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Complex Insulin Regimens & Type 2 Diabetes

In patients with refractory type 2 diabetes, the addition of certain insulin regimens seems to offer better control and fewer complications, reports the New England Journal of Medicine.

In a trial supported and partly managed by an insulin manufacturer, researchers followed some 700 patients who did not achieve glycemic control on metformin and a sulfonylurea. Patients were randomized to one of three regimens of added insulin:

  • twice-daily biphasic insulin aspart;
  • thrice-daily prandial aspart; or
  • once-daily (twice if necessary) basal insulin detemir.


If glycated hemoglobin was still above targets after the first year, the sulfonylurea was replaced with a second insulin:

  • midday prandial was added to the biphasic regimen;
  • bedtime basal was added to prandial; and
  • prandial was added to basal.

After 3 years, median glycated hemoglobin values (the primary endpoint) were essentially identical among groups. However, the biphasic group was least likely to have achieved a 6.5% hemoglobin level; the biphasic and prandial groups gained more weight than the basal group; and overall rates of hypoglycemia were highest in the prandial group.

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Source Information

From the Diabetes Trials Unit (R.R.H., J.L.D., J.F.K., S.K.P.), Oxford Centre for Diabetes, Endocrinology and Metabolism (R.R.H., A.J.F., J.C.L., J.L.D., J.F.K., S.K.P.), and the Department of Primary Health Care and National Institute for Health Research School of Primary Care Research (A.J.F.), University of Oxford, Oxford; and the Department of Cardiovascular Sciences, University of Leicester, Leicester (M.J.D.) — both in the United Kingdom.

Authors: - Rury R. Holman, M.B., Ch.B., F.R.C.P., Andrew J. Farmer, D.M., F.R.C.G.P., Melanie J. Davies, M.D., F.R.C.P., Jonathan C. Levy, M.D., F.R.C.P., Julie L. Darbyshire, M.A., M.Sc., Joanne F. Keenan, B.A., Sanjoy K. Paul, Ph.D., and the 4-T Study Group

This article (10.1056/NEJMoa0905479) was published on October 22, 2009, at

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