Efficacy and safety of insulin in type 2 diabetes: Meta-analysis of randomised controlled trials

BMC Endocrine Disorders

Volumn 16, Issue 1, 2016, Pages

  Erpeldinger, Sylvie ^a   Rehman, Michaela B ^b   Berkhout, Christophe ^c   Pigache, Christophe ^a   Zerbib, Yves ^a,d   Regnault, Francis ^a   Guérin, Emilie ^a   Supper, Irène ^a   Cornu, Catherine ^a,e,f   Kassaï, Behrouz ^a,e,f   Gueyffier, François ^a,f   Boussageon, Rémy ^g  

^a UNIVERSITÉ LYON 1   (France)

^b POITIERS UNIVERSITY HOSPITAL   (France)

^c UNIV LILLE   (France)

^d University Claude Bernard   (France)

^e Inserm   (France)

^f HOSPICES CIVILS DE LYON   (France)

^g UNIVERSITÉ DE POITIERS   (France)

Author keywords

Hypoglycaemic drugs; Insulin; Meta analysis; Morbidity; Mortality; Randomised Controlled Trials; Type 2 Diabetes Mellitus

Indexed keywords

ANTIDIABETIC AGENT; INSULIN; PLACEBO;

ARTICLE; CLINICAL EFFECTIVENESS; DIET THERAPY; DRUG EFFICACY; DRUG SAFETY; HUMAN; HYPOGLYCEMIA; META ANALYSIS; MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TREATMENT PLANNING; WEIGHT GAIN; COMPLICATION; DIABETES MELLITUS, TYPE 2;

DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84979086273     PISSN: None     EISSN: 14726823     Source Type: Journal    
DOI: 10.1186/s12902-016-0120-z     Document Type: Article

References (55)

1. http://www.who.int/diabetes/(accessed 12 Jun 2015)
2. The Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose and risk of cause-specific death. N Engl J Med. 2011;364:829-41.
3. Rensing KL, Reuwer AQ, Arsenault BJ, Von der Thûsen JH, Hoekstra JB, Kastelein JJ, Twickler TB. Reducing cardiovascular disease risk in patients with type 2 diabetes and concomitant macrovascular disease: can insulin be too much of a good thing? Diabetes Obes Metab. 2011;13:1073-87.
4. Currie CJ, Johnson JA. The safety profile of exogenous insulin in people with type 2 diabetes: justification for concern. Diabetes Obes Metab. 2012;14:1-4.
5. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2015;58:429-42.
6. NICE Guidance: December 2015. www.nice.org.uk/guidance/ng28. Accessed 12 June 2015
7. Boussageon R, Supper I, Bejan-Angoulvant T, Kellou N, Cucherat M, Boissel JP, Kassai B, Moreau A, Gueyffier F, Cornu C. Reappraisal of metformin efficacy in the treatment of type 2 diabetes: a meta-analysis of randomised controlled trials. PLoS Med. 2012;9(4), e1001204.
8. Monami M, Genovese S, Mannucci E. Cardiovascular safety of sulfonylureas: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2013;15:938-53.
9. Higgins J P T, Altman D G, Gøtzsche P C, Jüni P, Moher D, Oxman A D, Savovic J, Schulz K F, Weeks L, Sterne J A C, Cochrane Bias Methods Group, Cochrane Statistical Methods Group: The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011, 343 doi: http://dx.doi. org/10.1136/bmj.d5928.
10. UGDP. Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. VIII. Evaluation of insulin therapy: final report. Diabetes. 1982;31:1-81.
11. UK Prospective Diabetes Study (UKPDS) Group. 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;352:837-53.
12. Nathan DM. Some answers, more controversy, from UKPDS. Lancet. 1998;352:832-3.
13. Ewart RM. The case against agressive treatment of type 2 diabetes: critique of the UK prospective diabetes study. BMJ. 2001;323:854-8.
14. McCormack J, Greenhalgh T. Seeing what you want to see in randomised controlled trials: versions and perversions of UKPDS data. BMJ. 2000;320:1720-3.
15. Boussageon R, Supper I, Erpeldinger S, Cucherat M, Bejan-Angoulvant T, Kassai B, Cornu C, Gueyffier F. Are concomitant treatments confounding factors in randomized controlled trials on intensive blood-glucose control in type 2 diabetes? A systematic review. BMC Med Res Methodol. 2013;13:107.
16. Halimi S, Raskin P, Liebl A, Kawamori R, Fulcher G, Yan G. Efficacy of biphasic insulin aspart in patients with type 2 diabetes. Clin Ther. 2005;27(suppl B):S57-74.
17. Garg R, Hurwitz S, Turchin A, Trivedi A. Hypoglycemia, with or without insulin therapy, is associated with increased mortality among hospitalized patients. Diabetes Care. 2013;36:1107-10.
18. ACCORD study. Gerstein HC, Miller ME, Byington RP, GoffDC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545-59.
19. ADVANCE Study. Patel A, MacMahon S, Chalmers Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, De Galam BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-72.
20. Bonds DE, Miller ME, Bergenstal RM, Buse JB, Byington RP, Cutler JA, et al. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010;340:b4909.
21. Zoungas S, Patel A, Chalmers J, de Galam BE, Li Q, Billot L, Woodward M, Ninomiya T, Neal B, MacMahon S, Grobbee DE, Kengne AP, Marre M, Heller S. Severe hypoglycaemia and risks of vascular events and death. N Eng J Med. 2010;363:1410-8.
22. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365:2002-12.
23. Geller AI, Shebab N, Lovegrove MC, Kegler SR, Weidenbach KN, Ryan GJ, Budnitz DS. National estimates of insulin-related hypoglycaemia and errors leading to emergency department visits and hospitalizations. JAMA Intern Med. 2014;174:678-86.
24. Whitmer RA, Karter AJ, Yaffe K, Quesenberry Jr CP, Selby JV. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA. 2009;301:1565-72.
25. Liu SC, Tu YK, Chien MN, Chien KL. 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;14:810-20.
26. Ruige JB, Assendelft WJ, Dekker JM, Kostense PJ, Heine RJ, Bouter LM. Insulin and risk of cardiovascular disease: a meta-analysis. Circulation. 1998;97:996-1001.
27. Gamble JM, Simpson SH, Eurich DT, Majumdar SR, Johnson JA. Insulin use and increased risk of mortality in type 2 diabetes: a cohort study. Diabetes Obes Metab. 2010;12:47-53.
28. Bowker SL, Majumdar SR, Veugelers P, Johnson JA. Increased cancer-related mortality for patients with type 2 diabetes who use sulphonylureas or insulin. Diabetes Care. 2006;29:254-8.
29. Pollak M. Insulin and insulin-like growth factor signaling in neoplasia. Nat Rev Cancer. 2008;8:915-28.
30. Draznin B. Mitogenic action of insulin: friend, foe or "frenemy'? Diabetologia. 2010;53:229-33.
31. Holden SE, Gale EA, Jenkins-Jones S, Currie CJ. How many people inject insulin? UK estimates from 1991 to 2010. Diabetes Obes Metab. 2014;16:553-9.
32. Alvarsson M, Sundkvist G, Lager I, Henricsson M, Berntorp K, Ferngvist-Forbes E, Steen L, Westermark G, Westermark P, Orn T, Grill V. Beneficial effects of insulin versus sulphonylurea on insulin secretion and metabolic control in recently diagnosed type 2 diabetic patients. Diabetes Care. 2003;26:2231-7.
33. Aschner P, Chan J, Owens DR, Picard S, Wang E, Dain M-P, Pilorget V, Echtay A. Fonseca: insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012;379:2262-9.
34. Bunck MC, Diamant M, Cornér A, Eliasson B, Malloy JL, Shaginian RM, Deng W, Kendall DM, Taskinen MR, Smith U, Ykri-Jârvinen H, Heine RJ. One-year treatment with exenatide improves ß-cell function, compared with insulin glargine, in metformin treated type 2 diabetic patients. Diabetes Care. 2009;32:762-8.
35. Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009;11:1153-62.
36. Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. 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.
37. Gallwitz B, Böhmer M, Segiet T, Môlle A, Milek K, Becker B, Helsberg K, Petto H, Peters N, Bachmann O. Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia. Diabetes Care. 2011;34:604-6.
38. Gerstein HC, Yale JF, Harris SB, Issa M, Stewart JA, Dempsey E. A randomized trial of adding insulin glargine vs. avoidance of insulin in people with Type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with Insulin Glargine for Hyperglycaemia Treatment) Study. Diabet Med. 2006;23:736-42.
39. Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012; 367(4):319-28.
40. Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Aved A, Pieroni L, Clement K, Grimaldi A. Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes. Diabetes Res Clin Pract. 2009;86:37-43.
41. Heine RJ, Van Gaal LF, Johns D, Mihhm MJ, Widel MH, Brodows RG. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2009;143:559-69.
42. Hollander P, Raslova K, Skjøth TV, Råstam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011;13:268-75.
43. Nauck MA, Duran S, KimD, Johns D, Northrup J, Festa A, Brodows R, Trautmann M. 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 non-inferiority study. Diabetologia. 2007;50:259-67.
44. Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R, T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013;30:109-13.
45. Reynolds LR, Kingsley FJ, Karounos DG, Tannock LR. Differential effects of rosiglitazone and insulin glargine on inflammatory markers, glycemic control, and lipids in type 2 diabetes. Diabetes Res Clin Pract. 2007;77:180-7.
46. Rosenstock J, Sugimoto D, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care. 2006;29:554-9.
47. United Kingdom Prospective Diabetes Study 24. a 6-year, randomized, controlled trial comparing sulfonylurea, insulin, and metformin therapy in patients with newly diagnosed type 2 diabetes that could not be controlled with diet therapy. United Kingdom Prospective Diabetes Study Group. Ann Intern Med. 1998;128:165-75.
48. Blicklé J-F, Hancu N, Piletic M, Profozic V, Shestakova M, Dain M-P, Jacqueminet S, Grimaldi A. Insulin glargine provides greater improvements in glycaemic control vs. intensifying lifestyle management for people with type 2 diabetes treated with OADs and 7-8 % A1c levels. The TULIP study. Diabetes Obes Metab. 2009;11:379-86.
49. Russel-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simo R. 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.
50. The University Group Diabetes Program. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. V. Evaluation of pheniformin therapy. Diabetes. 1975;24 Suppl 1:65-184.
51. Phenformin and vascular complications of diabetes. Med Lett Drugs Ther. 1972;14:1-2.
52. Schor S. The University Group Diabetes Program. A statistician looks at the mortality results. JAMA. 1971;217:1671-5.
53. Cornfield J. The University Group Diabetes Program. A further statistical analysis of the mortality findings. JAMA. 1971;217:1676-87.
54. Feinglos MN, Bethel MA. Therapy of type 2 diabetes, cardiovascular death, and the UGDP. Am Heart J. 1999;138:S346-52.
55. Goldner MG, Knatterud GL, Prout TE. Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. 3. Clinical implications of UGDP results. JAMA. 1971;218:1400-10.