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Insulin degludec reduced risk for nocturnal hypoglycemia in patients requiring high doses of insulin

Patients with type 1 diabetes who were administered high doses of once-daily insulin degludec demonstrated lower nocturnal hypoglycemia compared with patients administered similar doses of insulin glargine.

Insulin degludec is a next-generation basal insulin which has an ultra-long stable action profile with low hour-to-hour and day-to-day variability. A key finding in insulin degludec phase 3a clinical trials has been a consistent reduction in hypoglycemia risk compared to insulin glargine,” Helena W. Rodbard, MD, FACP, MACE, medical director of Endocrine and Metabolic Consultants in Rockville, Md., and past-president of AACE, said during a presentation here at the AACE Annual Scientific and Clinical Congress. Approximately 25% of patients in the study (235 of 950) received an end-of-trial basal insulin dose of greater than 0.45 U/kg and were included in the meta-analysis.

Confirmed overall hypoglycemia rates (FPG <56 mg/dL or severe hypoglycemia) were similar for both groups for the full duration of the trial and for the maintenance period after 16 weeks into the trial.

However, subjects receiving insulin degludec experienced a significantly lower rate of nocturnal confirmed hypoglycemia (12 a.m. to 6 a.m.) with a 36% reduction in the rate for the full study duration (relative rate=0.64; 95% CI, 0.42-0.99). The rate of nocturnal hypoglycemia was reduced by 44% during the maintenance period (relative rate=0.56; 95% CI, 0.33-0.95).

“These findings are consistent with results for the overall study population, confirming that insulin degludec is a well-tolerated and effective basal insulin choice for patients with type 1 diabetes across the spectrum of insulin requirements,” Rodbard said.

Rodbard reported that the mean end-of-trial basal insulin dose was similar for insulin degludec (0.63 U/kg) and insulin glargine (0.65 U/kg). Patients displayed similar mean HbA1c levels with insulin degludec and insulin glargine (7.41% vs. 7.55%). The difference between insulin degludec and insulin glargine was only less than 0.1 percentagepoints and was not statistically significant. Similarly, the fasting plasma glucose (FPG) levels at the end of the trial were comparable (133mg/dL vs. 136 mg/dL) and the difference between the two types of insulin was not statistically significant. Thus, insulin degludec has the same efficacy as insulin glargine in terms of effectiveness on HbA1c and FPG in this treat-to-target experimental paradigm, but it has significantly lower risk of nocturnal hypoglycemia in this special group of patients requiring higher than average daily doses of insulin.
Source: Rodbard H. Abstract #279. AACE Annual Scientific and Clinical Congress; 2013; Phoenix
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