“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
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The rates of grade 2 or 3 hypoglycemia were low overall among the different groups; however, the prandial group experienced the most hypoglycemic episodes. Weight gain was more prominent in the biphasic and prandial groups, and the prandial group had the greatest reduction in the postprandial glucometer readings. While the percentage of patients in the biphasic group that replaced the sulfonylurea with a second type of insulin was 67.7%, the percentage in the prandial and basal group was 73.6% and 81.6%, respectively. The majority of patients from all three groups eventually required a basal-bolus (complex) regimen. The results of the trial support that the basal-bolus insulin regimen may be beneficial for better blood sugar control in type 2 diabetes.

Strengths and Weaknesses:
The first phase of the 4-T study had several strong points. The major strengths of this study were the randomized design and the long duration. The patients were recruited in 58 clinical centers, and to account for center-level clustering, the study center was included as a random effect in all regression models. There was equal distribution between the biphasic (235 patients), prandial (239 patients), and basal (234 patients) groups. There was not a statistical significant difference in the baseline variables of the patients between the three groups. The study had several weaknesses and limitations. It only included patients from the United
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