Effect of exenatide on 24-hour blood glucose profile compared with placebo in patients with type 2 diabetes: A randomized, double-blind, two-arm, parallel-group, placebo-controlled, 2-week study

Clinical Therapeutics

Volumn 30, Issue 5, 2008, Pages 858-867

  Schwartz, Sherwyn L ^a   Ratner, Robert E ^b   Kim, Dennis D ^c   Qu, Yongming ^d   Fechner, Linda L ^d   Lenox, Sheila M ^d   Holcombe, John H ^d  

^a Diabetes and Glandular Disease Clinic   (United States)

^b MEDSTAR RESEARCH INSTITUTE   (United States)

^c EnteroMedics Inc   (United States)

^d ELI LILLY AND COMPANY   (United States)

Author keywords

cell secretion; glucose control; glucose regulation; glycemic control; postprandial glucose regulation; triglycerides

Indexed keywords

CARBOHYDRATE; EXENDIN 4; FATTY ACID; GLITAZONE DERIVATIVE; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; PLACEBO; TRIACYLGLYCEROL;

ADULT; ARTICLE; BODY MASS; BODY WEIGHT; CAUCASIAN; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG TREATMENT FAILURE; EVENING DOSAGE; FATTY ACID BLOOD LEVEL; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HISPANIC; HOSPITAL ADMISSION; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; MALE; MEAL; MONOTHERAPY; MORNING DOSAGE; NAUSEA; NEGRO; NON INSULIN DEPENDENT DIABETES MELLITUS; PARALLEL DESIGN; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; TREATMENT DURATION; TREATMENT OUTCOME; TRIACYLGLYCEROL BLOOD LEVEL;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PEPTIDES; POSTPRANDIAL PERIOD; VENOMS;

EID: 44849089357     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2008.05.004     Document Type: Article

References (28)

1. Edwards C., Stanley S., Davis R., et al. Exendin-4 reduces fasting and postprandial glucose and decreases energy intake in healthy volunteers. Am J Physiol Endocrinol Metab 281 (2001) E155-E161
2. Parkes D., Pittner R., Jodka C., et al. Insulinotropic actions of exendin-4 and glucagon-like peptide-1 in vivo and in vitro. Metabolism 50 (2001) 583-589
3. Kolterman O., Buse J., Fineman M., et al. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasma glucose in subjects with type 2 diabetes. J Clin Endocrinol Metab 88 (2003) 3082-3089
4. Holst J., and Gromada J. Role of incretin hormones in the regulation of insulin secretion in diabetic and nondiabetic humans. Am J Physiol Endocrinol Metab 287 (2004) E199-E206
5. Blase E., Taylor K., Gao H., et al. Pharmacokinetics of an oral drug (acetaminophen) administered at various times in relation to subcutaneous injection of exenatide (exendin-4) in healthy subjects. J Clin Pharmacol 45 (2005) 570-577
6. Buse J., Henry R., Han J., et al., for the Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 27 (2004) 2628-2635
7. DeFronzo R., Ratner R., Han J., et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care 28 (2005) 1092-1100
8. Kendall D., Riddle M., Rosenstock J., et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 28 (2005) 1083-1091
9. Monnier L., Lapinski H., and Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: Variations with increasing levels of HbA1c. Diabetes Care 26 (2003) 881-885
10. Chiasson J., Josse R., Gomis R., et al., for the STOP-NIDDM Trial Research Group. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: The STOP-NIDDM trial. JAMA 290 (2003) 486-494
11. Basu A., Alzaid A., Dinneen S., et al. Effects of a change in the pattern of insulin delivery on carbohydrate tolerance in diabetic and nondiabetic humans in the presence of differing degrees of insulin resistance. J Clin Invest 97 (1996) 2351-2361
12. Kolterman O., Gottlieb A., Gaines E., and Fineman M. Five-day dosing of synthetic exendin-4 (AC2993) in people with type 2 diabetes reduces post-prandial glucose, glucagon and triglyceride concentrations. Diabetologia 43 (2000) A189
13. Kolterman O., Kim D., Shen L., et al. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health Syst Pharm 62 (2005) 173-181
14. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 26 (2000) 3080-3086
15. International Conference on Harmonisation-World Health Organization. Guideline for Good Clinical Practice. ICH Topic E6 62 (1997), Published in the Federal Register, FDA 25691E7-25709E7
16. Bennett P. Classification and diagnosis of diabetes mellitus and impaired glucose tolerance. In: Pickup J., and Williams G. (Eds). Textbook of Diabetes Vol 1 (1991), Blackwell Scientific Publications, Oxford, UK 37-44
17. Gluco-quant® Glucose/HK [package insert] (2005), Roche Diagnostics Corporation, Indianapolis, Ind
18. NEFA CACS-ACOD Method [package insert] (2005), Wako Chemicals USA, Inc, Richmond, Va
19. Triglycerides GPO-PAP [package insert] (2003), Roche Diagnostics Corporation, Indianapolis, Ind
20. Gillings D., and Koch G. The application of the principle of intention-to-treat to the analysis of clinical trials. Drug Info J 25 (1991) 411-424
21. Scheffé H. The Analysis of Variance (1959), Wiley, New York, NY
22. Heine R., Van Gaal L., Johns D., et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: A randomized trial. Ann Intern Med 143 (2005) 559-569
23. Nauck M., Duran S., Kim D., et al. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: A noninferiority study. Diabetologia 50 (2007) 259-267
24. Engelgau M., Thompson T., Herman W., et al. Comparison of fasting and 2-hour glucose and HbA1c levels for diagnostic diabetes. Diagnostic criteria and performance revisited. Diabetes Care 20 (1997) 785-791
25. McCance D., Hanson R., Charles M., et al. Comparison of tests for glycated hemoglobin and fasting and two hour plasma glucose concentrations as diagnostic methods for diabetes [published correction appears in BMJ. 1994;309:841]. BMJ 308 (1994) 1323-1328
26. Donahue R., Abbott R., Reed D., and Yano K. Postchallenge glucose concentration and coronary heart disease in men of Japanese ancestry. Honolulu Heart Program. Diabetes 36 (1987) 689-692
27. Heine R., and Dekker J. Beyond postprandial hyperglycaemia: Metabolic factors associated with cardiovascular disease. Diabetologia 45 (2002) 461-475
28. Meier J., Gethmann A., Götze O., et al. Glucagon-like peptide 1 abolishes the postprandial rise in triglyceride concentrations and lowers levels of non-esterified fatty acids in humans. Diabetologia 49 (2006) 452-458