| Evaluation of the reproductive toxicity and embryotoxicity of insulin glargine (LANTUS) in rats and rabbits. | |
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MedLine Citation:
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PMID: 12055019 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Insulin glargine (LANTUS) is a new insulin analog that has a prolonged duration of action with no pronounced peak of activity, rendering it an ideal basal insulin for the treatment of diabetes. The aim of these studies was to assess the reproductive and embryotoxicity of insulin glargine. Reproductive toxicity was assessed in 25 male and 25 female Wistar rats per group treated with a daily subcutaneous injection of control; 1 IU/kg, 3 IU/kg, and 10 IU/kg insulin glargine; or 3 IU/kg NPH insulin in the premating and mating periods, and throughout pregnancy and lactation in the females. Embryotoxicity was assessed in 20 female rats per group injected with daily subcutaneous doses of control; 2 IU/kg, 6.3 IU/kg, and 20 IU/kg insulin glargine; or 6.3 IU/kg NPH insulin from the 7th to 18th day of pregnancy. Embryotoxicity was also assessed in 20 female rabbits per group treated with 0 IU/kg, 0.5 IU/kg, 1 IU/kg, and 2 IU/kg insulin glargine, or 1 IU/kg NPH insulin from the 6th to 18th day of pregnancy. The data demonstrated that, with the exception of toxicologic effects induced by hypoglycemia in response to high doses of insulin glargine and NPH insulin (including the premature dropout of female rats in the reproductive toxicity study, and increased incidence of abortions, early intrauterine deaths, and single anomalies in the rabbit embryotoxicity study), insulin glargine had no effects on reproduction, embryofetal development, and postnatal development in rats. Maternal and embryofetal toxicity in rabbits treated with middle and high doses of insulin glargine was related to the hypoglycemic effect of insulin. |
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Authors:
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Thomas Hofmann; Georg Horstmann; Ingo Stammberger |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: International journal of toxicology Volume: 21 ISSN: 1091-5818 ISO Abbreviation: Int. J. Toxicol. Publication Date: 2002 May-Jun |
Date Detail:
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Created Date: 2002-06-10 Completed Date: 2002-12-30 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9708436 Medline TA: Int J Toxicol Country: United States |
Other Details:
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Languages: eng Pagination: 181-9 Citation Subset: IM |
Affiliation:
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Aventis Pharma Germany, Hattersheim, Germany. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Animals Dose-Response Relationship, Drug Drug Evaluation, Preclinical Embryonic and Fetal Development / drug effects* Female Hypoglycemia / chemically induced Hypoglycemic Agents / toxicity* Injections, Subcutaneous Insulin / analogs & derivatives*, toxicity* Male Pregnancy Rabbits Rats Rats, Wistar Reproduction / drug effects Toxicity Tests, Chronic |
| Chemical | |
Reg. No./Substance:
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0/Hypoglycemic Agents; 0/glargine; 11061-68-0/Insulin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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