FDA approves drug Tirzepatide for type 2 diabetes
- A new drug to treat type 2 diabetes has received approval from federal regulators.
- The drug tirzepatide is a weekly injection that helps people manage blood sugar levels and reduce food intake.
- Experts say clinical trial results indicate that tirzepatide is a promising new treatment for type 2 diabetes.
The Food and Drug Administration (FDA) has
In the past
“Tirzepatide showed robust improvements in glycemic control and body weight, without an increased risk of hypoglycemia,” the researchers wrote.
In late April, officials at Eli Lilly, the maker of tirzepatide, reported that their drug worked well in a Phase 3 weight loss trial for obese people.
The drug is a once-a-week injection that helps people manage blood sugar levels after meals and reduces food intake by creating a feeling of fullness.
“Tirzepatide is a dual incretin agonist drug. Incretins are hormones released by the gut to help manage blood sugar after a meal. Incretins induce the pancreas to release glucose-lowering insulin while blocking glucagon, which would raise glucose levels by mobilizing it from hepatic storesDr. Robert Gabbay, scientific and medical director of the American Diabetes Association, told Healthline.
“Incretins also delay stomach emptying, which slows the appearance of glucose in the circulation and promotes satiety,” he said.
In the case of diabetes, an A1C level refers to a person’s blood sugar level.
An A1C test measures the average blood sugar level over a 3 month period. The higher the A1C level, the higher the risk of diabetes complications.
“Poor glycemic control increases the risk of diabetes complications such as retinopathy, nephropathy, neuropathy and cardiovascular disease,” Gabbay said. “[The] The American Diabetes Association recommends an A1C goal of less than 7%.
“In people with type 2 diabetes and overweight or obesity, modest weight loss improves glycemic control and reduces the need for hypoglycemic drugs, and more intensive dietary restriction can significantly reduce A1C and blood sugar fasting and promote sustained disease remission,” he said. mentioned.
However, many people with type 2 diabetes struggle to meet their A1C goals through diet and exercise alone. This is where tirzepatide might come in handy.
In clinical trials, researchers reported that a significant number of participants who received tirzepatide achieved A1C levels below 7%.
“With the highest dose, they were seeing an average drop of 2.0 in A1C, which is just amazing when they start with an A1C of 8%. We don’t see that with any other agent we have. right now,” Dr. Laurie A. Kane, an endocrinologist at Providence Saint John’s Health Center in Santa Monica, Calif., told Healthline.
” It’s really unbelievable. The weight loss is as good or better than any of our weight loss drugs that we have on the market right now,” she added.
In clinical trials, 75% of participants receiving a 5 milligram (mg) dose of tirzepatide achieved an A1C of less than 7%.
Approximately 83% of participants receiving a 10mg dose achieved an A1C of less than 7% and 85% of participants receiving a 15mg dose achieved an A1C of less than 7%.
Kane said the approval of tirzepatide is good news for people with type 2 diabetes because the results associated with the drug are better than other drugs currently available.
“We know that anything that helps them lose weight will always improve their diabetes control, which will almost certainly lower blood sugar,” she said.
“Whether it’s lifestyle, medications, supplements, or surgery, weight loss always improves glycemic control. And the amount of weight loss the greater the glycemic control of the agent [tirzepatide] is better than anything we have right now,” Kane said.
Gabbay agreed that the trial results are promising.
“The SURPASS trials continue to show that tirzepatide is associated with impressive reductions in A1C and body weight, without a significant increase in hypoglycemia in people with type 2 diabetes. The SURPASS-4 trial showed that participants maintained A1C and weight reductions for up to 2 years without undue cardiovascular risk,” he said.
“[Tirzepatide] will be an important addition to our tools to help manage people’s diabetes,” Gabbay said. “The majority of my patients with type 2 diabetes are overweight and would therefore benefit from this treatment. It could also be a wonderful tool soon after diagnosis to help people with diabetes go into remission.