In clinical trials, adding SYMLIN to insulin provided adults with type 1 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 Designs

Three (one 26-week,1 two 52-week2,3) phase 3, double-blind, randomized, placebo-controlled, parallel-group, multicenter, pivotal trials evaluated the efficacy and safety of pramlintide plus insulin compared to insulin alone in patients with type 1 diabetes mellitus and inadequate glycemic control.

A 6-month, phase 3, double-blind, randomized, placebo-controlled dose-titration trial evaluated the efficacy and safety of pramlintide plus insulin compared to insulin alone in patients with type 1 diabetes mellitus.

 

SYMLIN + Insulin Reduced A1C

Adding SYMLIN to mealtime insulin provided A1C reductions at 6 months in adults with type 1 diabetes in 3 placebo-controlled trials, when insulin dosing adjustments were limited.1-4,*

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.

In a placebo-controlled dose-titration trial in adults with type 1 diabetes, adding SYMLIN to mealtime insulin produced similar A1C reductions at 6 months.4

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
 

SYMLIN + Insulin Reduced Body Weight

When added to mealtime insulin, SYMLIN reduced body weight at 6 months in 3 placebo-controlled trials in adults with type 1 diabetes, when insulin dosing adjustments were limited.1-4,*

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 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.

In a placebo-controlled dose-titration trial in adults with type 1 diabetes, adding SYMLIN to mealtime insulin reduced body weight at 6 months.4

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 Mean change in body compared to placebo + insulin

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

 

SYMLIN + Insulin: Change in Mealtime Insulin Dose

In clinical trials in adults with type 1 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.1,3,4,*

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

Mean change in mealtime/bolus insulin dose was not measured in Trial 1

Mean change in mealtime/bolus insulin dose compared to placebo + insulin Mean change in mealtime/bolus insulin dose compared to placebo + insulin Mean change in mealtime/bolus insulin dose compared to placebo + insulin Mean change in mealtime/bolus insulin dose 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.

In a placebo-controlled dose-titration trial in adults with type 1 diabetes, changes in mealtime insulin dose requirements were observed at 6 months when SYMLIN was added to insulin.4

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

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

Change in mealtime insulin dose 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.