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Long-Term Use of Insulin Glargine Maintains Glycemic Control: Presented at ADA
By Jill Stein
Special to DG News
SAN FRANCISCO, CA -- June 17, 2002 -- Insulin glargine maintains its efficacy in glycemic control and its safety profile in the long-term management of patients with type 1 diabetes, with minimal effects on body weight, according to an international study.
Dr. Manfred Dreyer, with Bethanien Hospital in Hamburg, Germany, reported the results here Saturday at the 62nd Scientific Sessions of the American Diabetes Association (ADA).
His study, a 36-week extension of a 28-week multinational, multicenter randomized, open trial, examined the long-term efficacy and safety of insulin glargine when administered in combination with preprandial regular human insulin to patients with type 1 diabetes. Insulin glargine, marketed under the name Lantus by Aventis Pharmaceuticals, is a long-acting human insulin analog developed to have a smooth activity profile with no pronounced peaks and a duration of action suitable for once-daily administration.
In Dr. Dreyer's extension study, 218 eligible patients from the original trial continued taking individually titrated subcutaneous insulin glargine at bedtime in combination with short-acting human insulin before meals. Patients' mean age was 39.5 and mean baseline hemoglobin A1c (HbA1c) level was 8.2 percent.
Results showed that the level of glycemic control achieved in the preceding 28-week study was maintained in this 36-month extension study. A further decrease in HbA1c from baseline to end point of the extension study of 0.41 percent was noted.
Long-term administration of insulin glargine did not reveal any unexpected adverse events compared with the previous study and other short-term studies. The incidence of severe hypoglycemia episodes was low.
Insulin glargine had a minimal effect on body weight, with an average increase of 0.75 kg from baseline to end point.
Insulin glargine was not associated with an adverse immunologic response.
The results show that long-term insulin glargine therapy in patients with type 1 diabetes provides effective glycemic control and is well tolerated when administered once daily at bedtime in a combination regimen with preprandial regular human insulin, said Dr. Dreyer.
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