Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2015 Sep;17(9):859-67.
doi: 10.1111/dom.12485. Epub 2015 Jun 16.

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

R Ritzel  1 , R Roussel  2   3   4 , G B Bolli  5 , L Vinet  6 , C Brulle-Wohlhueter  7 , S Glezer  7 , H Yki-Järvinen  8
Affiliations
Meta-Analysis

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

R Ritzel et al. Diabetes Obes Metab. 2015 Sep.

Abstract

Aims: To conduct a patient-level meta-analysis of the EDITION 1, 2 and 3 studies, which compared the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) in people with type 2 diabetes (T2DM) on basal and mealtime insulin, basal insulin and oral antihyperglycaemic drugs, or no prior insulin, respectively.

Methods: The EDITION studies were multicentre, randomized, open-label, parallel-group, phase IIIa studies, with similar designs and endpoints. A patient-level meta-analysis of the studies enabled these endpoints to be examined over 6 months in a large population with T2DM (Gla-300, n = 1247; Gla-100, n = 1249).

Results: No significant study-by-treatment interactions across studies were found, enabling them to be pooled. The mean change in glycated haemoglobin was comparable for Gla-300 and Gla-100 [each -1.02 (standard error 0.03)%; least squares (LS) mean difference 0.00 (95% confidence interval (CI) -0.08 to 0.07)%]. Annualized rates of confirmed (≤3.9 mmol/l) or severe hypoglycaemia were lower with Gla-300 than with Gla-100 during the night (31% difference in rate ratio over 6 months) and at any time (24 h, 14% difference). Consistent reductions were observed in percentage of participants with ≥1 hypoglycaemic event. Severe hypoglycaemia at any time (24 h) was rare (Gla-300: 2.3%; Gla-100: 2.6%). Weight gain was low (<1 kg) in both groups, with less gain with Gla-300 [LS mean difference -0.28 kg (95% CI -0.55 to -0.01); p = 0.039]. Both treatments were well tolerated, with similar rates of adverse events.

Conclusion: Gla-300 provides comparable glycaemic control to Gla-100 in a large population with a broad clinical spectrum of T2DM, with consistently less hypoglycaemia at any time of day and less nocturnal hypoglycaemia.

Keywords: basal insulin; insulin glargine; insulin therapy.

PubMed Disclaimer

Figures

Figure 1
Figure 1
(A) Glycated haemoglobin (HbA1c), (B) Laboratory-measured fasting plasma glucose (FPG), (C) Insulin dose [modified intention-to-treat (mITT) population and (D) body weight (safety population) by visit during the 6-month treatment period for pooled analysis of all three studies. Gla-100, insulin glargine 100 U/ml; Gla-300, insulin glargine 300 U/ml; LS, least squares; BL, baseline; M, month; s.e, standard error; W, week. LOV, last on-treatment value defined as the last measurement made prior to or on the day of the last investigational product intake during the main 6-month on-treatment period.
Figure 2
Figure 2
Cumulative mean number of confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemic events (A) at any time of day (24 h) and (B) during the night (00:00–05:59 hours) for pooled analysis of all three studies (safety population). Gla-100, insulin glargine 100 U/ml; Gla-300, insulin glargine 300 U/ml.
Figure 3
Figure 3
Annualized rates and percentage of participants with ≥1 hypoglycaemic event (A) at any time of day (24 h) and (B) during the night (00:00–05:59 hours) for pooled analysis of all three studies (safety population). Gla-100, insulin glargine 100 U/ml; Gla-300, insulin glargine 300 U/ml; CI, confidence interval; BL, baseline; W, week; M, month.
Figure 4
Figure 4
Annualized rates (events per participant-year) of confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia during 6 months of treatment by time of the day for pooled analysis of all three studies (safety population). Gla-100, insulin glargine 100 U/ml; Gla-300, insulin glargine 300 U/ml.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Polonsky KS. The past 200 years in diabetes. N Engl J Med. 2012;367:1332–1340. - PubMed
    1. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetes Care. 2012;35:1364–1379. - PMC - PubMed
    1. Holman RR, Farmer AJ, Davies MJ, et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361:1736–1747. - PubMed
    1. Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD. 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;37:2755–2762. - PubMed
    1. 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;37:3235–3243. - PubMed

Publication types

  NODES
admin 2
Association 2
chat 2
twitter 2