FDA Approves Drug Tirzepatide for Type 2 Diabetes

Experts say the new drug tirzepatide shows promise in managing blood glucose levels and helping people with type 2 diabetes reduce their food intake.

Experts say a new drug shows promise for helping people with type 2 diabetes manage their blood glucose levels. Fertnig/Getty Images
  • A new drug to treat type 2 diabetes has received approval from federal regulators.
  • The drug tirzepatide is a once-a-week injection that helps people manage blood glucose levels and reduce food intake.
  • Experts say the clinical trial results indicate that tirzepatide is a promising new treatment for type 2 diabetes.

The Food and Drug Administration (FDA) has approved a new drug for people with type 2 diabetes.

In past clinical trials, the drug tirzepatide improved glycemic control and assisted with weight loss in people with type 2 diabetes.

“Tirzepatide showed robust improvements in glycemic control and body weight, without increased risk of hypoglycemia,” the researchers wrote.

In late April, officials at Eli Lilly, the manufacturer of tirzepatide, reported their drug performed well in a phase 3 weight loss trial for people with obesity.

The drug is an injection taken once a week that helps people manage blood glucose levels after meals and reduces food intake by creating a sense of fullness.

“Tirzepatide is a dual incretin agonist drug. The incretins are hormones released by the gut to help manage blood glucose levels after a meal. Incretins trigger the pancreas to release glucose-lowering insulin while blocking glucagon, which would raise glucose levels by mobilizing it from liver stores,” Dr. Robert Gabbay, the chief scientific and medical officer for the American Diabetes Association, told Healthline.

“Incretins also delay emptying of the stomach and this slows the appearance of glucose in the circulation and promotes satiety,” he said.

The issues with blood sugar levels

In 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 complications from diabetes.

“Poor glycemic control increases the risk of diabetes complications such as retinopathy, nephropathy, neuropathy, and cardiovascular disease,” Gabbay said. “[The] American Diabetes Association recommends an A1C goal of less than 7 percent.”

“In people with type 2 diabetes and overweight or obesity, modest weight loss improves glycemic control and reduces the need for glucose-lowering medications, and more intensive dietary restriction can substantially reduce A1C and fasting glucose and promote sustained remission of the disease,” he said.

However, many people with type 2 diabetes find it challenging to reach their A1C goals through diet and exercise alone. This is where tirzepatide might be helpful.

In the clinical trials, researchers reported that a significant number of participants prescribed tirzepatide achieved an A1C of less than 7 percent.

“With the highest dose, they were seeing an average 2.0 lowering of the A1C, which is just incredible when they’re starting with an A1C of 8 percent. We don’t see that with any other agents that we have right now,” Dr. Laurie A. Kane, an endocrinologist at Providence Saint John’s Health Center in Santa Monica, California, told Healthline.

“That’s really incredible. The weight loss is as good or better than any of our weight loss medicines we have on the market now,” she added.

In the clinical trials, 75 percent of participants on a 5-milligram (mg) dose of tirzepatide achieved an A1C of less than 7 percent.

About 83 percent of participants on a 10-mg dose achieved an A1C of less than 7 percent, and 85 percent of participants on a 15-mg dose achieved an A1C lower than 7 percent.

How the drug could help

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 those from other drugs currently available.

“We know anything that helps with weight loss is always going to improve their diabetes control, that will lower blood sugars almost without a doubt,” she said.

“Whether it’s lifestyle, medication, supplements, or surgery, weight loss always improves glycemic control. And the amount of weight loss plus glycemic control from the agent [tirzepatide] is better than anything we have right now,” Kane said.

Gabbay agreed the results of the trials are promising.

“The SURPASS trials continue to show tirzepatide is associated with impressive A1C and body weight reductions, with no significant increase in hypoglycemia in people with type 2 diabetes. The SURPASS-4 trial showed that participants maintained A1C and weight reductions up to 2 years with no excess cardiovascular risk,” he said.

“[Tirzepatide] will be a significant addition to our tools to help manage people’s diabetes,” Gabbay said. “The majority of my patients with type 2 diabetes are overweight, and therefore would benefit from this treatment. It also could be a wonderful tool early after diagnosis to help people with diabetes enter remission.”

This story originally appeared on: Healthline.com - Author:Elizabeth Pratt

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