Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Therapy Are Equally Effective in Type 2 Diabetes

A randomized, parallel-group, 24-week study

  1. Philip Raskin, MD1,
  2. Bruce W. Bode, MD2,
  3. Jennifer B. Marks, MD3,
  4. Irl B. Hirsch, MD4,
  5. Richard L. Weinstein, MD5,
  6. Janet B. McGill, MD6,
  7. Gregory E. Peterson, DO7,
  8. Sunder R. Mudaliar, MD8 and
  9. Rickey R. Reinhardt, MD, PHD9
  1. 1University of Texas, Southwestern Medical Center, Dallas, Texas
  2. 2Atlanta Diabetes Associates, Atlanta, Georgia
  3. 3University of Miami, Miami, Florida
  4. 4University of Washington, Seattle, Washington
  5. 5Diablo Clinical Research, Walnut Creek, Californnia
  6. 6Washington University, St. Louis, Missouri
  7. 7Diagnostic and Critical Care Medicine, Des Moines, Iowa
  8. 8VA Medical Center, San Diego, California
  9. 9Novo Nordisk Pharmaceuticals, Princeton, New Jersey
  1. Address correspondence and reprint requests to Philip Raskin, MD, University of Texas, Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-8858. E-mail: praski{at}mednet.swmed.edu

Abstract

OBJECTIVE—Compare the efficacy, safety, and patient satisfaction of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy for patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS—A total of 132 CSII-naive type 2 diabetic patients were randomly assigned (1:1) to CSII (using insulin aspart) or MDI therapy (bolus insulin aspart and basal NPH insulin) in a multicenter, open-label, randomized, parallel-group, 24-week study. Efficacy was assessed with HbA1c and eight-point blood glucose (BG) profiles. Treatment satisfaction was determined with a self-administered questionnaire. Safety assessments included adverse events, hypoglycemic episodes, laboratory values, and physical examination findings.

RESULTS—HbA1c values decreased similarly for both groups from baseline (8.2 ± 1.37% for CSII, 8.0 ± 1.08% for MDI) to end of study (7.6 ± 1.22% for CSII, 7.5 ± 1.22% for MDI). The CSII group showed a trend toward lower eight-point BG values at most time points (only significant 90 min after breakfast; 167 ± 48 vs. 192 ± 65 mg/dl for CSII and MDI, respectively; P = 0.019). A total of 93% of CSII-treated subjects preferred the pump to their previous injectable insulin regimen for reasons of convenience, flexibility, ease of use, and overall preference. Safety assessments were comparable for both treatment groups.

CONCLUSIONS—Insulin aspart in CSII therapy provided efficacy and safety comparable to MDI therapy for type 2 diabetes. Patients with type 2 diabetes can be trained as outpatients to use CSII and prefer CSII to injections, indicating that pump therapy should be considered when initiating intensive insulin therapy for type 2 diabetes.

Footnotes

  • P.R. is a consultant to, receives grant and research support from, and serves on the Medical Advisory Board of Novo Nordisk Pharmaceuticals. B.W.B. serves on the Medical Advisory Board of Medtronic/MiniMed and Novo Nordisk Pharmaceuticals; receives honoraria from Medtronic/MiniMed, Novo Nordisk, Eli Lilly, and Aventis; and receives grant and research support from Novo Nordisk, Aventis, and Eli Lilly. J.B.M. receives grant/research support from Eli Lilly, Takeda Pharmaceuticals, Aventis Pharmaceuticals, Novo Nordisk, Smith Kline Beecham, Neurocrine Biosciences, Bristol Myers Squibb, Nobex, Pfizer, Institute for Diabetes Discovery, Biostratum, EMD Pharmaceuticals, and Medtronic/MiniMed; serves as a consultant to and on the Advisory Board of Bristol Myers Squibb, Aventis Pharmaceuticals, Novo Nordisk, and Roche Pharmaceuticals; and receives honoraria from Bristol Myers Squibb, Aventis Pharmaceuticals, Novo Nordisk, and Roche Pharmaceuticals. I.B.H. is a consultant for Novo Nordisk, Eli Lilly, and Medtronic/MiniMed and receives research support from Novo Nordisk. R.L.W. is President and Medical Director of Diablo Clinical Research. J.B.M. received honoraria for speaking engagements from Novo Nordisk and her institution, Washington University, and has received funds to support the conduct of the clinical research project discussed herein as well as other clinical trials. G.E.P. is a stockholder of Novo Nordisk. S.R.M. has received grant support from Novo Nordisk to conduct research on treatments for diabetes.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    • Accepted June 16, 2003.
    • Received November 25, 2002.
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  1. doi: 10.2337/diacare.26.9.2598 Diabetes Care September 2003 vol. 26 no. 9 2598-2603
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