Dr. Garber and colleagues conducted a pooled analysis of 3 phase 3 trials to compare the benefits and risks of insulin detemir against those of NPH insulin in subjects with type 2 diabetes.

"Tight glycemic control in diabetes has been shown to lead to fewer late diabetic complications," Dr. Garber noted. "Low hemoglobin A1c [HbA1c] is difficult to obtain due to hypoglycemia, especially in elderly people who are more vulnerable to hypoglycemia and its sequelae due to reduced insulin clearance and associated comorbidities."

Insulin detemir is a basal insulin analog shown to have an effect on HbA1c that is similar to that of NPH insulin but with lower variability in levels of fasting plasma glucose, lower risk of hypoglycemia, and lower weight gain than are generally seen with NPH insulin, he continued.

The present analysis included 418 elderly (65 years or more) and 90 young (< 65 years) subjects with type 2 diabetes who were treated with basal plus mealtime insulin or oral agents for 24 to 26 weeks.

Baseline characteristics were similar in elderly and young people except for age and duration of diabetes.

Results showed that HbA1c levels were similar with insulin detemir and NPH insulin for both elderly (7.2 mmol for elderly on either medication) and young patients (7.3 mmol with insulin detemir vs 7.2 mmol with NPH).

Fasting plasma glucose levels were similar in the insulin detemir and NPH arms for both elderly (8.0 mmol for both drugs) and young patients (8.2 mmol with insulin detemir and 8.0 mmol with NPH).

The insulin detemir arm of the study gained less body weight than did the NPH arm both among elderly (0.6 kg vs 1.6 kg, respectively) and young patients (0.8 kg vs 2.0 kg, respectively).

Within-person variations in fasting blood glucose were lower with insulin detemir than with NPH insulin for both elderly and young subjects.

Risk of hypoglycemia was 40% lower with insulin detemir than with NPH insulin (Risk Ratio (RR) =.60, P =.003). For the young, the risk of hypoglycemia was 23% lower with insulin detemir than with NPH insulin (RR =.77, P =.038).

The incidence and pattern of adverse events were similar between treatments and between age groups.

"The benefits of insulin detemir -- less hypoglycemia, less within-person fasting plasma glucose variation, and less weight gain -- compared to NPH insulin was seen in elderly as well as in young people with type 2 diabetes without an increase in risk," Dr. Garber noted.

The study was sponsored by Novo Nordisk A/S n Bagsvaerd, Denmark, maker of Levemir.


[Presentation title: Lower Risk of Hypoglycemia With Insulin Detemir Vs. NPH Insulin in Elderly People With Type 2 Diabetes. Abstract 479-P]

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