Sustained glycaemic control and less nocturnal hypoglycaemia with insulin glargine 300U/mL compared with glargine 100U/mL in Japanese adults with type 1 diabetes (EDITION JP 1 randomised 12-month trial including 6-month extension).
OBJECTIVE
To evaluate the efficacy and safety of insulin glargine 300U/mL (Gla-300) versus glargine 100U/mL (Gla-100) in adults with type 1 diabetes in Japan over 12months.


METHODS
EDITION JP 1 was a multicentre, randomised, open-label phase 3 study. Following a 6-month on-treatment period, participants continued to receive Gla-300 or Gla-100 once daily, plus mealtime insulin, over a 6-month open-label extension phase. HbA1c, hypoglycaemia, body weight and adverse events were assessed.


RESULTS
Overall, 114/122 (93%) and 114/121 (94%) of participants in the Gla-300 and Gla-100 group, respectively, completed the 6-month extension phase. Glycaemic control was sustained in both groups up to month 12 (mean HbA1c: Gla-300, 7.9% [62mmol/mol]; Gla-100, 7.8% [62mmol/mol]). Annualised rates of hypoglycaemia were lower with Gla-300 versus Gla-100; significantly for nocturnal confirmed (<3.0mmol/L [<54mg/dL]) or severe hypoglycaemia (2.39 and 3.85 events per participant-year; rate ratio: 0.62 [0.39-0.97]). No between-treatment differences in mean body weight change or adverse events were observed.


CONCLUSIONS
Over 12months' treatment, participants with type 1 diabetes receiving Gla-300 achieved sustained glycaemic control and experienced less nocturnal hypoglycaemia that was confirmed (<3.0mmol/L [<54mg/dL]) or severe compared with Gla-100, supporting the 6-month results.
Tokushima University, Tokushima, Japan. Electronic address: matuhisa@tokushima-u.ac.jp.
Munehide
M
Matsuhisa
Sanofi, Tokyo, Japan.
Masayoshi
M
Koyama
Sanofi, Beijing, China.
Xi
X
Cheng
Sanofi, Tokyo, Japan.
Mariko
M
Sumi
Oregon Health & Science University, Portland, OR, USA.
Matthew C
MC
Riddle
Perugia University Medical School, Perugia, Italy.
Geremia B
GB
Bolli
Toho University School of Medicine, Tokyo, Japan.
Takahisa
T
Hirose
D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced*; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D000069036:Insulin Glargine / Q000008:administration & dosage*; D049528:Insulin, Long-Acting / Q000008:administration & dosage*; D007564:Japan; D008297:Male; D008875:Middle Aged; D013997:Time Factors
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting
Glycaemic control; Hypoglycaemia; Insulin glargine; Type 1 diabetes