Stage (next event)
Phase 2 (FDA Meeting)
Catalyst Info & Data Links
TITLE: Pramlintide-Insulin for Type 1 & 2 Diabetes - Phase 2 FDA Meeting
ClinicalTrials.gov (NCT04074317): Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
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WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Mechanism of Action
MECHANISM OF ACTION
Pramlintide is an analog of amylin, a natural hormone that inhibits glucagon secretion, delays gastric emptying, and is known to help increase satiety. Pramlintide is indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy. It works by slowing the movement of food through the stomach. This prevents blood sugar from rising too high after a meal and may decrease appetite and cause weight loss. Pramlintide use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes.
There are 22.1M persons with diabetes in the US (T1D & T2D), where 6.2M currently use insulin
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