“Three-Year Efficacy of Complex Insulin Regimens in Type 2 Diabetes”

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NTDP Cohort 7 Journal Critique Title: “Three-Year Efficacy of Complex Insulin Regimens in Type 2 Diabetes” Journal: The New England Journal of Medicine, vol. 361, no. 18, pages 1736-1747 Purpose: How do complex insulin regimens affect glycated hemoglobin, rate of hypoglycemia and weight gain in type 2 diabetic patients? Introduction Type 2 diabetes mellitus is often treated with metformin and an oral hypoglycemic agent (e.g. sulfonylurea); however, if this combination is not effective, insulin is often added to replace the oral hypoglycemic agent for better blood sugar control. In type 1 diabetes, intensive insulin therapy is designed to mimic normal insulin secretion as closely as possible.1 While the benefits of the combination of basal (long-acting) and prandial (bolus or fast-acting) insulin have been proven in type 1 diabetics, the best possible insulin regimen to be used in type 2 diabetics has not been established. By evaluating patients with type 2 diabetes with suboptimal glycemic control, the first phase of the Treating to Target in Type 2 Diabetes (4-T) study was designed to compare the clinical effects of adding biphasic, prandial, or basal analogue insulin. If glycated hemoglobin levels (HbA1C) were greater than 6.5% with a single type of insulin, the sulfonylurea therapy was replaced by a second type of insulin (complex regimen). Study Description The first phase of the 4-T study was an open-label, multicenter, randomized three year trial including 708 patients who had suboptimal HbA1C levels (7-10%) while taking metformin and sulfonylurea therapy for at least 4 months. The study included men and women 18 years or older (mean age was 61.7 years), with a body-mass index of 40... ... middle of paper ... ...mpared to prandial insulin, to a patient’s current therapy of oral agents. Works Cited 1) Koda-Kimble, MA, Young, LY, Kradjan, WA, Guglielmo, BJ, Alldredge, BK, Corelli, RL, editors. Applied Therapeutics: the clinical use of drugs. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. 2) Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G SO. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. Epub 2008 Jan 16. 3) AACE/ADA Consensus Statement Consensus: Inpatient Hyperglycemia, Endocrine Practice 2009;15(No. 4) 13:1-17. 4) Cryer, PE. Hypoglycemia in diabetes. Pathophysiology, prevalence, and prevention. American Diabetes Asociation, Alexandria VA, 2009.

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