The American Journal of Medicine
Volume 122, Issue 11 , Pages 1043-1049 , November 2009

A1c Control in a Primary Care Setting: Self-titrating an Insulin Analog Pre-mix (INITIATEplus Trial)

  • David S. Oyer, MD

      Affiliations

    • Feinberg School of Medicine, Northwestern University, Chicago, Ill
    • Corresponding Author InformationRequests for reprints should be addressed to David S. Oyer, MD, 211 East Chicago Avenue, Chicago, IL 60611
    • ,
  • Mark D. Shepherd, MD

      Affiliations

    • Endocrinology Consultants, Tupelo, Miss
    • ,
  • Franklin C. Coulter, MD

      Affiliations

    • Coulter Clinic, Orangeburg, SC
    • ,
  • Anuj Bhargava, MD

      Affiliations

    • Iowa Diabetes and Endocrinology Center, Des Moines, IA
    • ,
  • Jason Brett, MD

      Affiliations

    • Novo Nordisk Inc., Princeton, NJ
    • ,
  • Pei-Ling Chu, PhD

      Affiliations

    • Novo Nordisk Inc., Princeton, NJ
    • ,
  • Bruce S. Trippe, MD

      Affiliations

    • Endocrinology Associates, Montgomery, Ala
    • ,
  • The INITIATEplus Study Group

      Affiliations

    • The members of the INITIATEplus Study Group are listed online.

References 

  1. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047–1053
  2. Pinhas-Hamiel O, Zeitler P. The global spread of type 2 diabetes mellitus in children and adolescents. J Pediatr. 2005;146:693–700
  3. Ford ES, Li C, Little RR, Mokdad AH. Trends in A1C concentrations among U.S. adults with diagnosed diabetes from 1999 to 2004. Diabetes Care. 2008;31:102–104
  4. Hoerger TJ, Segel JE, Gregg EW, Saaddine JB. Is glycemic control improving in U.S. adults?. Diabetes Care. 2008;31:81–86
  5. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2009;32(Suppl 1):S13–S61
  6. Rodbard HW, Blonde L, Braithwaite SS, et al. American Association of Clinical Endocrinologists Medical Guidelines for the Management of Diabetes Mellitus. Endocr Pract. 2007;13(Suppl 1):1–68
  7. 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(9131):837–853
  8. Polonsky WH, Fisher L, Guzman S, et al. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care. 2005;28:2543–2545
  9. Nichols GA, Alexander CM, Girman CJ, et al. Treatment escalation and rise in HbA1c following successful initial metformin therapy. Diabetes Care. 2006;29:504–509
  10. Hirsch IB, Bergebstal RM, Parkin CG, et al. A real-world approach to insulin therapy in primary care practice. Clin Diabetes. 2005;23:78–86
  11. Riddle MC. The underuse of insulin therapy in North America. Diabetes Metab Res Rev. 2002;18:S42–S49
  12. Peyrot M, Rubin RR, Lauritzen T, et al. International DAWN Advisory Panel Resistance to insulin therapy among patients and providers, results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673–2679
  13. 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 (A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes). Diabetes Care. 2009;32:193–203
  14. Delahanty LM, Halford BN. The role of diet behaviors in achieving improved glycemic control in intensively treated patients in the Diabetes Control and Complications Trial. Diabetes Care. 1993;16(11):1453–1458
  15. World Medical Association Declaration of Helsinki. Recommendations guiding medical physicians in biomedical research involving human subjects. JAMA. 1997;277:925–926
  16. Holman RR, Thorne KI, Farmer AJ, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type2 diabetes. N Engl J Med. 2007;357:1716–1730
  17. Raskin P, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005;28:260–265
  18. Garber AJ, Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes Metab. 2006;8:58–66
  19. Brown JB, Nichols GA. Slow response to loss of glycemic control in type 2 diabetes mellitus. Am J Manag Care. 2003;9:213–217

 Funding: This clinical study was supported by Novo Nordisk Inc., Princeton, NJ.

 Conflict of Interest: The following disclosures address potential conflicts of interest by the authors for the manuscript: David S. Oyer is on the speaker bureau and advisory board for Novo Nordisk Inc., and on the speaker's bureaus for Amylin, Lilly, Merck, Sanofi-Aventis, and Novartis. Mark D. Shepherd is affiliated with the sponsoring organization, Novo Nordisk Inc. as a consultant, national speaker, researcher, recipient of grant support, and a shareholder in the company. Franklin C. Coulter is on the speaker bureau for Novo Nordisk Inc. for Novolog® Mix 70/30 and for Levemir®. He also is on the advisory board for Novolog® Mix 70/30. Anuj Bhargava is on the speaker's bureaus for Novo Nordisk Inc., Sanofi Aventis, Pfizer, Amylin Pharmaceuticals, Abbott Laboratories, Medtronic and Takeda Pharmaceuticals. He has been or is involved in research studies with Novo Nordisk Inc., Pfizer, Amylin Pharmaceuticals, Lilly, Sanofi Aventis and Merck. Jason Brett and Pei-Ling Chu are employees of Novo Nordisk Inc. Bruce S. Trippe has been on the speaker's bureaus for Astra Zenica, Glaxo Smith Kline, Novartis, Merck, Schering Plough, Sanofi Aventis, Novo Nordisk Inc., and Abbott; he has received grant support from Novo Nordisk Inc. for clinical research.

 Authorship: The work submitted in this manuscript is original and all authors meet the criteria for authorship, including access to the data, a role in performing the research, writing the manuscript, and acceptance of responsibility for the scientific content of the manuscript.

PII: S0002-9343(09)00667-6

doi: 10.1016/j.amjmed.2008.12.026

The American Journal of Medicine
Volume 122, Issue 11 , Pages 1043-1049 , November 2009

Article Tools

* Image Usage & Resolution