Effects of the oral antidiabetic repaglinide on the reproduction of rats

Arzneimittel-Forschung/Drug Research

Volumn 50, Issue 5, 2000, Pages 425-440

  Viertel, Bruno ^a   Güttner, Jürgen ^a  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Biguanide; CAS 135062 02 1; Long bone deformities; Non teratogenic growth effect; Pancreatic cell stimulating oral antidiabetic; Repaglinide, reproduction studies

Indexed keywords

ORAL ANTIDIABETIC AGENT; REPAGLINIDE;

ANIMAL EXPERIMENT; ARTICLE; DRUG EFFECT; DRUG SAFETY; EMBRYO DEVELOPMENT; EMBRYOTOXICITY; FEMALE; FERTILITY; FETUS DEVELOPMENT; INSULIN RELEASE; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; RAT; TERATOGENESIS;

EID: 0034072289     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1300227     Document Type: Article

References (33)

1. [1] Mark, M., Grell, C., Hypoglycaemic effects of the novel antidiabetic agent repaglinide in rats and dogs. Brit. J. Pharmacol. 121, 1597 (1997)
2. [2] Tanigawa, K., Kawaguchi, M., Tanaka, O. et al., Long-term effect of maternal insulin-induced hypoglycemia during organogenesis. Diabetes 40, 1115 (1991).
3. [3] Buchanan, T. A., Schemmer, J. K., Freinkel, N., Embryotoxic effects of brief maternal insulin-hypoglycemia during organogenesis in the rat. J. Clin. Invest. 78, 643 (1986).
4. [4] Heisig, N., Schröder, G., Der Einfluß von parenteralen durch Glibenclamid (HB 419) induzierten Hypoglykämien in der Gravidität der Ratte auf die perinatale Mortalität der Nachkommen. Arzneim.-Forsch./Drug Res. 21 (I), 846 (1971)
5. [5] Hartig, F., Langer, K. H., Rebel, W et al., Toxicology of sulfonylureas. In: G. V. R Born, P. Cuatrecasas, D. Ganten et al., Handbook of experimental pharmacology. Springer Verlag, Berlin (1996)
6. [6] Kawanishi, H., Takeshima, T., Igarashi, N. et al., Reproduction studies of Gliclazide, a new sulfonylurea antidiabetic agent. Pharmacometrics 9, 65 (1981)
7. [7] Tettenborn, D., Zur Toxikologie von Glisoxepid, einem neuen oralen Antidiabetikum. Ergebnisse der Tierversuche. (The toxicology of glisoxepide, a new oral antidiabetic. Results in animal studies.). Arneim./Drug Res. 24 (I), 409 (1974)
8. [8] Schärer, K., Hummler, H., Toxicological experiments with drugs of the sulfonylurea type in animals. In: U. Ch. Dubach, Recent Hypoglycemic Sulfonylureas, International Symposium (1970). Hans Huber Publishers, Bern (1971)
9. [9] Ida, H., Kast, A., Tsunenari, Y., Studies on the teratogenicity of a new sulfonylurea derivative (ARDF 26 SE) on rats and rabbits. Pharmacometrics 11, 119 (1976)
10. [10] Kreutz, R., Die Wirkung der mehrmaligen Gabe von Carbutamid auf die Keimlingsentwicklung der Ratte. (The effect of repeated application of carbutamide on the embryonic development of the rat.). Anat. Anz. 146, 427 (1979)
11. [11] Akazawa, S, Akazawa, M., Hashimoto, M. et al., Effects of hypoglycaemia on early embryogenesis in rat embryo organ culture. Diabetologia 30, 791 (1987).
12. [12] Ellington, S. K. L., Development of rat embryos cultured in glucose-deficient media. Diabetes 36, 1372 (1987a)
13. [13] Ellington, S.K.L., In vitro analysis of glucose metabolism and embryonic growth in postimplantation rat embryos. Development 100, 431 (1987b)
14. [14] Ellington, S.K.L., In-vivo and in-vitro studies on the effects of maternal fasting during embryonic organo-genesis in the rat. J. Reprod. Fertil. 60, 383 (1980)
15. [15] EEC Drug Registration: Note for Guidance. Council recommendation concerning tests related to the placing on the market of proprietary medicinal products (83/571/EEC, 1983)
16. [16] EEC-Directive. Guidelines on the quality, safety and efficacy of medicinal products for human use (75/318 Vol. III, 1989)
17. [17] International Conference on Harmonization (ICH), Tripartite Guideline: Guideline on Detection of Toxicity to Reproduction for Medicinal Products, US Fed. Reg. Vol. 58, No. 72, April 15, 1993
18. [18] Bekanntmachung der OECD-Grundsätze der Guten Laborpraxis vom 3. Februar 1983, Bundesanzeiger, 2. März 1983, Jg. 35, Nr. 42a
19. [19] German Animal Protection Law (Bekanntmachung der Neufassung des Tierschutzgesetzes), Bundesgesetzblatt Teil 1, No. 42, 1319 (1986)
20. [20] Baumeister, M., AG-EE 623 ZW: Study on fertility and general reproductive performance in rats after oral treatment (gavage) Segment I. Report, Dr. Karl Thomae GmbH, Biberach, February 26, 1993
21. [21] Viertel, B., Stangier, J., AG-EE 623 ZW: Study for effects on embryofetal development in rats by oral administration (gavage), littering group included. Report, Dr. Karl Thomae GmbH, Biberach, February 7, 1997
22. [22] Viertel, B., Stangier, J., AG-EE 623 ZW: Study of peri-and postnatal development in rats after oral treatment by gavage (Segment III). Report, Dr. Karl Thomae GmbH, Biberach, October 21, 1993
23. [23] Salewski, E., Färbemethode zum makroskopischen Nachweis von Implantationsstellen am Uterus der Ratte. Exp. Pathol. Pharmakol. 247, 367 (1964)
24. [24] Barrow, M. V., Taylor, W. J., A rapid method for detecting malformations in rat fetuses. J. Morphol. 127, 29 (1969)
25. [25] Wilson, J. G., Methods for administering agents and detecting malformations in experimental animals. In: J. G. Wilson, Warkany, J. Teratology Principles and Techniques. The University of Chicago Press, Chicago-London (1965)
26. [26] Viertel, B., Güttner, J., AG-EE 623 ZW: Supplementary study of peri-and postnatal development in rats after oral treatment by gavage at five different treatment windows (Segment III). Report, Dr. Karl Thomae GmbH, Biberach, August 25, 1994
27. [27] Sokal, R. R., Rohlf, F. J., Biometry: The principles and practice of statistics in biological research. W. H. Freeman Co., San Francisco (1969)
28. [28] Khera, K. S., Maternal toxicity - a possible factor in fetal malformations in mice. Teratology 29, 411 (1984)
29. [29] Khera, K. S., Maternal toxicity: a possible etiological factor in embryo-fetal deaths and fetal malformations of rodent-rabbit species. Teratology 31, 129 (1985)
30. [30] Strong, R. M., The order, time, and rate of ossification of the albino rat (Mus norvegicus albinus) skeleton. Am. J. Anat. 36, 313 (1925)
31. [31] Donaldson, H. H., Conrow. S., Quantitative studies on the growth of the skeleton of the albino rat. Am. J. Anat. 26, 237 (1919)
32. [32] Burckhardt, H., Knochenregeneration. Brun's Beitr. klin. Chirurgie 137, 63 (1926)
33. [33] Rodriguez, J. I., Garcia-Alix, A., Palacios, J. et al., Changes in long bones due to fetal immobility caused by neuromuscular disease. J. Bone Joint Surgery 70-A, 1052 (1988)