Impact of Newer Medications for Type 2 Diabetes on Body Weight

Current Obesity Reports

Volumn 2, Issue 2, 2013, Pages 134-141

  Pedersen, Sue D ^a  

^a LMC Endocrinology Centre Calgary   (Canada)

Author keywords

Amylin; Body weight; Canagliflozin; Colesevelam; Dapagliflozin; Exenatide; GLP 1; Incretins; Linagliptin; Liraglutide; Newer medications; Obesity; Pramlintide; Saxagliptin; Sitagliptin; Sodium glucose transporter 2; Type 2 diabetes mellitus; Vildagliptin; Weight loss

Indexed keywords

CANAGLIFLOZIN; COLESEVELAM; DAPAGLIFLOZIN; EXENDIN 4; GLIPIZIDE; INSULIN; LINAGLIPTIN; LIRAGLUTIDE; METFORMIN; METRELEPTIN; PLACEBO; PRAMLINTIDE; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA; TETRAHYDROLIPSTATIN; VILDAGLIPTIN;

BLADDER CANCER; BODY WEIGHT; BREAST CANCER; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG WITHDRAWAL; EVENING DOSAGE; GASTROINTESTINAL DISEASE; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; LIVER TOXICITY; META ANALYSIS (TOPIC); MORNING DOSAGE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; RISK FACTOR; SIDE EFFECT; STOMACH EMPTYING; WEIGHT GAIN; WEIGHT REDUCTION;

EID: 84887479648     PISSN: None     EISSN: 21624968     Source Type: Journal    
DOI: 10.1007/s13679-012-0045-4     Document Type: Review

References (78)

1. National Diabetes Statistics, 2011: Fast Facts on Diabetes. National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. http://diabetes. niddk. nih. gov/dm/pubs/statistics/ Accessed online 8. Sep. 2012.
2. Prevalence of Obesity in the United States, 2009-2010: NCHS Data Brief. http://www. cdc. gov/nchs/data/databriefs/db82. pdf January 2012. Accessed online 8. sept. 2012.
3. Hu FB, Manson JE, Stampfer M, et al. Diet, lifestyle, and the risk of type 2 diabetes mellitus in women. N Engl J Med. 2001; 345: 790-7.
4. Eeg-Olofsson K, Cederholm J, Nilsson PM, et al. Risk of cardiovascular disease and mortality in overweight and obese patients with type 2 diabetes: an observational study in 13, 087 patients. Diabetologia. 2009; 52: 65-73.
5. •• Meneghini LF, Orozco-Beltran D, Khunti K, et al. Weight beneficial treatments for type 2 diabetes. J Clin Endocrinol Metab. 2011; 96(11): 3337-53. This paper discusses treatments for T2DM treatment that have advantages from a weight management perspective.
6. Schmid C, Krayenbühl P, Wiesli P. Increased insulin dose requirement of long-acting insulin analogues in obese patients with type 2 diabetes. Diabetologia. 2009; 52: 2668-9.
7. Pani LN, Nathan DM, Grant RW. Clinical predictors of disease progression and medication initiation in untreated patients with type 2 diabetes and A1C less than 7 %. Diabetes Care. 2008; 31: 386-90.
8. Hermansen K, Mortensen LS. Body weight changes associated with antihyperglycaemic agents in type 2 diabetes mellitus. Drug Saf. 2007; 30: 1127-42.
9. Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010; 303(14): 1410-8.
10. United Kingdom Prospective Diabetes Study (UKPDS) 13. Relative efficacy of randomy allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years. BMJ. 1995; 310: 83-9.
11. Liu S-C, Chien M-N, Tu Y-K, Chien K-L. Effect of antidiabetic agents added to metformin on glycaemic control, hypoglycaemia and weight change in patients with type 2 diabetes: A network meta-analysis. Diabetes Obes Metab. 2012; 14(9): 810-20.
12. American Diabetes Association. Standards of medical care in diabetes-2010. Diabetes Care. 2010; 33 Suppl 1: S11-61.
13. Rydén L, Standl E, Bartnik M, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J. 2007; 28: 88-136.
14. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Canadian Diabetes Association 2008 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes. 2008; 32 suppl 1: S1-201.
15. DeFronzo RA, Goodman AM. Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus - The Multicenter Metformin Study Group. N Engl J Med. 1995; 333: 541-9.
16. Kahn SE, Haffner SM, Heis MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006; 355: 2427-43.
17. Schernthaner G, Matthews DR, Charbonnel B, et al. Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus: a double-blind, randomized trial. J Clin Endocrinol Metab. 2004; 89(12): 6068-76.
18. Dungan KM, Buse JB. Glucagon-like peptide 1-based therapies for type 2 diabetes: a focus on exenatide. Clin Diabetes. 2005; 23: 56-62.
19. Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology. 2007; 132: 2131-57.
20. Nauck MA, Kleine N, Orskov C, et al. Normalization of fasting hyperglycaemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1993; 36: 741-4.
21. Nauck MA, Niedereichholz U, Ettler R, et al. Glucagon-like peptide 1 inhibition of gastric emptying outweighs its insulinotropinc effects in healthy humans. Am J Physiol. 1997; 273(5 Pt 1): E981-8.
22. Williams DL. Minireview: finding the sweet spot: peripheral versus central glucagon-like peptide 1 action in feeding and glucose homeostasis. Endocrinology. 2009; 150: 2997-3001.
23. Toft-Nielsen MB, Damholt MB, Madsbad S, et al. Determinants of the impaired secretion of glucagon-like peptide-1 in type 2 diabetic patients. J Clin Endocrinol Metab. 2001; 86: 3717-23.
24. Nauck M, Stöckmann F, Ebert R, Creutzfeldt W. Reduced incretin effect in type 2 (non-insulin dependent) diabetes. Diabetologia. 1986; 29: 46-52.
25. Vilsbøll T, Knop FK, Krarup T, et al. The pathophysiology of diabetes involves a defective amplification of the late-phase insulin response to glucose by glucose-dependent insulinotropic polypeptide-regardless of etiology and phenotype. J Clin Endocrinol Metab. 2003; 88: 4897-903.
26. Koliaki C, Doupis J. Incretin-based therapy: a powerful and promising weapon in the treatment of type 2 diabetes mellitus. Diabetes Ther. 2011; 2(2): 101-21.
27. Lind M. Incretin therapy and its effect on body weight in patients with diabetes. Prim Care Diabetes. 2012; 6(3): 187-91.
28. •• Cornell S. Differentiating among incretin therapies: a multiple-target approach to type 2 diabetes. J Clin Pharm Ther. 2012. doi: 10. 1111/j. 1365-2710. 2012. 01342. x. This paper compares and contrasts GLP-1 receptor agonists and DPP-4 inhibitors.
29. Aroda VR, Henry RR, Han J, et al. Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review. Clin Ther. 2012; 34(6): 1247-58.
30. Scheen AJ, Charpentier G, Ostgren CJ, et al. Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. Diabetes Metab Res Rev. 2010; 26: 540-9.
31. Pi-Sunyer FX, Schweizer A, Mills D, et al. Efficacy and tolerability of vildagliptin monotherapy in drug-naïve patients with type 2 diabetes. Diabetes Res Clin Pract. 2007; 76: 132-8.
32. Garber AJ, Schweizer A, Baron MA, et al. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007; 9: 166-74.
33. Taskinen MR, Rosenstock J, Tamminen I, et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebocontrolled study. Diabetes Obes Metab. 2011; 13: 65-74.
34. Byetta ™ product monograph. Eli Lilly Canada Inc., Toronto. Available at http://www. glucagon. com/pdfs/ByettaCanadaPM_11Jan2011_pswd. pdf Accessed September 2012.
35. Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007; 298(2): 194-206.
36. 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(5): 1092-100.
37. Ratner RE, Magges D, Nielsen LL, et al. Long term effets of exenatide therapy over 82 weeks on glycaemic control and weight in overweight metformin-treated patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2006; 8(4): 419-28.
38. Jelsing J, Vrang N, Hansen G, et al. Liraglutide: short-lived effect on gastric emptying- long lasting effects on body weight. Diabetes Obes Metab. 2012; 14: 531-8.
39. Niswender K, Pi-Sunyer X, Buse J, et al. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2012. doi: 10. 1111/j. 1463-1326. 2012. 01673. x.
40. Buse JB, Rosenstock J, Sesti G, 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). Lancet. 2009; 374: 39-47.
41. Bydureon® prescribing information. Amylin Pharmaceuticals, Inc., San Diego. Available at www. documents. bydureon. com/Bydureon_PI. pdf. Accessed September 2012.
42. Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomized, open-label, non-inferiority study. Lancet. 2008; 372: 1240-50.
43. Buse JB, Nauck MA, Forst T, et al. Efficacy and safety of exenatide once weekly versus liraglutide in subjects with type 2 diabetes (DURATION-6): a randomized, open-label study. Diabetologia. 2011; 54 Suppl 1: S38.
44. Barnett AH. Lixisenatide: evidence for its potential use in the treatment of type 2 daibetes. Core Evid. 2011; 6: 67-79.
45. Tzefos M, Harris K, Brackett A. Clinical efficacy and safety of once-weekly glucagon-like peptide-1 agonists in development for treatment of type 2 diabetes mellitus in adult. Ann Pharmacother. 2012; 46(1): 68-78.
46. Clinicaltrials. gov: A randomized controlled clinical triral in type 2 diabetes comparing semaglutide to placebo and liraglutide. Available at http://clinicaltrials. gov/ct2/show/NCT00696657?term=semaglutide& rank=2 Accessed September 2012.
47. Davies M, Pratley R, Hammer M, et al. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011; 28(3): 333-7.
48. Poster M, Zanutto E, McDonald S, et al. A comparison of preferences for two GLP-1 products - liraglutide and exenatide - for the treatment of type 2 diabetes. J Med Econ. 2010; 13(4): 655-61.
49. Davies M, Speight J. Patient-reported outcomes in trials of incretin-based therapies in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012; 14(10): 882-92.
50. Buse J, Bergenstal RM, Glass LC, et al. Add-on of twice-daily exenatide to basal insulin-treated patients with type 2 diabetes: a randomized, controlled Trial. Ann Intern Med. 2011; 154: 103-12.
51. DeVries JH, Bain SC, Rodbard HW, et al. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012; 35(7): 1446-54.
52. Bain SC, DeVries JH, Seufert J, et al. Adding insulin detemir (IDet) to liraglutide and metformin improves glycaemic control with sustained weight reduction and low hypoglycaemia rate: 52 week results. Diabetologia. 2011; 54 Suppl 1: S37.
53. Astrup A, Rossner S, van Gaal L, et al. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009; 374(9701): 1606-16.
54. Astrup A, Carraro R, Finer N, et al. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes. 2012; 36(6): 843-54.
55. Rosenstock J, Klaff LJ, Schwartz S, et al. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care. 2010; 33(6): 1173-5.
56. Dushay J, Gao C, Gopalakrishnan GS, et al. Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes. Diabetes Care. 2012; 35(1): 4-11.
57. Sabino-Silva R, Mori RC, David-Silva A, et al. The Na(+)/glucose cotransporters: from genes to therapy. Braz J Med Biol Res. 2010; 43(11): 1019-26.
58. Patel AK, Fonseca V. Turning glucosuria into a therapy: efficacy and safety with SGLT2 inhibitors. Curr Diab Rep. 2010; 10(2): 101-7.
59. •• Ghosh RK, Ghosh SM, Chawla S, Jasdanwala SA. SGLT2 inhibitors: a new emerging therapeutic class in the treatment of type 2 diabetes mellitus. J Clin Pharmacol. 2012; 52(4): 457-63. This is a thorough review of SGLT2 physiology and clinical development of SGLT2 agents.
60. European Medicines Agency. Summary of opinion (initial authorization) - dapagliflozin. EMA/CHMP/259852/2012. 19 April 2012. Available at http://www. ema. europa. eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002322/WC500125684. pdf. Accessed September 2012.
61. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010; 375: 2223-33.
62. Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011; 34(9): 2015-22.
63. Bolinder J, Ljunggren Ö, Kullberg J, et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012; 97(3): 1020-31.
64. Wilding JP, Woo V, Soler NG, et al. Long-term efficacly of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012; 156(6): 405-15.
65. FDA Briefing Document. NDA 202293. Dapagliflozin Tablets, 5 and 10 mg. Sponsor: Bristol-Myers Squibb. Advisory Committee Meeting. 2011. Jul 19. Available at http://www. fda. gov/downloads/Advisory Committees/CommitteesMeetingMaterials/Drugs/Endocrinologic and Metabolic DrugsAdvisory Committee/UCM262994. pdf. Accessed September 2012.
66. Rosenstock J, Aggarwal N, Polidori D, et al. Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes. Diabetes Care. 2012; 35(6): 1232-8.
67. Younk LM, Mikeladze M, Davis SN. Pramlintide and the treatment of diabetes: a review of the data since its introduction. Expert Opin Pharmacother. 2011; 12(9): 1439-51.
68. Roth JD, Maier H, Chen S, Roland BL. Implications of amylin receptor agonism: integrated neurohormonal mechanisms and therapeutic applications. Arch Neurol. 2009; 66(3): 306-10.
69. Hollander P, Maggs DG, Ruggles JA, et al. Effect of pramlintide on weight in overweight and obese insulin-treated type 2 diabetes patients. Obes Res. 2004; 12(4): 661.
70. Riddle M, Frias J, Zhang B, et al. Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care. 2007; 11: 2794-9.
71. Riddle M, Pencek R, Charenkavanich S, et al. Randomized comparison of pramlintide or mealtime insulin added to basal insulin treatment for patients with type 2 diabetes. Diabetes Care. 2009; 32(9): 1577-82.
72. Symlin(R) [package insert]. San Diego, CA: Amylin Pharmaceuticals; 2008. Available at https://www. symlin. com/pdf/symlin-pi-combined. pdf Accessed September 2012.
73. Amylin and Takeda discontinue development of pramlintide/metreleptin combination treatment for obesity following commercial reassessment of the program. Available at http://www. takeda. com/press/article_42791. html. Accessed September 2012.
74. Rosenstock J, Fonseca VA, Garvey WT, et al. Initial combination therapy with metformin and colesevelam for achievement of glycemic and lipid goals in early type 2 diabetes. Endocr Pract. 2010; 16(4): 629-40.
75. Bays HE. Colesevelam hydrochloride added to background metformin therapy in patients with type 2 diabetes mellitus: a pooled analysis from 3 clinical studies. Endocr Pract. 2011; 17(6): 933-8.
76. Ganda OP. The role of bile acid sequestrants in the management of type 2 diabetes mellitus. Metab Syndr Relat Disord. 2010; 8 Suppl 1: S15-21.
77. Welchol (Colesevelam) prescribing information. Daiichi Sankyo, Inc., Parsippany, New Jersey. Available at http://www. accessdata. fda. gov/drugsatfda_docs/label/2008/021176s017lbl. pdf. Accessed September 2012.
78. Younk LM, Davis SN. Evaluation of colesevelam hydrochloride for the treatment of type 2 diabetes. Expert Opin Drug Metab Toxicol. 2012; 8(4): 515-25.