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The Feasibility of Intensive Insulin Management in Non-Insulin-dependent Diabetes Mellitus: Implications of the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM

John A. Colwell, MD, PhD
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From the Department of Veterans Affairs Cooperative Studies Program, Hines, Illinois. For the current author address, see end of text. Note: This article is one of a series of articles comprising an Annals of Internal Medicine supplement entitled “Risks and Benefits of Intensive Management in Non-Insulin-dependent Diabetes Mellitus: The Fifth Regenstrief Conference.” To view a complete list of the articles included in this supplement, please view its Table of Contents. Acknowledgments: The authors thank Carlos Abraira, MD, for his leadership and the VACSDM investigators and staff for their able assistance. Grant Support: By the Department of Veterans Affairs Cooperative Studies Program. Requests for Reprints: John A. Colwell, MD, PhD, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29425.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1996;124(1_Part_2):131-135. doi:10.7326/0003-4819-124-1_Part_2-199601011-00010
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Objective: To review the results from the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM (VACSDM) and to discuss the implications of the results from this feasibility trial.

Design: A randomized clinical trial comprising 153 men with non–insulin-dependent diabetes mellitus (NIDDM) who remained hyperglycemic on usual pharmacologic therapy. Patients were randomized into two groups receiving either standard or intensive insulin therapy and were followed for 27 months.

Setting: Five Veterans Affairs medical centers.

Patients: 153 men with NIDDM, aged 40 to 69 years, who had hemoglobin A1c (HbA1c) levels of greater than 6.55% while receiving sulfonylurea or insulin therapy.

Intervention: Standard insulin therapy was one or two insulin injections daily. Intensive insulin therapy was done using a stepwise approach: 1) evening intermediate or long-acting insulin; 2) addition of daytime glipizide; 3) insulin twice daily, with no glipizide; and 4) insulin three to four times daily, with no glipizide.

Measurements: Fasting blood glucose and HbA1c levels, retinopathy, lipid and urinary albumin levels, cardiovascular events, hypoglycemia, and body mass index.

Results: In the intensive group, the HbA1c level fell 2.07 percentage points; the mean HbA1c level was 7.3% from 6 months onward. The standard group experienced little change. These changes occurred without significant weight gain and with a very low rate of severe hypoglycemia. Sixteen patients (20.5%) in the standard group and 24 patients (32%) in the intensive group had cardiovascular events (P = 0.1).

Conclusions: It is feasible to achieve excellent glycemic control in men with NIDDM in whom standard pharmacologic therapy has failed. The benefit/risk ratio of intensive insulin management in this patient group is not established and has been made the subject of a long-term prospective clinical trial.





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