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A new insulin glargine is 300 U / mL compared to
a glargine of 100 U / mL in Japanese adults with type 1 diabetes using basal and insulin intake: glucose control and hypoglycemia in a randomized controlled study (EDITION JP 1).
Matsuhisa M 1, Koyama M 2, Cheng X 3, Takahashi Y 2, Riddle MC 4, Bolli GB 5, Hirose T 6; EDITION JP 1 research group.
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Abstract
AIM:
To compare the efficacy and safety of the new glargine 300 U / ml (Gla- 300) with insulin glargine 100 U / ml (Gla-100) in adults of Japanese with type 1 diabetes.
METHODS:
The EDITION study JP 1 (NCT01689129) was a six-month, multicenter, open-label phase III study. Participants (n = 243) were randomized to Gla-300 or Gla-100, continuing insulin for food intake. Basal insulin was titrated to achieve the self-controlled plasma glucose plasma delivered by 4.4-7.2 mmol / l. The primary endpoint was a change in glycated hemoglobin (HbA1c) for 6 months. Safety measures included hypoglycemia and weight change.
RESULTS:
Gla-300 did not exceed Gla-100 for the primary end point of HbA1c change during the 6-month period {smallest mean-square [LS] 0.13% [95% confidence interval (CI) -0.03-0.29]} . The annual rate of confirmed (≤3.9 mmol / L) or severe hypoglycemic events was 34% lower with Gla-300 than with Gla-100 at night (coefficient 0.66 (95% CI 0.48-0.92 )] and 20% lower at any time of day [24 h, a ratio of 0.80 (95% CI 0.65-0.98)], the difference was most pronounced during the first 8 weeks of treatment. [1] Severe hypoglycemia was infrequent The basal insulin dose increased in both groups (dose of the 6th month: Gla-3000.35 U / kg / day, Gla-100 0.29 U / kg / day) There was a difference between treatment in changing body weight in for 6 months in favor of Gla-30 0 [mean difference LS -0.6 kg (95% CI -1.1 to -0.0), p = 0.035.] Adverse events were comparable between groups.
CONCLUSIONS:
In adults of Japanese with type 1 diabetes using insulin with basal supplementation, as well as with hypoglycaemia, less hypoglycaemia with Gla-300 was observed than with Gla-100, especially overnight, while glycemic control was not different.
© 2015 Authors. Diabetes, obesity and metabolism, published by John Wiley & Sons Ltd