SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within 3 hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk.
(pramlintide acetate) Injection
SYMLIN® (pramlintide acetate) Injection is an antihyperglycemic drug for use in patients with diabetes treated with insulin. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at positions 25 (alanine), 28 (serine), and 29 (serine).
SYMLIN is given at mealtimes and is indicated for:
- Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
- Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin.
Published Studies Related to Symlin (Pramlintide Subcutaneous)
Efficacy and harms of the hypoglycemic agent pramlintide in diabetes mellitus. [2010.11]
PURPOSE: We conducted a study to examine the efficacy, effectiveness, and harms of pramlintide as adjunct therapy in adults and children with type 1 or type 2 diabetes... CONCLUSIONS: Pramlintide was somewhat more effective than placebo as adjunct therapy for improving HbA(1c) levels and weight in adults with type 1 diabetes on conventional insulin therapy, or type 2 diabetes and inadequate glycemic control with their current therapies, with between-group differences in HbA(1c) levels in the range of 0.2% to 0.4%. Further research is needed to determine pramlintide's durability of hypoglycemic effect, as well as effects on patient-reported outcomes, morbidity, mortality, and long-term harms.
Enhanced weight loss following coadministration of pramlintide with sibutramine or phentermine in a multicenter trial. [2010.09]
Preclinical evidence suggests that pharmacotherapy for obesity using combinations of agents targeted at distinct regulatory pathways may produce robust additive or synergistic effects on weight loss. This randomized placebo-controlled trial examined the safety and efficacy of the amylin analogue pramlintide alone or in combination with either phentermine or sibutramine...
Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs. [2010.05]
CONCLUSIONS: Adding pramlintide on a background of basal insulin improved some aspects of treatment satisfaction and quality of life relative to adding rapid-acting insulin analogs.
Comparison of the post-meal glucose response to different insulin bolus waveforms in insulin pump- and pre-meal pramlintide-treated type 1 diabetes patients. [2010.02]
BACKGROUND: Both pramlintide and insulin pump waveforms separately provide improved post-meal glucose control. However, when used together there may be a mismatch in actions leading to hypoglycemia. We studied the three currently available waveforms and a "modified combination wave" (MC) in pramlintide-treated patients. The MC was a "square" (SQ) wave combined with a "standard" (ST) bolus that was delayed 1 h into the mealtime... CONCLUSIONS: For currently available insulin pump bolus waves, SQ and MC may be least likely to cause hypoglycemia in pramlintide-treated patients.
A pilot trial of pramlintide home usage in adolescents with type 1 diabetes. [2009.11]
OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of home pramlintide use in adolescents with type 1 diabetes... CONCLUSIONS: Pramlintide can help some adolescents to decrease postprandial hyperglycemia, HbA1c values, body weight, and insulin dosages. Additional large-scale trials should now be considered.
Clinical Trials Related to Symlin (Pramlintide Subcutaneous)
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus [Completed]
This study will be the first evaluation of Symlin in adolescent subjects with type 1
diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics),
biochemical and physiological effects (pharmacodynamics), and safety and tolerability of
Symlin in these subjects.
Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus [Not yet recruiting]
This study is designed to investigate the clinical efficacy and safety of pramlintide
co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously
via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the
desired level of glycemic control using insulin therapy.
The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes [Recruiting]
The purpose of this study is to see if giving study drugs before a meal may lower blood
sugars after the meal. An improvement in blood sugar control may prevent long-term problems
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia [Completed]
The main purpose of the study is to determine the effects of 16 weeks of adjunctive
pramlintide or exenatide use on glycemic control in Type 1 Diabetes.
Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus [Active, not recruiting]
The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who
do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin«) 3 times daily
with expected glucose control require higher than FDA approved dosage.
The primary objective of the study is to determine whether higher doses of pramlintide
(Symlin«) in patients with type 2 diabetes mellitus control glucose better than the FDA
approved dose of 120 mcg three times daily.
The secondary objectives include proving whether higher dose pramlintide (Symlin«) is more
efficacious in causing weight loss and reduction in waist circumference than standard dose
pramlintide (Symlin┬«),to determine whether blood levels of certain hormones correlate with
need for higher dose therapy,and to determine whether or not the rate of common adverse
effects exceeds the maximum FDA approved pramlintide (Symlin┬«) dose of 120 mcg three times
Reports of Suspected Symlin (Pramlintide Subcutaneous) Side Effects
Loss of Consciousness (3),
Glycosylated Haemoglobin Increased (3),
Blood Glucose Increased (3),
Respiratory Distress (3),
Blood Glucose Decreased (3),
Wrong Technique in Drug Usage Process (2),
Weight Increased (2), more >>
Page last updated: 2011-12-09