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Inhaled Insulin AFRESA(R) Controls Post-Meal Sugar Levels with Less Weight Gain and Hypoglycemia

Posted: Wednesday, June 17, 2009

The findings of two 52-week studies show that the investigational ultra rapid acting insulin AFRESA® (insulin human [rDNA origin]) Inhalation Powder combined with basal insulin is comparable to standard of care therapies in controlling post-meal blood sugar levels, and also results in significantly less weight gain and risk of hypoglycemia for adult patients with diabetes.

AFRESA is a novel, ultra rapid acting mealtime insulin therapy with an action profile that mimics meal-related early insulin release. Based on an extensive phase 3 clinical program, a New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) requesting approval to market AFRESA Inhalation Powder and the AFRESA Inhaler for use in adult patients with Type 1 and Type 2 diabetes mellitus for the treatment of hyperglycemia. AFRESA is conveniently administered by oral inhalation.

Included in the study were patients with Type 2 diabetes who were inadequately controlled (A1c >7.0% and </=11.0%) despite insulin with or without oral anti-hyperglycemic therapy, randomized to a 52-week course of either AFRESA (TI) and bedtime glargine insulin (G) (n=334) or premixed biaspart 70/30 insulin BID (BPA 70/30) twice-a-day (n=343). The primary endpoint was mean change from baseline to week 52 in A1c. Secondary objectives were proportion of subjects reaching specific A1c levels and treatment differences in postprandial plasma glucose (PPG), fasting plasma glucose (FPG), and weight.

A1c was reduced by -0.66% and -0.72% in the TI+G and BPA 70/30 groups, respectively, and the proportion of subjects achieving A1c <7.0% were comparable between treatments (22% vs 27%). One-hour PPG change from baseline after a meal challenge was significantly lower in the TI+G group (37 vs. 54 mg/dL; p<0.0001). TI+G produced significantly less weight gain (0.9 vs. 2.5 kg; p=0.0002) and significantly less mild/moderate (48 percent vs. 69 percent, p<0.001) and severe (4 percent vs. 10 percent, p=0.0066) hypoglycemia compared to the BPA 70/30 group. Mean changes from baseline to week 52 in pulmonary function tests were similar in the two groups.

In the second study, patients with Type 1 diabetes (A1c >7.0% and </=11.0%) were randomized to a 52-week trial comparing AFRESA (n=301) with insulin aspart, a rapid acting analog (RAA) (n=288), both given at meals with insulin glargine, a long-acting analog (LAA). Pre-specified efficacy endpoints included change in A1c, 1-hour PPG, 2-hour PPG and FPG following a standard meal challenge, and body weight. Adverse events were monitored to compare safety profiles.

Reductions in A1c were comparable in both treatment groups with no significant differences in LAA doses in either group. FPG levels (-35.5 +/- 3.3 vs. -20.6 +/- 3.2, p=0.0012) and 1-hour PPG (20.9 +/- 4.79 vs. 40.5 +/- 4.56, CI=0.0022) values were significantly lower with AFRESA than with RAA. Patients in the AFRESA group lost weight (-0.5 +/- 0.3), while patients in the RAA group gained weight (+1.4 +/- 0.3), with the difference being statistically significant (p<0.0001). Finally, the AFRESA group had a statistically significant reduction in the incidence of mild/moderate (odds ratio [OR] 0.474, confidence interval [CI] 0.271, 0.831; p=0.0091) and total hypoglycemia (OR 0.488; CI 0.278, 0.856; p=0.0124).

Source: Diabetes In Control: Presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.