Identification of the mechanism of action of a glucokinase activator from oral glucose tolerance test data in type 2 diabetic patients based on an integrated glucose-insulin model

Journal of Clinical Pharmacology

Volumn 52, Issue 12, 2012, Pages 1861-1871

  Jauslin, Petra M ^a,b   Karlsson, Mats O ^b   Frey, Nicolas ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b UPPSALA UNIVERSITY   (Sweden)

Author keywords

drug disease model; kinetic pharmacodynamic model; Mechanistic model; NONMEM; type 2 diabetes mellitus

Indexed keywords

GLUCOSE; INSULIN;

ADULT; ARTICLE; CLINICAL ARTICLE; DISEASE MODEL; DRUG EFFECT; FEMALE; GLUCONEOGENESIS; GLUCOSE BLOOD LEVEL; HUMAN; INSULIN RELEASE; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; ORAL GLUCOSE TOLERANCE TEST;

ADULT; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GLUCOKINASE; GLUCOSE; GLUCOSE TOLERANCE TEST; HUMANS; INSULIN; MALE; MIDDLE AGED; MODELS, BIOLOGICAL;

EID: 84868616869     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011422231     Document Type: Article

References (27)

1. Jauslin P, Silber HE, Frey N, et al. An integrated glucose-insulin model to describe oral glucose tolerance test data in type 2 diabetics. J Clin Pharmacol. 2007 ; 47: 1244-1255
2. Bergman R, Ider YZ, Bowden CR, Cobelli C. Quantitative estimation of insulin sensitivity. Am J Physiol. 1979 ; 236: E667 - E677
3. Avogaro A, Bristow JD, Bier DM, Cobelli C, Toffolo G. Stable-label intravenous glucose tolerance test minimal model. Diabetes. 1989 ; 38: 1048-1055
4. Caumo A, Cobelli C. Hepatic glucose production during the labeled IVGTT: estimation by deconvolution with a new minimal model. Am J Physiol. 1993 ; 264 (5). E829 - E841
5. De Gaetano A, Arino O. Mathematical modelling of the intravenous glucose tolerance test. J Math Biol. 2000 ; 40: 136-168
6. Mari A. Mathematical modeling in glucose metabolism and insulin secretion. Curr Opin Clin Nutr Metab Care. 2002 ; 5: 495-501
7. Sorensen JT, Colton CK, Hillman RS, Soeldner JS. Use of a physiologic pharmacokinetic model of glucose homeostasis for assessment of performance requirements for improved insulin therapies. Diabetes Care. 1982 ; 5: 148-157
8. Vicini P, Caumo A, Cobelli C. The hot IVGTT two-compartment minimal model: indexes of glucose effectiveness and insulin sensitivity. Am J Physiol. 1997 ; 273 (5). E1024 - E1032
9. Silber HE, Jauslin PM, Frey N, Gieschke R, Simonsson US, Karlsson MO. An integrated model for glucose and insulin regulation in healthy volunteers and type 2 diabetic patients following intravenous glucose provocations. J Clin Pharmacol. 2007 ; 47: 1159-1171
10. Agersø H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003 ; 19: 141-150
11. Marshall S, Macintyre F, James I, Krams M, Jonsson NE. Role of mechanistically-based pharmacokinetic/pharmacodynamic models in drug development: a case study of a therapeutic protein. Clin Pharmacokinet. 2006 ; 45: 177-197
12. Matschinsky FM, Magnuson MA, Zelent D, et al. The network of glucokinase-expressing cells in glucose homeostasis and the potential of glucokinase activators for diabetes therapy. Diabetes. 2006 ; 55: 1-12
13. Matschinsky FM. Glucokinase as glucose sensor and metabolic signal generator in pancreatic beta-cells and hepatocytes. Diabetes. 1990 ; 39: 647-652
14. Printz RL, Granner DK. Tweaking the glucose sensor: adjusting glucokinase activity with activator compounds. Endocrinology. 2005 ; 146: 3693-3695
15. El Kenz H, Bergmann P. Evaluation of immunochemiluminometric assays for the measurement of insulin and C-peptide using the ADVIA Centaur. Clin Lab. 2004 ; 50: 171-174
16. Jacqmin P, Snoeck E, van Schaick EA, et al. Modelling response time profiles in the absence of drug concentrations: definition and performance evaluation of the K-PD model. J Pharmacokinet Pharmacodyn. 2007 ; 34: 57-85
17. Beal S, Sheiner LB NONMEM Users Guide (I-VIII). Hanover, MD: GloboMax LLC ; 1989-1998 :
18. Lindbom L, Pihlgren P, Jonsson EN. PsN-Toolkit: a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005 ; 79: 241-257
19. Fabietti PG, Canonico V, Orsini-Federici M, Sarti E, Massi-Benedetti M. Clinical validation of a new control-oriented model of insulin and glucose dynamics in subjects with type 1 diabetes. Diabetes Technol Ther. 2007 ; 9: 327-338
20. Steil GM, Clark B, Kanderian S, Rebrin K. Modeling insulin action for development of a closed-loop artificial pancreas. Diabetes Technol Ther. 2005 ; 7: 94-108
21. Verotta D, Sheiner LB. Semiparametric analysis of non-steady-state pharmacodynamic data. J Pharmacokinet Biopharm. 1991 ; 19: 691-712
22. Gabrielsson J, Jusko WJ, Alari L. Modeling of dose-response-time data: four examples of estimating the turnover parameters and generating kinetic functions from response profiles. Biopharm Drug Dispos. 2000 ; 21: 41-52
23. Gruwez B, Poirier MF, Dauphin A, Olie JP, Tod M. A kinetic- pharmacodynamic model for clinical trial simulation of antidepressant action: application to clomipramine-lithium interaction. Contemp Clin Trials. 2007 ; 28: 276-287
24. Pillai G, Gieschke R, Goggin T, Jacqmin P, Schimmer RC, Steimer JL. A semimechanistic and mechanistic population PK-PD model for biomarker response to ibandronate, a new bisphosphonate for the treatment of osteoporosis. Br J Clin Pharmacol. 2004 ; 58: 618-631
25. Postic C, Shiota M, Niswender KD, et al. Dual roles for glucokinase in glucose homeostasis as determined by liver and pancreatic beta cell-specific gene knock-outs using Cre recombinase. J Biol Chem. 1999 ; 274: 305-315
26. Postic C, Shiota M, Magnuson MA. Cell-specific roles of glucokinase in glucose homeostasis. Recent Prog Horm Res. 2001 ; 56: 195-217
27. Jauslin PM, Frey N, Karlsson MO. Modeling of 24-hour glucose and insulin profiles of patients with type 2 diabetes. J Clin Pharmacol. 2010 ; 51: 153-164