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Glucagon-like peptide analogues for type 2 diabetes mellitus

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Shyangdan, Deepson S., Royle, Pamela, Clar, C., Sharma, Pawana, Waugh, Norman and Snaith, Ailsa. (2011) Glucagon-like peptide analogues for type 2 diabetes mellitus. Cochrane Database of Systematic Reviews (No.10). CD006423. ISSN 1469-493X

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Official URL: http://dx.doi.org/10.1002/14651858.CD006423.pub2

Abstract

Background Glucagon-like peptide analogues are a new class of drugs used in the treatment of type 2 diabetes that mimic the endogenous hormone glucagon-like peptide 1 (GLP-1). GLP-1 is an incretin, a gastrointestinal hormone that is released into the circulation in response to ingested nutrients. GLP-1 regulates glucose levels by stimulating glucose-dependent insulin secretion and biosynthesis, and by suppressing glucagon secretion, delayed gastric emptying and promoting satiety. Objectives To assess the effects of glucagon-like peptide analogues in patients with type 2 diabetes mellitus. Search strategy Studies were obtained from electronic searches of The Cochrane Library (last search issue 1, 2011), MEDLINE (last search March 2011), EMBASE (last search March 2011), Web of Science (last search March 2011) and databases of ongoing trials. Selection criteria Studies were included if they were randomised controlled trials of a minimum duration of eight weeks comparing a GLP-1 analogue with placebo, insulin, an oral anti-diabetic agent, or another GLP-1 analogue in people with type 2 diabetes. Data collection and analysis Data extraction and quality assessment of studies were done by one reviewer and checked by a second. Data were analysed by type of GLP-1 agonist and comparison treatment. Where appropriate, data were summarised in a meta-analysis (mean differences and risk ratios summarised using a random-effects model). Main results Seventeen randomised controlled trials including relevant analyses for 6899 participants were included in the analysis. Studies were mostly of short duration, usually 26 weeks. In comparison with placebo, all GLP-1 agonists reduced glycosylated haemoglobin A1c (HbA1c) levels by about 1%. Exenatide 2 mg once weekly reduced HbA1c more than exenatide 10 mu g twice daily, sitagliptin and pioglitazone. Liraglutide 1.8 mg reduced HbA1c by 0.33% more than exenatide 10 mu g twice daily. Liraglutide led to similar improvements in HbA1c compared to sulphonylureas but reduced it more than sitagliptin and rosiglitazone. Both exenatide and liraglutide led to greater weight loss than most active comparators, including in participants not experiencing nausea. Hypoglycaemia occurred more frequently in participants taking concomitant sulphonylurea. GLP-1 agonists caused gastrointestinal adverse effects, mainly nausea. These adverse events were strongest at the beginning and then subsided. Beta-cell function was improved with GLP-1 agonists but the effect did not persist after cessation of treatment. None of the studies was long enough to assess long-term positive or negative effects. Authors' conclusions GLP-1 agonists are effective in improving glycaemic control.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Medicine > Warwick Medical School > Warwick Evidence Faculty of Medicine > Warwick Medical School > Health Sciences
Library of Congress Subject Headings (LCSH):	Non-insulin-dependent diabetes -- Treatment, Glucagon-like peptide 1
Journal or Publication Title:	Cochrane Database of Systematic Reviews
Publisher:	John Wiley & Sons Ltd.
ISSN:	1469-493X
Book Title:	Cochrane Database of Systematic Reviews
Date:	2011
Number:	No.10
Page Range:	CD006423
Identification Number:	10.1002/14651858.CD006423.pub2
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Funder:	University of Aberdeen. Dept. of Public Health, Warwick Medical School. Warwick Evidence
References:	A - Rosenstock 2009 {published data only} Rosenstock J, Reusch J, Bush M, Yang F, Stewart M. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes. Diabetes Care 2009;32(10): 1880–6. E - Bergenstal 2010 {published data only} Bergenstal RM, Wysham C, MacConell L, Malloy J, Walsh B, Yan P, et al.Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet Aug 2010;376:431–9. E - Blevins 2011 {published data only} Blevins T, Pullman J, Malloy J, Yan P, Taylor K, Schulteis C, et al.DURATION-5: Exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. The Journal of Clinical Endocrinology and Metabolism 2011;96 (5):1301–10. E - Diamant 2010 {published data only} Diamant M, Van GL, Stranks S, Northrup J, Cao D, Taylor K, et al.Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet 2010;375:2234–43. E - Drucker 2008 {published data only} Best JH, Boye KS, Rubin RR, Cao D, Kim TH, Peyrot M. Improved treatment satisfaction and weight-related quality of life with exenatide once weekly or twice daily. Diabetic Medicine 2009;26(7):722–8. Best JH, Rubin RR, Zhuang D, Velez F, Kim T, Peyrot M. Higher diabetes treatment satisfaction associated with improved glucose control for both exenatide once weekly and twice daily. Diabetes 2008;57:A520. ∗ Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, et al.Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study.[see comment]. Lancet 2008;372(9645):1240–50. L - Kaku 2010 {published data only} Kaku K, Rasmussen MF, Clauson P, Seino Y. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obesity and Metabolism 2010;12:341–7. L - LEAD 1 Marre 2009 {published data only} Marre M, Shaw J, Brändle M, BebakarWMW, Kamaruddin NA, Strand J, et al.Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). DiabeticMedicine 2009; 26:268–78. L - LEAD 2 Nauck 2009 {published data only} Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, et al.Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009; 32(1):84–90. L - LEAD 4 Zinman 2009 {published data only} Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, 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(7):1224–30. L - LEAD 5 Russell-J 2009 {published data only} Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, 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 randomised controlled trial. Diabetologia 2009;52:2046–55. L - LEAD 6 Buse 2009 {published data only} Buse J, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, et al.Switching from twice-daily exenatide to oncedaily liraglutide improves glycemic control in T2D on oral agents. American Diabetes Association. 2009:591–P. ∗ Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, et al.Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD- 6).[see comment]. Lancet 2009;374(9683):39–47. L - Pratley 2010 {published data only} Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, et al.Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallelgroup, open-label trial. Lancet 2010;375:1447–56. L - Yang 2010 {published data only} Yang W, Chen L, Ji Q, Liu X, Ma J, Tandon N, et al.Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial. Diabetes, Obesity and Metabolism Jan 2011;13 (1):81–88. Lixi - Ratner 2010 {published data only} Ratner RE, Rosenstock J, Boka G, DRI6012 Study Investigators. Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial. Diabetic Medicine 2010;27(9):1024–32. LY2189265 -Umpierrez 2011 {published data only} Umpierrez GE, Blevins T, Rosenstock J, Cheng C, Anderson JH, Bastyr EJ 3rd, EGO Study Group. The effects of LY2189265, a long-acting glucagon-like peptide-1 analog, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study. Diabetes, Obesity and Metabolism Jan 2011;13: 418–25. T - Nauck 2009 {published data only} Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebocontrolled study. Diabetes Care 2009;32(7):1237–43. T- Ratner 2010 {published data only} Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabetic Medicine 2010;27:556–62. Abraham 2002 Abraham EJ, Leech CA, Lin JC, Zulewski H, Habener JF. Insulinotropic hormone glucagon-like peptide-1 differentiation of human pancreatic islet-derived progenitor cells into insulin-producing cells. Endocrinology 2002;143 (8):3152–61. ADA 1997 American Diabetes Association. Report on the Expert Committee on the Diagnosis and Classication of Diabetes Mellitus. Diabetes Care 1997;20(Suppl 1):S5–20. ADA 1999 The Expert Committee on the Diagnosis and Classication of Diabetes Mellitus. Report of the Expert Committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 1999;22(Suppl 1):S5–19. Amori 2007 Amori RE, Lau J, Pittas, AG. Efficacy and safety of incretin therapy in type 2 diabetes. Journal of the American Medical Association 2007;298(2):194–206. Baggio 2004 Baggio LL, Huang Q, Brown TJ, Drucker DJ. A recombinant human glucagon-like peptide (GLP)-1- albumin protein (albugon) mimics peptidergic activation of GLP-1 receptor-dependent pathways coupled with satiety, gastrointestinal motility, and glucose homeostasis. Diabetes 2004;53(9):2492–500. Barnett 2009 Barnett AH. New treatments in type 2 diabetes: a focus on the incretin-based therapies. Clinical Endocrinology 2009; 70:343–53. Butler 2010 Butler PC, Matveyenko AV, Dry S, Bhushan A, Elashoff R. Glucagon-like peptide-1 therapy and the exocrine pancreas: innocent bystander or friendly fire?. Diabetologia 2010;53: 1–5. Dore 2011 Dore DD, Bloomgren GL,WentenM,Hoffman C, Clifford CR, Quinn SG, et al.A cohort study of acute pancreatitis in relation to exenatide use. Diabetes, Obesity and Metabolism Jun 2011;13(6):559–66. EMEA 2009 EMEA. Assessment report for Victoza (liraglutide). http:// www.emea.europa.eu/humandocs/PDFs/EPAR/victoza/H- 1026-en6.pdf accessed 10 March 2010. Farilla 2003 Farilla L, Bulotta A, Hirshberg B, Li CS, Khoury N, Noushmehr H, et al.Glucagon-like peptide 1 inhibits cell apoptosis and improves glucose responsiveness of freshly isolated human islets.[see comment]. Endocrinology 2003; 144(12):5149–58. FDA 2008 FDA. Information for Healthcare Professionals: Exenatide (marketed as Byetta). http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ ucm124713.htm accessed 10 March 2010. FDA 2009 FDA. Byetta (exenatide) prescribing information. http: //www.accessdata.fda.gov/drugsatfda˙docs/label/2009/ 021773s9s11s18s22s25lbl.pdf accessed 10 March 2010. FDA 2009 (kidney function) FDA. Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta). http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ ucm188656.htm accessed 10 March 2010. FDA 2009 (safety update) FDA. Byetta Safety Update for Healthcare Professionals. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ ucm190406.htm accessed 10 March 2010. Girman 2010 Girman CJ, Kou TD, Cai B, Alexander CM, O’Neill EA, Williams-Herman DE, et al.Patients with type 2 diabetes mellitus have higher risk for acute pancreatitis compared with those without diabetes. Diabetes Obesity and Metabolism Sep 2010;12(9):766–71. Higgins 2002 Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Statistics in Medicine 2002;21:1539–58. Higgins 2003 Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analysis. BMJ 2003;327: 557–60. Higgins 2011 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org. Journal Watch 2011 Journal Watch. FDA Reminds Clinicians of Liraglutide’s Risks for Pancreatitis and Cancer. http:/ /firstwatch.jwatch.org/cgi/content/full/2011/614/2?q= topic˙diabetes accessed 17 June 2011. Kaku 2010 Kaku K, Rasmussen MF, Clauson P, Seino Y. Improved glycaemic control with minimal hypoglycaemiaand no weight change with the once-daily humanglucagon-like peptide-1 analogue liraglutide as add-onto sulphonylurea in Japanese patients with type 2 diabetes. Diabetes, Obesity and Metabolism 2010;12:341-7. Li 2003 Li Y, Hansotia T, Yusta B, Ris F, Halban PA, Drucker DJ. Glucagon-like peptide-1 receptor signaling modulates beta cell apoptosis. The Journal of Biological Chemistry 2003;278 (1):471–8. Loh and Clement 2007 Loh JA, Clement SC. Efficacy of exenatide therapy over 12 months in a “real world” setting. Diabetes 2007;56:A152. Moher 2009 Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA group. Preferred reporting items for systematic reviews and meta-analysis: the PRISMA statement. British Medical Journal 2009;339:b2535. Monami 2009 Monami M, Marchionni N, Mannucci E. Glucagon like peptide-1 receptor agonists in type 2 diabetes: a metaanalysis of randomized clinical trials. European Journal of Endocrinology 2009;160:909–17. Nathan 2009 Nathan DM, Buse JB, DavidsonMB, Ferrannini E,Holman RR, Sherwin R, et al.American Diabetes Association, European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32(1):193–03. Nauck 1993 Nauck MA, Kleine N, Orskov C, Holst JJ, Willms B, Creutzfeldt W. Normalization of fasting hyperglycaemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Diabetologia 1993;36(8):741–4. Nauck 2002 Nauck MA, Heimesaat MM, Behle K, Holst JJ, Nauck MS, Ritzel R, et a. Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycaemic clamp experiments in healthy volunteers. The Journal of Clinical Endocrinology and Metabolism 2002; 87(3):1239–46. NICE CG66 2008 National Collaborating Centre for Chronic Conditions. Type 2 diabetes: national clinical guideline for management in primary and secondary care. London: Royal College of Physicians 2008; Vol. http://www.nice.org.uk/nicemedia/ pdf/CG66FullGuideline0509.pdf. NICE CG87 2009 National Institute for Health and Clinical Excellence. Type 2 diabetes: the management of type 2 diabetes. NICE clinical guideline 87 2009; Vol. http://www.nice.org.uk/ cg87. NICE TA203 2010 National Institute for Health and Clinical Excellence. Liraglutide for the treatment of type 2 diabetes mellitus. NICE technology appraisal guidance 203. http:// guidance.nice.org.uk/TA203 2010. Norris 2009 Norris SL, Lee N, Thakurta S, Chan BKS. Exenatide efficacy and safety: a systematic review. Diabetic Medicine 2009;26:837–46. Pratley 2008 Pratley RE. Overview of glucagon-like peptide-1 analogs and dipeptidyl peptidase-4 inhibitors for type 2 diabetes. Medscape Journal of Medicine 2008;10(7):171. Shyangdan 2010 Shyangdan DS, Royle PL, Clar C, Sharma P, Waugh NR. Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis. BMC Endocrine Disorders 2010;10:20. Shyangdan 2011 Shyangdan D, Cummins E, Royle P, Waugh N. Liraglutide for the treatment of type 2 diabetes. Health Technology Assessment 2011;15(Suppl. 1):75–84. Turner 1996 Turner RC, Holman RR. The UK Prospective Diabetes Study. UK Prospective Diabetes Study Group. Annals of Medicine 1996;28(5):439–44. UKPDS 16 UKPDS Study Group. UKPDS 16. Overview of 6 years’ therapy of type II diabetes: a progressive disease. UK Prospective Diabetes Study Group. Diabetes 1995;44: 1249–58. Waugh 2010 Waugh N, Cummins E, Royle P, Clar C, Marien M, Richter B, et al.Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation. Health Technology Assessment July 2010;14(36):1–248. WHO 1998 Alberti KM, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its compliactions. Part I: diagnosis and classification of diabetes mellitus. Provisional report of a WHO consultation. Diabetic Medicine 1998;15:539–53. Xu 1999 Xu G, Stoffers DA, Habener JF, Bonner-Weir S. Exendin- 4 stimulates both beta-cell replication and neogenesis, resulting in increased beta- cell mass and improved glucose tolerance in diabetic rats. Diabetes 1999;48(12):2270–6.
URI:	http://wrap.warwick.ac.uk/id/eprint/40337