The effect of nateglinide taken with food on gastric emptying rates in healthy subjects

Clinical Therapeutics

Volumn 25, Issue 6, 2003, Pages 1722-1738

  Anderson, Denise ^a,b   Shelley, Sarah ^c   Kellett, Norma ^d   Marshall, Dianne ^d   Nimmo, Walter ^d  

^a Ajinomoto Pharmaceut Europe Limited   (United Kingdom)

^b Andromeda Consultancy   (United Kingdom)

^c GCP Management Services Limited   (United Kingdom)

^d Inveresk Research   (United Kingdom)

Author keywords

Food effect; Gastric emptying; Nateglinide; Pharmacokinetics

Indexed keywords

NATEGLINIDE; PARACETAMOL; PLACEBO;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISEASE ASSOCIATION; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG TOLERABILITY; FOOD DRUG INTERACTION; FOOD INTAKE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HUMAN EXPERIMENT; INSULIN BLOOD LEVEL; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINORRHEA; SIDE EFFECT; STATISTICAL SIGNIFICANCE; STOMACH EMPTYING; UPPER RESPIRATORY TRACT INFECTION; VIRUS INFECTION;

EID: 0038354971     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(03)80165-0     Document Type: Article

References (36)

1. Taylor SI, Accili D, Imai Y. Insulin resistance or insulin deficiency. Which is the primary cause of NIDDM? Diabetes. 1994;43:735-740.
2. Groop LC, Widen E., Ferrannini E. Insulin resistance and insulin deficiency in the pathogenesis of type 2 (non-insulin-dependent) diabetes mellitus: Errors of metabolism or of methods? Diabetologia. 1993;36:1326-1331.
3. Ward WK, Bolgiano DC, McKnight B, et al. Diminished β cell secretory capacity in patients with noninsulin-dependent diabetes mellitus. J Clin Invest. 1984;74:1318-1328.
4. DeFronzo RA, Bonadonna RC, Ferrannini E. Pathogenesis of NIDDM. A balanced overview. Diabetes Care. 1992;15:318-368.
5. Kelley D, Mokan M, Veneman T. Impaired postprandial glucose utilization in non-insulin-dependent diabetes mellitus. Metabolism. 1994;43:1549-1557.
6. Firth RG, Bell PM, Marsh HM, et al. Postprandial hyperglycemia in patients with non-insulin-dependent diabetes mellitus. Role of hepatic and extrahepatic tissues. J Clin Invest. 1986;77:1525-1532.
7. Asplund K, Wiholm BE, Lithner F. Glibenclamide-associated hypoglycaemia: A report on 57 cases. Diabetologia. 1983;24:412-417.
8. Ferner RE, Neil HA. Sulphonylureas and hypoglycaemia. Br Med J (Clin Res Ed). 1988;296:949-950.
9. Barrett-Connor E, Ferrara A, for the Rancho Bernardo Study. Isolated postchallenge hyperglycemia and the risk of fatal cardiovascular disease in older women and men. Diabetes Care. 1998;21:1236-1239.
10. Glucose tolerance and mortality: Comparison of WHO and American Diabetes Association diagnostic criteria. The DECODE Study Group. European Diabetes Epidemiology Group. Diabetes Epidemiology: Collaborative analysis Of Diagnostic criteria in Europe. Lancet. 1999;354:617-621.
11. Hanefeld M, Fischer S, Julius U, et al. Risk factors for myocardial infarction and death in newly detected NIDDM: The Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996;39:1577-1583.
12. Avignon A, Radauceanu A, Monnier L. Nonfasting plasma glucose is a better marker of diabetic control than fasting plasma glucose in type 2 diabetes. Diabetes Care. 1997;20:1822-1826.
13. DeFronzo RA, Ferrannini E. Insulin resistance. A multifaceted syndrome responsible for NIDDM, obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Diabetes Care. 1991;14:173-194.
14. Zimmerman BR, Espenshade J, Fujimoto WY, et al. The pharmacological treatment of hyperglycemia in NIDDM. Diabetes Care. 1996;19(Suppl 1):S54-S61.
15. Kahn SE, Montgomery B, Howell W, et al. Importance of early phase insulin secretion to intravenous glucose tolerance in subjects with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2001;86:5824-5829.
16. Hollander PA, Schwartz SL, Gatlin MR, et al. Importance of early insulin secretion: Comparison of nateglinide and glyburide in previously diet-treated patients with type 2 diabetes. Diabetes Care. 2001;24:983-988.
17. Ikenoue T, Akiyoshi M, Fujitani S, et al. Hypoglycaemic and insulinotropic effects of a novel oral antidiabetic agent, (-)-N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine (A-4166). Br J Pharmacol. 1997;120:137-145.
18. Sato Y, Nishikawa M, Shinkai H, Sukegawa E. Possibility of ideal blood glucose control by a new oral hypoglycemic agent, N-[(trans-4-isopropylcyclohexyl)-carbonyl]-D-phenylalanine (A-4166), and its stimulatory effect on insulin secretion in animals. Diabetes Res Clin Pract. 1991;12:58-59.
19. Hanefeld M, Bouter KP, Dickinson S, Guitard C. Rapid and short-acting mealtime insulin secretion with nateglinide controls both prandial and mean glycemia. Diabetes Care. 2000;23:202-207.
20. Karara AH, Dunning BE, McLeod JF. The effect of food on the oral bioavailability and the pharmacodynamic actions of the insulinotropic agent nateglinide in healthy subjects. J Clin Pharmacol. 1999;39:172-179.
21. Clements JA, Heading RC, Nimmo WS, Prescott LF. Kinetics of acetaminophen absorption and gastric emptying in man. Clin Pharmacol Ther. 1978;24:420-431.
22. Willems M, Quartero AO, Numans ME. How useful is paracetamol absorption as a marker of gastric emptying? A systematic literature study. Dig Dis Sci. 2001;46:2256-2262.
23. Sanaka M, Kuyama Y, Yamanaka M. Guide for judicious use of the paracetamol absorption technique in a study of gastric emptying rate of liquids. J Gastroenterol. 1998;33:785-791.
24. Hampton SM, Withey L. Monitoring beta cell responses in obese and normal weight subjects - a pilot study. Diabet Metab. 1993;19:582-585.
25. Granneman GR, Mukherjee D. The effect of food on the bioavailability of temafloxacin: A review of 3 studies. Clin Pharmacokinet. 1992;22(Suppl 1):48-56.
26. Welling PG, Tse FL. Food interactions affecting the absorption of analgesic and anti-inflammatory agents. Drug Nutr Interact. 1983;2:153-168.
27. Melander A, McLean A. Influence of food intake on presystemic clearance of drugs. Clin Pharmacokinet. 1983;8:286-296.
28. Anderson KE. Influences of diet and nutrition on clinical pharmacokinetics. Clin Pharmacokinet. 1998;14:325-346.
29. Welling PG. Effects of food on drug absorption. Ann Rev Nutr. 1996;16:383-415.
30. Singh BN. Effects of food on clinical pharmacokinetics. Clin Pharmacokinet. 1999;37:213-255.
31. Horowitz M, O'Donovan D, Jones KL, et al. Gastric emptying in diabetes: Clinical significance and treatment. Diabet Med. 2002;19:177-194.
32. DeFronzo RA, Ferrannini E, Koivisto V. New concepts in the pathogenesis and treatment of noninsulin-dependent diabetes mellitus. Am J Med. 1983;74:52-81.
33. Kahn SE, McCulloch DK, Porte D. Insulin secretion in the normal and diabetic human. In: Alberti KG, Zimmet P, DeFonzo RA, Keen H, eds. International Textbook of Diabetes Mellitus. Vol 1. 2nd ed. New York: Wiley; 1997:337-353.
34. Bruttomesso D, Pianta A, Mari A, et al. Restoration of early rise in plasma insulin levels improves the glucose tolerance of type 2 diabetic patients. Diabetes. 1999;48:99-105.
35. Mitrakou A, Kelley D, Mokan M, et al. Role of reduced suppression of glucose production and diminished early insulin release in impaired glucose tolerance. N Engl J Med. 1992;326:22-29.
36. Kikuchi M. Modulation of insulin secretion in non-insulin-dependent diabetes mellitus by two novel oral hypoglycaemic agents, NN623 and A4166. Diabet Med. 1996;13(Suppl 6):S151-S155.