Additional Analyses Showed Pramlintide Improved Treatment Satisfaction and Quality of Life
NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced data showing that the use of mealtime SYMLIN(R) (pramlintide acetate) injection improved glucose control, treatment satisfaction and quality of life for patients with type 2 diabetes. These findings were detailed in oral and poster presentations at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.
This 36-week, randomized, open-label study was designed to compare the efficacy and safety of mealtime pramlintide, rapid-acting insulin or both agents in patients with type 2 diabetes using basal insulin therapy. The multicenter study included 112 patients with type 2 diabetes with an average age of 54 years, baseline A1C of 8.2 percent, fasting plasma glucose of 160 mg/dL and body mass index (BMI) of 36 kg/m2.
Phase 1 of the study (24 weeks) compared mealtime SYMLIN 120 micrograms three times daily with mealtime rapid-acting insulin, when either agent was added to basal insulin. At the end of Phase 1 (week 24), 30 percent of patients treated with SYMLIN achieved the composite primary endpoint (A1C =7.0 percent, no weight gain and no severe hypoglycemia), compared with 11 percent of rapid-acting insulin patients. An A1C of 7 percent or less is the ADA goal for glycemic control for diabetic patients. SYMLIN recipients had a lower incidence of hypoglycemia (55 percent vs. 82 percent). Use of SYMLIN or rapid-acting insulin resulted in similar A1C reductions (-1.1 percent vs. -1.3 percent) and fasting plasma glucose concentrations (122 vs. 123 mg/dL) at week 24; however, significant weight gain from baseline was only seen with rapid-acting insulin treatment (+4.7 kg, P<0.001 vs. baseline). Use of SYMLIN was not associated with weight gain.
'The effect of SYMLIN was similar to that of mealtime rapid-acting insulin when added to basal insulin treatment in this study, with SYMLIN use resulting in no weight gain and less hypoglycemia,' said Dennis Karounos, staff physician and associate professor of internal medicine, Lexington Veterans Affairs Medical Center and University of Kentucky College of Medicine. 'For patients recently requiring basal insulin, adding mealtime therapy with pramlintide may be a preferable alternative to mealtime rapid-acting insulin.'
Phase 2 of the study (12 weeks) explored additional mealtime therapy for patients failing to achieve a target A1C of 6.5 percent or less at week 24. SYMLIN recipients not achieving target A1C (n=31) added rapid-acting insulin at week 26, while rapid-acting insulin recipients not achieving target A1C (n=36) added SYMLIN at week 26. For both combination groups, A1C and weight remained relatively stable throughout Phase 2. The addition of SYMLIN in Phase 2 for patients initially receiving rapid-acting insulin allowed a marked reduction in the amount of rapid-acting insulin used (38.6 plus or minus 3.8 U/d at week 24 vs. 19.4 plus or minus 3.2 U/d at week 36).
Patients who achieved an A1C of 6.5 percent or less at week 24 did not add an additional agent in the second phase of the study. For those patients, A1C levels were stable in both groups and no significant weight change occurred.
