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news.Symlin (pramlintide acetate) injection showed improvement in glucose control for patients with type 2 diabetes.
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Amylin has announced that the use of mealtime Symlin (pramlintide acetate) injection has improved glucose control, treatment satisfaction and quality of life for patients with type 2 diabetes.
The 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 study included 112 patients with type 2 diabetes with an average age of 54 years, baseline A1C of 8.2%, fasting plasma glucose of 160 mg/dL, and body mass index (BMI) of 36 kg/m2.
Phase 1 of the study 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, 30% of patients treated with Symlin achieved the composite primary endpoint compared with 11% of rapid-acting insulin patients.
Symlin recipients had a lower incidence of hypoglycemia. Use of Symlin or rapid-acting insulin resulted in similar A1C reductions (-1.1 percent vs. -1.3 percent) and fasting plasma glucose concentrations.
However, a significant weight gain from baseline was only seen with rapid-acting insulin treatment .
Phase-II of the study explored additional mealtime therapy for patients failing to achieve a target A1C of 6.5% in phase 1. Patients who achieved an A1C of 6.5% or less 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.
Dennis Karounos, Staff Physician and Associate Professor of internal medicine, said: 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.
For patients recently requiring basal insulin, adding mealtime therapy with pramlintide may be a preferable alternative to mealtime rapid-acting insulin, he added.