Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes - PubMed (original) (raw)
Randomized Controlled Trial
. 2007 Oct 25;357(17):1716-30.
doi: 10.1056/NEJMoa075392. Epub 2007 Sep 21.
Affiliations
- PMID: 17890232
- DOI: 10.1056/NEJMoa075392
Free article
Randomized Controlled Trial
Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes
Rury R Holman et al. N Engl J Med. 2007.
Free article
Abstract
Background: Adding insulin to oral therapy in type 2 diabetes mellitus is customary when glycemic control is suboptimal, though evidence supporting specific insulin regimens is limited.
Methods: In an open-label, controlled, multicenter trial, we randomly assigned 708 patients with a suboptimal glycated hemoglobin level (7.0 to 10.0%) who were receiving maximally tolerated doses of metformin and sulfonylurea to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). Outcome measures at 1 year were the mean glycated hemoglobin level, the proportion of patients with a glycated hemoglobin level of 6.5% or less, the rate of hypoglycemia, and weight gain.
Results: At 1 year, mean glycated hemoglobin levels were similar in the biphasic group (7.3%) and the prandial group (7.2%) (P=0.08) but higher in the basal group (7.6%, P<0.001 for both comparisons). The respective proportions of patients with a glycated hemoglobin level of 6.5% or less were 17.0%, 23.9%, and 8.1%; respective mean numbers of hypoglycemic events per patient per year were 5.7, 12.0, and 2.3; and respective mean weight gains were 4.7 kg, 5.7 kg, and 1.9 kg. Rates of adverse events were similar among the three groups.
Conclusions: A single analogue-insulin formulation added to metformin and sulfonylurea resulted in a glycated hemoglobin level of 6.5% or less in a minority of patients at 1 year. The addition of biphasic or prandial insulin aspart reduced levels more than the addition of basal insulin detemir but was associated with greater risks of hypoglycemia and weight gain. (Current Controlled Trials number, ISRCTN51125379 [controlled-trials.com].).
Copyright 2007 Massachusetts Medical Society.
Comment in
- Intention to treat--initiating insulin and the 4-T study.
McMahon GT, Dluhy RG. McMahon GT, et al. N Engl J Med. 2007 Oct 25;357(17):1759-61. doi: 10.1056/NEJMe078196. Epub 2007 Sep 21. N Engl J Med. 2007. PMID: 17890233 No abstract available. - Is biphasic, prandial, or basal insulin best for poorly controlled type 2 diabetes?
[No authors listed] [No authors listed] J Fam Pract. 2008 Feb;57(2):84. J Fam Pract. 2008. PMID: 18254190 No abstract available. - Addition of insulin to oral therapy in type 2 diabetes.
Dağdelen S. Dağdelen S. N Engl J Med. 2008 Mar 13;358(11):1197; author reply 1198. doi: 10.1056/NEJMc073240. N Engl J Med. 2008. PMID: 18337612 No abstract available. - Addition of insulin to oral therapy in type 2 diabetes.
Ilag LL, Martin S, Jacober SJ. Ilag LL, et al. N Engl J Med. 2008 Mar 13;358(11):1197-8; author reply 1198. N Engl J Med. 2008. PMID: 18340664 No abstract available. - Adjunctive prandial or biphasic insulin for type 2 diabetes improved glycaemic control but increased hypoglycaemia and weight gain.
Dinneen SF, Waldron-Lynch F. Dinneen SF, et al. Evid Based Med. 2008 Jun;13(3):77. doi: 10.1136/ebm.13.3.77. Evid Based Med. 2008. PMID: 18515624 No abstract available.
Similar articles
- Three-year efficacy of complex insulin regimens in type 2 diabetes.
Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Holman RR, et al. N Engl J Med. 2009 Oct 29;361(18):1736-47. doi: 10.1056/NEJMoa0905479. Epub 2009 Oct 22. N Engl J Med. 2009. PMID: 19850703 Clinical Trial. - Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia.
Ushakova O, Sokolovskaya V, Morozova A, Valeeva F, Zanozina O, Sazonova O, Zhadanova E, Starceva M, Kazakova E, Saifullina M, Shapiro I, Tarasov A, Al-Tayar B, Starkova N. Ushakova O, et al. Clin Ther. 2007 Nov;29(11):2374-84. doi: 10.1016/j.clinthera.2007.11.017. Clin Ther. 2007. PMID: 18158078 Clinical Trial. - Differences in insulin treatment satisfaction following randomized addition of biphasic, prandial or basal insulin to oral therapy in type 2 diabetes.
Farmer AJ, Oke J, Stevens R, Holman RR. Farmer AJ, et al. Diabetes Obes Metab. 2011 Dec;13(12):1136-41. doi: 10.1111/j.1463-1326.2011.01475.x. Diabetes Obes Metab. 2011. PMID: 21767341 Clinical Trial. - Prandial premixed insulin analogue regimens versus basal insulin analogue regimens in the management of type 2 diabetes: an evidence-based comparison.
Ilag LL, Kerr L, Malone JK, Tan MH. Ilag LL, et al. Clin Ther. 2007 Jun;29(6 Pt 1):1254-70. doi: 10.1016/j.clinthera.2007.07.003. Clin Ther. 2007. PMID: 18036388 Review. - A comparison of biphasic insulin aspart and insulin glargine administered with oral antidiabetic drugs in type 2 diabetes mellitus--a systematic review and meta-analysis.
Rys P, Wojciechowski P, Siejka S, Małecki P, Hak L, Malecki MT. Rys P, et al. Int J Clin Pract. 2014 Mar;68(3):304-13. doi: 10.1111/ijcp.12337. Epub 2014 Jan 28. Int J Clin Pract. 2014. PMID: 24471814 Review.
Cited by
- Practical Guidance on the Use of Premix Insulin Analogs in Initiating, Intensifying, or Switching Insulin Regimens in Type 2 Diabetes.
Wu T, Betty B, Downie M, Khanolkar M, Kilov G, Orr-Walker B, Senator G, Fulcher G. Wu T, et al. Diabetes Ther. 2015 Sep;6(3):273-87. doi: 10.1007/s13300-015-0116-0. Epub 2015 Jun 24. Diabetes Ther. 2015. PMID: 26104878 Free PMC article. - Common standards of basal insulin titration in type 2 diabetes.
Arnolds S, Heise T, Flacke F, Sieber J. Arnolds S, et al. J Diabetes Sci Technol. 2013 May 1;7(3):771-88. doi: 10.1177/193229681300700323. J Diabetes Sci Technol. 2013. PMID: 23759411 Free PMC article. Review. - Early discontinuation and related treatment costs after initiation of Basal insulin in type 2 diabetes patients: a German primary care database analysis.
Anderten H, Dippel FW, Kostev K. Anderten H, et al. J Diabetes Sci Technol. 2015 May;9(3):644-50. doi: 10.1177/1932296814566232. Epub 2015 Jan 7. J Diabetes Sci Technol. 2015. PMID: 25573957 Free PMC article. - How do we continue treatment in patients with type 2 diabetes when therapeutic goals are not reached with oral antidiabetes agents and lifestyle? Incretin versus insulin treatment.
Gallwitz B, Bretzel RG. Gallwitz B, et al. Diabetes Care. 2013 Aug;36 Suppl 2(Suppl 2):S180-9. doi: 10.2337/dcS13-2012. Diabetes Care. 2013. PMID: 23882044 Free PMC article. No abstract available. - 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.
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Inzucchi SE, et al. Diabetologia. 2015 Mar;58(3):429-42. doi: 10.1007/s00125-014-3460-0. Epub 2015 Jan 13. Diabetologia. 2015. PMID: 25583541 No abstract available.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical