In a nutshell
This study looked at the safety and effectiveness of tirzepatide (LY-3298176) in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise alone. It found that compared to placebo, tirzepatide improved diabetes control and weight in these patients.
Some background
In T2D, there is a resistance of the cells to the hormone insulin made by the pancreas. Therefore, glucose builds up in the bloodstream. However, in time, the pancreas stops producing enough insulin. The first line of treatment is usually diet and exercise. These can increase sensitivity to insulin of cells and tissues of the body. However, many patients with T2D cannot adequately control their blood glucose with diet and exercise, and even standard diabetes medication. New therapies are needed for these patients.
Tirzepatide is a new treatment for T2D. It is given in the form of a weekly injection under the skin. It works by activating certain gut hormones that result in a release of insulin and a blockage of glucagon hormones in the pancreas. It is not clear how safe and effective tirzepatide is when given alone in patients with T2D that were not well managed by diet and exercise.
Methods & findings
This study involved 478 patients with T2D inadequately controlled by diet and exercise alone. Patients were divided into four groups. Group 1 received tirzepatide 5 mg, group 2 received tirzepatide 10 mg, group 3 received tirzepatide 15 mg and group 4 received a placebo for 40 weeks. Blood glucose control was evaluated through the HbA1c levels.
After 40 weeks, all tirzepatide treatment groups had achieved a reduction in HbA1c levels of 1.87-2.07% compared to the placebo group that had an increase of 0.04%. Significantly more patients in the tirzepatide groups achieved an HbA1c target below 7% (87-92%), 6.5% (81-86%), or 5.7% (31-50%) after 40 weeks compared to the placebo group (1-19%).
Tirzepatide treatment also resulted in weight loss of 7-9.5 kg compared to placebo (0.7 kg) after 40 weeks. Patients in the tirzepatide groups also had reductions in cholesterol and triglyceride levels compared to the placebo group.
Side effects of stomach upset occurred in up to 18% of the tirzepatide groups. There were no instances of serious hypoglycemia (dangerously low blood glucose levels) associated with tirzepatide treatment.
The bottom line
This study showed that tirzepatide is a safe and effective treatment for patients with T2D inadequately controlled with diet and exercise.
The fine print
This study was funded by Eli Lilly and Company, the manufacturer of tirzepatide.
Published By :
Lancet (London, England)
Date :
Jun 25, 2021
