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Hypoglycemia as a Function of HbA1c in Type 2 Diabetes (T2DM): Insulin Glargine 300 U/mL in a Patient-Level Meta-Analysis of EDITION 1, 2, and 3

Basal insulin therapy can be a compromise between achieving glycemic targets and avoiding hypoglycemia, dependent on how intensively insulin is titrated, noted Riccardo C. Bonadonna, MD, University of Parma, Parma, Italy. Fear of hypoglycemia can lead to sub-optimal insulin dosing, which may impair glycemic control [i].  In the three EDITION trials in patients with type 2 diabetes, insulin glargine 300 U/mL (Gla-300) demonstrated equivalent glycemic control to standard insulin glargine 100 U/mL (Gla-100) with less hypoglycemia, Dr. Bonadonna said at his American Diabetes Association (ADA) 2016 Annual Meeting poster presentation.

In the current meta-analysis, Dr. Bonadonna looked at the rates of confirmed (≤70 mg/dL) or severe hypoglycemia as a function of HbA1c over 6 months of treatment with Gla-300 or Gla-100 in these EDITION clinical trials.  

“The goal, with the better pharmacokinetics and pharmacodynamics of Gla-300 versus Gla-100, is superior control of endogenous glucose production and control of fasting glycemia,” Dr. Bonadonna said in an interview.

In all of the multicenter, randomized, open-label phase 3a EDITION trials, participants (n=2496) received once-daily evening injections of either Gla-300 or Gla-100 titrated to a fasting self-monitored plasma glucose (SMPG) target of 80-100 mg/dL (4.4-5.6 mmol/L).

For this analysis among 2103 subjects with available hypoglycemia and HbA1c data, hypoglycemia was defined as the annualized rate of confirmed (≤70 mg/dL [≤3.9 mmol/L] ) or severe events (ADA definitions) at any time of day and during the night (00:00-5:59 h) and HbA1c (%) at month 6.

Dr. Bonadonna reported that in a patient level review, the between-treatment difference in estimated number of events at any time of day (24 hours) per participant-year when HbA1c is 7.0% at month 6 was roughly 2 fewer in the Gla-300 group, and for nocturnal (00:00-05:59) hypoglycemia was about .8 fewer events. A further analysis looking at the separate EDITION trials, found similar reductions for Gla-300 versus Gla-100, with the exception of hypoglycemia at any time of day in EDITION 1 and nocturnal hypoglycemia in EDITION 3, which had superimposable curves for the two insulins. Likely confounding factors were that EDITION 1 patients were taking mealtime insulin on top of basal insulin and that EDITION 3 patients were insulin naïve prior to the study, leading to fewer hypoglycemia events.

Dr. Bonadonna concluded, “The results consistently showed that the same glucose control could be achieved with Gla-300 as with Gla-100, but with lower hypoglycemia risk. It will offer a great advantage to people with type 2 diabetes being treated with basal insulin.”

[i] Can J Diabetes. 2005;29(3):00-00.

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