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Clinical Diabetes 26:63-64, 2008
DOI: 10.2337/diaclin.26.2.63
© 2008 by the American Diabetes Association
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Landmark Study

Choosing an Insulin Regimen for Patients With Type 2 Diabetes

Michael Pignone, MD, MPH

The first 20% of the full text of this article appears below.


   STUDY
 
Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group: Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med357 : 1716-1730,2007[Abstract/Free Full Text]


   SUMMARY
 
Design. A randomized controlled trial comparing three insulin regimens: biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (with the option of twice daily if needed).

Subjects. Participants included 708 patients (64% male) ≥ 18 years of age (mean age 61.7 years) with type 2 diabetes, hemoglobin A1c (A1C) levels of 7.0-10.0% on maximally tolerated doses of sulfonylurea and metformin, who were willing to inject insulin and perform self-monitoring of blood glucose. Patients with BMI > 40 kg/m2, taking thiazolidinediones, or who had been diagnosed with retinopathy or nephropathy were excluded.

Methods. Participants were recruited from 58 clinical centers in the United Kingdom and Ireland and randomized centrally. Participants assigned to each group were managed according to a regimen-specific trial algorithm that estimated starting insulin dose. Patients were then seen at 2, 6, 12, 24, 38, and 52 weeks . . . [Full Text of this Article]


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