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.

  • Image Result

    Number of subjects within incremental HbA1c ranges at baseline and endpoint. Numbers above bars indicate numbers of patients within each HbA1c range.

    Number of subjects within incremental HbA1c ranges at baseline and endpoint. Numbers above bars indicate numbers of patients within each HbA1c range.

  • Image Result

    Similar decreases in HbA1c over time were observed for all treatment groups. Number of subjects at each timepoint: Baseline: 1409, 1415, 1370; Week 12: 1405, 1413, 1365; Week 24: 1285, 1297, 1252; for

    Similar decreases in HbA1c over time were observed for all treatment groups. Number of subjects at each timepoint: Baseline: 1409, 1415, 1370; Week 12: 1405, 1413, 1365; Week 24: 1285, 1297, 1252; for NC, 1C, and 3C, respectively.

  • Image Result
    Eight-point self-measured blood glucose readings. Measurements were taken 30 minutes before breakfast, lunch, and dinner (BB, BL, and BD); 2 hours after breakfast, lunch, and dinner (AB, AL, and AD);

    Eight-point self-measured blood glucose readings. Measurements were taken 30 minutes before breakfast, lunch, and dinner (BB, BL, and BD); 2 hours after breakfast, lunch, and dinner (AB, AL, and AD); at bedtime (Bed); and at 3:00 a.m. Number of data points at each timepoint at baseline: 1141 to 1364; at the end of the study, last observation carried forward: 1155 to 1352 (upper limit is for before breakfast, lower limit for 3:00 AM, for both baseline and last observation carried forward).

 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

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