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Severe Symptomatic Hypoglycaemia Less Frequent with Insulin Glargine than NPH Insulin in Type 2 Diabetics: Presented at IDF

By Jill Stein

PARIS, FRANCE -- August 25, 2003 -- New data indicate that insulin glargine (Lantus) as a basal insulin facilitates at least equivalent glycaemic control to NPH insulin, with lower fasting plasma glucose and significantly less severe hypoglycaemia, in type 2 diabetics.

The results were reported on today at the Eighteenth International Diabetes Federation (IDF) Congress.

Dr. George Dailey, with Scripps Clinic in La Jolla, California, United States, and colleagues elsewhere conducted a meta-analysis of all phase III/IIIb studies performed to date with insulin glargine versus NPH insulin. These studies were 16 to 28 weeks in duration, except for one study of 52 weeks' duration, where interim 20-week data were used. In the trials, insulin glargine was administered once daily and NPH insulin once or twice daily. A total of 2,304 patients were enrolled in the studies.

Baseline characteristics and demographics were comparable in the two treatment groups.

Results showed that the mean endpoint haemoglobin A1 C was similar with insulin glargine (7.8 ±1.3%) and NPH insulin (7.7 ±1.2%).

The overall incidence of severe hypoglycaemia was significantly lower with insulin glargine versus NPH insulin (p=0.0442). The difference between the two groups was largely due to significant reductions in the incidence of nocturnal episodes (p=0.0231).

There was no significant between-treatment difference in the rate of non-nocturnal severe hypoglycaemia (p=0.7296).

Overall, 1.4% of insulin glargine-treated patients experienced 24 episodes of severe hypoglycaemia, while 2.8% of NPH insulin patients experienced 42 episodes of severe hypoglycaemia, p = 0.0237. This translates into a 50% risk reduction in the incidence of severe hypoglycaemia with insulin glargine versus NPH insulin use.

Dr. Dailey said that the results show that insulin glargine is especially worthwhile for "treat-to-target" regimens that involve titration of basal insulin to strict blood glucose targets.

"With the growing trend towards tighter glycaemic control in type 2 diabetics, insulin glargine represents a valuable addition to the treatment options for these patients, and may allow more of them to reach glycaemic control targets without compromising safety," he added.

The study was supported by Aventis Pharma in Bridgewater, New Jersey.


[Study title: A meta-analysis of phase III/IIIb studies comparing insulin glargine with human NPH in Type 2 dibetes: severe hypoglcaemia is less common with insulin gargine. Abstract 880]

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