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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)

Lookup NU author(s): Emeritus Professor Philip Home


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OBJECTIVETo compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes on basal insulin (>= 42 units/day) plus mealtime insulin.RESEARCH DESIGN AND METHODSEDITION 1 (NCT01499082) was a 6-month, multinational, open-label, parallel-group study. Adults with glycated hemoglobin A(1c) (HbA(1c)) 7.0-10.0% (53-86 mmol/mol) were randomized to Gla-300 or Gla-100 once daily with dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L. Primary end point was HbA(1c) change from baseline; main secondary end point was percentage of participants with one or more confirmed (<= 3.9 mmol/L) or severe nocturnal hypoglycemia from week 9 to month 6.RESULTSParticipants (n = 807) had mean age 60 years, diabetes duration 16 years, BMI 36.6 kg/m(2), and HbA(1c) 8.15% (65.6 mmol/mol). HbA(1c) reduction was equivalent between regimens; least squares mean difference -0.00% (95% CI -0.11 to 0.11) (-0.00 mmol/mol [-1.2 to 1.2]). Fewer participants reported one or more confirmed (<= 3.9 mmol/L) or severe nocturnal hypoglycemic events between week 9 and month 6 with Gla-300 (36 vs. 46% with Gla-100; relative risk 0.79 [95% CI 0.67-0.93]; P < 0.005); nocturnal hypoglycemia incidence and event rates were also lower with Gla-300 in the first 8 weeks of treatment. No between-treatment differences in tolerability or safety were identified.CONCLUSIONSGla-300 controls HbA(1c) as well as Gla-100 for people with type 2 diabetes treated with basal and mealtime insulin but with consistently less risk of nocturnal hypoglycemia.

Publication metadata

Author(s): Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD, Edition 1 Study Investigators

Publication type: Article

Publication status: Published

Journal: Diabetes Care

Year: 2014

Volume: 37

Issue: 10

Pages: 2755-2762

Print publication date: 23/09/2014

Online publication date: 30/07/2014

Acceptance date: 12/06/2014

ISSN (print): 0149-5992

ISSN (electronic): 1935-5548

Publisher: American Diabetes Association


DOI: 10.2337/dc14-0991


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