In clinical trials, adding SYMLIN to insulin provided adults with type 2 diabetes not adequately controlled on mealtime insulin with reductions in A1C at 6 months. The administration of SYMLIN in addition to insulin also resulted in reduced body weight and was associated with changes in mealtime insulin dose requirements.

SYMLIN is not indicated for weight loss. Change in body weight was a secondary endpoint.

When initiating SYMLIN, reduce mealtime insulin dose (including premixed insulins) by 50% to reduce the risk of hypoglycemia. Monitor glucose frequently and individualize subsequent insulin dose adjustments.

 

Study Design

Two (26-week1 and 52-week2) phase 3, double-blind, randomized, placebo-controlled, parallel-group multicenter trials evaluated the efficacy and safety of pramlintide plus insulin compared to insulin alone in patients with type 2 diabetes and inadequate glycemic control. Patients’ background oral antihyperglycemic medications (metformin/sulfonylurea) remained stable during the course of both studies. 

 

SYMLIN + Insulin Reduced A1C

In 2 placebo-controlled trials, adding SYMLIN to mealtime insulin provided A1C reductions at 6 months in adults with type 2 diabetes, when insulin dosing adjustments were limited.1-3,*

Mean change in A1C (primary endpoint) compared to placebo + insulin

Mean change in A1C (primary endpoint) compared to placebo + insulin Mean change in A1C (primary endpoint) compared to placebo + insulin Mean change in A1C (primary endpoint) compared to placebo + insulin Mean change in A1C (primary endpoint) compared to placebo + insulin

*Insulin dosing adjustments were allowed at investigator’s discretion in cases of excessive hypoglycemia.

 

SYMLIN + Insulin Reduced Body Weight

Adding SYMLIN to mealtime insulin reduced body weight at 6 months in 2 placebo-controlled trials in adults with type 2 diabetes, when insulin dosing adjustments were limited.1-3,*

Mean change in body weight compared to placebo + insulin

Mean change in body weight compared to placebo + insulin Mean change in body compared to placebo + insulin Mean change in body compared to placebo + insulin Mean change in body compared to placebo + insulin

SYMLIN is not indicated for weight loss. Change in body weight was a secondary endpoint.

*Insulin dosing adjustments were allowed at investigator’s discretion in cases of excessive hypoglycemia.

 

SYMLIN + Insulin: Change in Mealtime Insulin Dose

In clinical trials in adults with type 2 diabetes when SYMLIN was added to insulin, changes in mealtime insulin dose requirements were observed at 6 months. In these trials, insulin dosing adjustments were limited.1-3*

Mean change in mealtime/bolus insulin doses compared to placebo + insulin

Mean change in mealtime/bolus insulin doses compared to placebo + insulin Mean change in mealtime/bolus insulin doses compared to placebo + insulin Mean change in mealtime/bolus insulin doses compared to placebo + insulin Mean change in mealtime/bolus insulin doses compared to placebo + insulin

Change in mealtime insulin dose was a secondary endpoint.

*Insulin dosing adjustments were allowed at investigator’s discretion in cases of excessive hypoglycemia.

When initiating SYMLIN, reduce mealtime insulin dose (including premixed insulins) by 50% to reduce the risk of hypoglycemia. Monitor glucose frequently and individualize subsequent insulin dose adjustments.