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Insulin Glargine Shows Glycemic Control With Less Nocturnal Hypoglycemia : Presented at ADA

By Bruce Sylvester
Special to DG News

SAN FRANCISCO, CA -- June 18, 2002 -- Addition of basal insulin to oral anti-diabetic agents can restore the majority of Type 2 diabetic patients to an optimal HbA1c level with insulin glargine (Lantus) rather than NPH insulin, causing fewer nocturnal hypoglycemic events, researchers reported at the annual meeting of the American Diabetes Association (ADA).

"There were two research questions," said Matthew Riddle, MD, professor of endocrinology, Oregon Health and Sciences University in Portland, United States. "First, how much success with HbA1c levels can be had with basal insulin replacement aggressively done with patients who fail oral agents with Type 2 diabetes. Second, does it make a difference which kind of long-acting insulin is used, that is, is glargine equal to, better than or not as good as NPH, which we've always used?

"The results showed that, with aggressive titration, very good HbA1c levels can be reached both ways. However, the other major finding is that if the glargine is used instead of the NPH, there is a great deal less hypoglycemia. Starting insulin late has been one of the big problems in the management of Type-2 diabetes. Doctors and patients are afraid of insulin and reluctant to start on it. The main fear is of hypoglycemia. If glargine really does cause less hypoglycemia, then using it may look more attractive to many doctors in primary care and their patients as well," Dr. Riddle added.

This 24-week, multicenter, randomized, parallel, open-label trial compared the efficacy of bedtime administration of insulin glargine to NPH insulin. The investigators enrolled 756 insulin-naïve patients, with 367 intent to treat (ITT) subjects assigned insulin glargine and 389 subjects assigned NPH insulin. Each subject had indicated inadequate glycemic control when using one or two oral agents.

Duration of diabetes was eight to nine years, and baseline HbA1c was 8.6 percent. Mean age was 55 years, mean body mass index was 32 kg/m².

The investigators' principal aim was to determine the ability of each patient group to reach HbA1c less than or equal to 7.0 percent without clinically significant nocturnal hypoglycemia. They also measured for fasting plasma glucose (FPG), HbA1c, and hypoglycemia, and adjusted the dosage of insulin weekly by a forced-titration schedule aiming for FPG less than or equal to 100 mg/dL (5.6 mM), unless prevented from doing so by hypoglycemia.

ITT analysis indicated that insulin glargine and NPH insulin achieved good glycemic control. Mean FPG declined to 117 (6.50mM) in the insulin glargine group and to 120 mg/dL (6.68 mM) in the NPH insulin group. Mean HbA1c fell to 6.96 percent in the insulin glargine group and 6.97 percent in the NPH insulin group.

Fifty-seven percent of the subjects reached the goal of HbA1c less than 7 percent by the end of the study. Significantly more of the insulin glargine subjects reached HbA1c less than or equal to 7.0 percent without documented nocturnal hypoglycemia of less than 72 mg/dL (33 percent insulin glargine vs 27 percent NPH insulin).

Treatment with insulin glargine caused less nocturnal hypoglycemia documented at less than 72 mg/dL than NPH insulin (532 vs 886 events in 40 vs 49 percent of subjects). The rate of severe hypoglycemia (requiring assistance) was low in both groups (2.5 and 2.3 percent of subjects).

"The optimal efficacy of this method and relative improvement rates of various insulins remains to be studied," the researchers reported.

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