum
2020 Issue 1
Most read in this issue
- Plant-based diet according to the NFI protocol in patients with type 2 diabetes mellitus: pilot study
- Hypoglycemia and sport
- Education of patients with hypoglycemia
- Insulin pump therapy and hypoglycemia