Julio Rosenstock1, Alice Cheng2, Robert Ritzel3, Zsolt Bosnyak4, Christine Devisme5, Anna M G Cali6, Jochen Sieber7, Peter Stella8, Xiangling Wang9, Juan P Frías10, Ronan Roussel11,12,13, Geremia B Bolli14. 1. Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com. 2. Division of Endocrinology and Metabolism, University of Toronto, Toronto, Canada. 3. Klinikum Schwabing and Klinikum Bogenhausen, Städtisches Klinikum München GmbH, Munich, Germany. 4. Sanofi, Paris, France. 5. AIXIAL, Boulogne-Billancourt, France. 6. Sanofi, Tokyo, Japan. 7. Sanofi, Frankfurt, Germany. 8. Sanofi, Budapest, Hungary. 9. Sanofi, Beijing, China. 10. National Research Institute, Los Angeles, CA. 11. Diabetology Endocrinology Nutrition, Hôpital Bichat, DHU FIRE, Assistance Publique Hôpitaux de Paris, Paris, France. 12. INSERM U-1138, Centre de Recherche des Cordeliers, Paris, France. 13. UFR de Médecine, Université Paris Diderot, Sorbonne Paris Cité, Paris, France. 14. Perugia University Medical School, Perugia, Italy.
Abstract
OBJECTIVE: To compare insulin glargine 300 units/mL (Gla-300) versus insulin degludec 100 units/mL (IDeg-100) in this first head-to-head randomized controlled trial. RESEARCH DESIGN AND METHODS: BRIGHT (NCT02738151) was a multicenter, open-label, active-controlled, two-arm, parallel-group, 24-week, noninferiority study in insulin-naive patients with uncontrolled type 2 diabetes. Participants were randomized 1:1 to evening dosing with Gla-300 (N = 466) or IDeg-100 (N = 463), titrated to fasting self-monitored plasma glucose of 80-100 mg/dL. The primary end point was HbA1c change from baseline to week 24. Safety end points included incidence and event rates of hypoglycemia. RESULTS: At week 24, HbA1c improved similarly from baseline values of 8.7% (72 mmol/mol) in the Gla-300 group and 8.6% (70 mmol/mol) in the IDeg-100 group to 7.0% (53 mmol/mol)-least squares mean difference -0.05% (95% CI -0.15 to 0.05) (-0.6 mmol/mol [-1.7 to 0.6])-demonstrating noninferiority of Gla-300 versus IDeg-100 (P < 0.0001). Hypoglycemia incidence and event rates over 24 weeks were comparable with both insulins, whereas during the active titration period (0-12 weeks) the incidence and rate of anytime (24-h) confirmed hypoglycemia (≤70 and <54 mg/dL) were lower with Gla-300. Both insulins were properly titrated and exhibited no specific safety concerns. CONCLUSIONS: Gla-300 and IDeg-100 provided similar glycemic control improvements with relatively low hypoglycemia risk. Hypoglycemia incidence and rates were comparable with both insulins during the full study period but lower in favor of Gla-300 during the titration period. The choice between these longer-acting basal insulins may be determined by factors such as access and cost, alongside clinical considerations.
RCT Entities:
OBJECTIVE: To compare insulin glargine 300 units/mL (Gla-300) versus insulin degludec 100 units/mL (IDeg-100) in this first head-to-head randomized controlled trial. RESEARCH DESIGN AND METHODS: BRIGHT (NCT02738151) was a multicenter, open-label, active-controlled, two-arm, parallel-group, 24-week, noninferiority study in insulin-naivepatients with uncontrolled type 2 diabetes. Participants were randomized 1:1 to evening dosing with Gla-300 (N = 466) or IDeg-100 (N = 463), titrated to fasting self-monitored plasma glucose of 80-100 mg/dL. The primary end point was HbA1c change from baseline to week 24. Safety end points included incidence and event rates of hypoglycemia. RESULTS: At week 24, HbA1c improved similarly from baseline values of 8.7% (72 mmol/mol) in the Gla-300 group and 8.6% (70 mmol/mol) in the IDeg-100 group to 7.0% (53 mmol/mol)-least squares mean difference -0.05% (95% CI -0.15 to 0.05) (-0.6 mmol/mol [-1.7 to 0.6])-demonstrating noninferiority of Gla-300 versus IDeg-100 (P < 0.0001). Hypoglycemia incidence and event rates over 24 weeks were comparable with both insulins, whereas during the active titration period (0-12 weeks) the incidence and rate of anytime (24-h) confirmed hypoglycemia (≤70 and <54 mg/dL) were lower with Gla-300. Both insulins were properly titrated and exhibited no specific safety concerns. CONCLUSIONS:Gla-300 and IDeg-100 provided similar glycemic control improvements with relatively low hypoglycemia risk. Hypoglycemia incidence and rates were comparable with both insulins during the full study period but lower in favor of Gla-300 during the titration period. The choice between these longer-acting basal insulins may be determined by factors such as access and cost, alongside clinical considerations.
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