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Insulin Glargine As Effective As NPH Insulin In Achieving Glycemic Control In Type I Diabetes: Presented at EASD
By Emma Hitt
Special to DG News
BUDAPEST, HUNGARY -- September 2, 2002 -- Insulin glargine appears to be equivalent to, if not more effective than, neutral protamine Hagedorn (NPH) insulin in improving HbA1c and fasting blood glucose (FBG) levels among patients with type I diabetes.
Insulin glargine is a long-acting recombinant human insulin analog indicated for type I and type 2 diabetics. A once-daily injection is thought to minimize hypoglycemia because of its prolonged absorption profile.
Findings of two randomized trials were presented today (September 2) during the European Association for the Study of Diabetes (EASD) meeting, in Budapest, Hungary.
In one study, Dr. Greg Fulcher with the Royal North Shore Hospital, St Leonard's, New South Wales, Australia, and colleagues randomized 49 male and 76 female patients with poorly controlled type I diabetes (HbA1c greater than 8.0 percent) to receive either insulin glargine or NPH insulin at bedtime for 30 weeks.
Patient satisfaction was evaluated using a diabetes treatment satisfaction questionnaire, and severity of hypoglycemic events was classified as mild, moderate, and severe using predetermined criteria.
By the end of the study, HbA1c was reduced significantly in patients receiving insulin glargine compared to those receiving NPH insulin (8.43 percent ± 0.14 percent versus 8.96 percent ± 0.14 percent p=0.01). Similarly, average FBG was 1.19 mM (21.42 mg/dL) lower in the insulin glargine group compared to the NPH insulin group (p<0.05).
Fewer moderate and severe nocturnal hypoglycemic episodes were observed in the insulin glargine group compared to the NPH group, Dr. Fulcher and colleagues report.
At the same session, Dr. Philip Home, with the University of Newcastle upon Tyne, England, and colleagues presented their research, also comparing insulin glargine with NPH insulin in adults with Type 1 diabetes.
A total of 585 patients with type 1 diabetics were randomized to receive once-daily insulin glargine at bedtime, or once- or twice-daily NPH insulin for 28 weeks.
Baseline to endpoint change in FBG and HbA1c were similar between the insulin glargine and NPH insulin treatment groups. However, in patients who had been on a twice-daily basal insulin regimen before the study, "there was a clinically relevant decrease in FBG" in the glargine compared to NPH groups, they report. However, hypoglycemic episodes appeared to be similar in number and severity between the treatment groups.
"The National Institute for Clinical Excellence (NICE) are currently reviewing insulin glargine, and will be issuing guidance on its use over the next 4 months," Dr. Home told Doctor's Guide.
Both studies were funded by Aventis pharmaceuticals.
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