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| |  ESPE: Study Compares Insulin Glargine With NPH Insulin In Children With Type 1 Diabetes By Cameron Johnston Special to DG News
MONTREAL, QC -- July 10, 2001 -- A single bedtime dose of insulin glargine (Lantus, Aventis Pharma) appears to be as effective as NPH insulin for children with Type 1 diabetes. A new study presented here (July 8) by Dr. Birgit Rami, of the University Children’s Hospital, in Vienna, Austria, marks the first time glargine is studied in such a large group of children (n=349). The presentation was made in a poster session at the at the 6th joint meeting of the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology (ESPE) in collaboration with the Australasian Paediatric Endocrine Group, the Japanese Society for Pediatric Endocrinology, and the Latin American Society for Paediatric Endocrinology. The data indicate that insulin Glargine is "no different, and no worse" than NPH insulin, she said. The study was conducted at 30 centres in nine European countries and in South Africa, and was organized by the Pediatric Study Group for Insulin Glargine, based in Vienna, Austria. In the study, children aged six to 15 years were given either a once daily bedtime dose of insulin glargine, or one or two daily doses of NPH insulin over a six-month period. They were also backed up with normal mealtime insulin. Insulin glargine was developed to address the issue of short-life ultralente and NPH insulin, which results in them losing efficacy quickly and in rapidly fluctuating serum levels. Insulin Glargine is reported to be a recombinant insulin analogue with a smooth 24-hour profile. The only statistically significant difference between glargine and NPH insulin was the 16-week decrease in fasting blood glucose levels from baseline, which was -1.49 in the glargine group and -0.52 in the NPH group (p=0.001). The fasting blood glucose level at end point was less significant (-1.29 versus -0.68; p=0.023). There was also a decrease in basal doses of insulin glargine, from 19.5 units to 18.2 units (baseline to end point, respectively), whereas the basal dose of NPH insulin increased from 18.7 units to 21.1 units. Neither of these changes was statistically significant. Total daily insulin doses increased slightly in both groups. No differences were observed in glycosylated hemoglobin levels. Overall, the incidence of hypoglycemia was 79.3 versus 78.9 percent, and the incidence of severe hypoglycemia was 23.0 versus 28.6 percent (Glargine versus NPH insulin, respectively). The incidence of nocturnal hypoglycemia overall was 48.3 versus 50.9 percent, whereas severe nocturnal hypoglycemia was 12.6 percent versus 17.7 percent (Glargine versus NPH insulin, respectively). Overall, the incidence of adverse events, mostly related to metabolic control, was significantly lower in the NPH group as compared with the glargine group (13.7 percent versus 5.7 percent p=0.02). Injection site reactions were the same for both drugs, and laboratory values did not reveal any significant issues with respect to pulse, blood pressure, body weight and overall tolerability. "We were not able to get blood glucose normalized," she added. It might be clinically important that the patients in the insulin glargine group experienced fewer severe hypoglycemic episodes, and particularly severe nocturnal hypoglycemic episodes, even though these data did not reach statistical significance, she said.
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