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.

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.