Amylin analog · insulin-treated diabetes
Pancreatic beta cells store amylin in the same granules as insulin and release the two together when food arrives; pramlintide is an injectable analog of amylin in which three amino acids are replaced with proline1. The FDA approved it, as Symlin, for add-on use in people with type 1 or type 2 diabetes who take mealtime insulin yet still fall short of their glucose targets despite optimal insulin therapy1. Drugs@FDA now lists all Symlin products as discontinued.
In both type 1 and type 2 diabetes, the pancreas releases less amylin, as well as less insulin, in response to food1. Pramlintide stands in for the missing amylin. In human studies it slows how fast the stomach empties and blunts the after-meal rise in glucagon, a hormone that makes the liver release sugar. It also adds to feelings of fullness, so people eat fewer calories1. Together these effects slow how quickly glucose enters the blood after a meal. Human amylin tends to clump, so pramlintide was based on the non-clumping rat amylin structure. It acts on amylin receptors, which are built around the calcitonin receptor, and much of its effect on appetite comes from the brain2.
The label's efficacy data come from 26- to 52-week placebo-controlled trials in people already using insulin1. In a 52-week study of 480 people with type 1 diabetes, HbA1c fell by 0.67 percentage points by week 13 with pramlintide versus 0.16 with placebo. A significant difference held through week 52, and people lost a little weight on average instead of gaining3.
In a 52-week study of 656 insulin-treated people with type 2 diabetes, the highest-dose regimen lowered HbA1c by about 0.6 points, significantly more than placebo, with modest weight loss while the placebo group gained slightly4. It was also studied in people with obesity but without diabetes.
In a trial of 411 people on a lifestyle program, two regimens produced about 6% to 7% more weight loss than placebo at 12 months, although only 146 people were still evaluable by then and the last eight months were single-blind5. It was never approved for weight loss.
FDA-approved in 2005 as Symlin (now AstraZeneca) as an add-on for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals1. Drugs@FDA now lists every Symlin product as discontinued.
The FDA label carries a boxed warning: used with insulin, it raises the risk of severe low blood sugar, especially in type 1 diabetes. These episodes usually come within three hours of an injection1. The label calls for lowering mealtime insulin at the start and checking glucose often. Common side effects are nausea, vomiting, loss of appetite and headache; nausea usually eased over time1,3. It is contraindicated with hypoglycemia unawareness or confirmed gastroparesis. Because it slows stomach emptying, it can delay absorption of oral medicines1.
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