The clinical efficacy and safety of Glucagon-like peptide-1 (GLP-1) agonists in adults with type 2 diabetes mellitus

Clinical Medicine Insights: Endocrinology and Diabetes

Volumn 4, Issue , 2011, Pages 13-24

  Brice, Kira R ^a   Tzefos, Maria K ^a  

^a WINGATE UNIVERSITY   (United States)

Author keywords

Exenatide; Glucagon like peptide 1; Liraglutide; Type 2 diabetes mellitus

Indexed keywords

EXENDIN 4; GLIMEPIRIDE; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1; INSULIN GLARGINE; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA;

ABDOMINAL PAIN; ADD ON THERAPY; ADULT; AREA UNDER THE CURVE; BEDTIME DOSAGE; CELL FUNCTION; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG MECHANISM; DRUG PREFERENCE; DRUG SAFETY; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPOGLYCEMIA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MORNING DOSAGE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PANCREATITIS; REVIEW; SIDE EFFECT; VOMITING; WEIGHT REDUCTION;

EID: 79952722671     PISSN: 11795514     EISSN: 11795514     Source Type: Journal    
DOI: 10.4137/CMED.S4086     Document Type: Review

References (47)

1. Turner RC, Holman RR, Cull CA, Stratton IM, Matthews DR, Frighi V, et al. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853.
2. Hoerger TJ, Gregg EW, Segel JE, Saaddine JB. Is glycemic control improving in US adults? Diabetes Care. 2008;31:81-86.
3. Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007;87: 1409-439.
4. Frias JP, Edelman SV. Incretins and their role in the management of diabetes. Curr Opin Endocrinol Diabetes Obes. 2007;14:269-276.
5. Nauck MA, Baller B, Meier JJ. Gastric inhibitory polypeptide and glucagon-like peptide-1 in the pathogenesis of type 2 diabetes. Diabetes. 2004;53:S190-196.
6. Kreymann B, Ghatei MA, Williams G, Bloom SR. Glucagon-like peptide-1 7-36: A physiological incretin in man. Lancet. 1987;2:1300-1304.
7. Nauck M, Stockmann F, Ebert R, Creutzfeldt W. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia. 1986;29:46-52.
8. Nauck MA, Kleine N, Orskov C, Holst JJ, Willms B, Creutzfeldt W. Normalization of fasting hyperglycemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1993;36:741-744.
9. Tof-Nielsen M, Madsbad S, Holst JJ. Continuous subcutaneous infusion of glucagon-like peptide 1 lowers plasma glucose and reduces appetite in type 2 diabetic patients. Diabetes Care. 1999;22:1137-1143.
10. Nauck MA, Wollschlager D, Werner J, et al. Effects of subcutaneous glucagon-like peptide 1 (GLP-1[7-36 amide]) in patients with NIDDM. Diabetologia. 1996;39:1546-1553.
11. Holst JJ. Glucagon-like peptide-1: from extract to agent. The Claude Bernard Lecture, 2005. Diabetologia. 2006;49:253-260.
12. Kolterman OG, Kim DD, Shen L, et al. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health-Syst Pharm. 2005;62:173-181.
13. Amylin Pharmaceuticals, Inc. Byetta (exenatide) package insert. San Diego, CA; 2009. Available from http://pi.lilly.com/us/byetta-pi.pdf. Accessed August 24, 2010.
14. Harder H, Nielsen L, Thi T, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004;27:1915-21.
15. Visboll T, Zdravkovic M, Le-Thi T, et al. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as montherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type diabetes. Diabetes Care. 2007;30:1608-1610.
16. Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211). Diabetes Care. 2004;27:1335-1342.
17. Degn KB, Juhl CB, Sturis J, et al. One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and α- and β-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes. 2004;53:1187-194.
18. Juhl CB, Hollingdal M, Sturis J, et al. Bedtime administration of NN2211, a long-acting GLP-derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Diabetes. 2002;51:424-429.
19. Elbrond B, Jakobsen G, Larsen S, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care. 2002;25:1398-1404.
20. Chang AM, Jakobsen G, Sturis J, et al. The GLP-1 derivative NN2211 restores β-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes. 2003;52:1786-1791.
21. Pratley R, Nauck M, Bailey T, et al. Liraglutide versus sitagliptan for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomized, parallel-group, open-label trial. Lancet. 2010;375:1447-1456.
22. Zinman B, Gerich J, Buse JB, et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met + TZD). Diabetes Care. 2009;32:1224-1230.
23. Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 mono): a randomized, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009;373:473-481.
24. Novo Nordisk A.S. Victoza (liraglutide) package insert. Princeton, NJ; 2010. Available from http://www.victoza.com/pdf/Victoza_ComboPI_5.24.pdf. Accessed August 24, 2010.
25. Meece J. Pharmacokinetics and pharmacodynamics of liraglutide, a long-acting, potent glucagon-like peptide-1 analog. Pharmacotherapy. 2009;29: 33S-42S.
26. Agerso H, Jensen LB, Elbrond B Rolan P, Zdravkovic M. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia. 2002;45: 195-202.
27. Bjornsdottir I, Olsen A, Larsen U, et al. Metabolism and excretion of the once-daily human GLP-1 analogue liraglutide in healthy subject and its in vitro degradation by dipeptidyl peptidase IV and neutral endopeptidase. Diabetologia. 2008;51:S356. Abstract 891.
28. Damholt B, Golor G, Wierich W, Pedersen P, Ekblom M, Zdravkovic M. An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. J Clin Pharmacol. 2006;46:635-641.
29. Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M. Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol. 2009;68:898-905.
30. Flint A, Nazzal K, Jagielski P, Hindsberger C, Zdravkovic M. Influence of hepatic impairment on pharmacokinetics of the human GLP-1 analogue, liraglutide. Br J Clin Pharmacol. 2010;70(6):807-814.
31. Moretto TJ, Milton DR, Ridge TD, et al. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008;30:1448-1460.
32. Buse JB, Henry RR, Han J, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004;27:2628-2635.
33. DeFronzo RA, Ratner RE, 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. 2005;28:1092-1100.
34. Kendall DM, Riddle MC, 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. 2005;28:1083-1091.
35. Zinman B, Hoogwerf B, Garcia SD, et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes. Ann Intern Med. 2007;146:477-485.
36. Heine RJ, Van Gaal LF, Johns D, et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes. Ann Intern Med. 2005;143:559-569.
37. Nauck MA, Duran S, Johns KD, et al. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who are suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia. 2007;50:259-267.
38. Barnett AH, Burger J, Johns D, et al. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial. Clin Ther. 2007; 29(11):2333-2348.
39. Klonoff D, Buse J, Nielsen L, et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008;24:275-286.
40. Marre M, Shaw J, Brandle M, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glyceamic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1SU). Diabet Med. 2009;26:268-278.
41. Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with merformin, in type 2 diabetes. Diabetes Care. 2009;32:84-90.
42. Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs. insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met + SU): a randomized controlled trial. Diabetologia. 2009;52:2046-2055.
43. Buse JB, Rosenstock J, Sesti G, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomized, parallel-group, multinational, open label trial (LEAD-6). Lancet. 2009;374:39-47.
44. Zdravkovic M, Ekblom M, Bronsted L, Vouis J, Lennernas H, Malm-Erjefalt M. The effect of liraglutide on the absorption pharmacokinetics of concomitant oral drugs with different solubility and permeability properties in healthy subjects. Diabetologia. 2008;51:S355. Abstract 890.
45. Soon D, Kothare PA, Linnebjerg H, et al. Effect of exenatide on the pharmacokinetics and pharmacodynamics of warfarin in healthy Asian men. J Clin Pharmacol. 2006;46:1179-1187.
46. Nathan DM, Buse JB, Davidson MB, et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. Diabetes Care. 2009;32:193-203.
47. Rodbard HW, Jellinger PS, Davidson JA, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabtes mellitus: an algorithm for glycemic control. Endocr Pract. 2009;15(6):540-559.