First Triple-Combination Diabetes Drug Got Approval of FDA

This Monday, the Food and Drug Administration approved the first triple-combination therapy to manage diabetes type 2. This drug is a combination of three different diabetes medicines, including metformin hydrochloride extended-release, linagliptin (DPP-IV inhibitor), and empagliflozin (SGLT2 inhibitor).

Trijardy XR, the triple combination drug, was approved for adults with diabetes type 2 due to its effectiveness in decreasing blood sugar levels (BSLs) when used along with exercise and a healthy diet.

Diabetes type 2 is a chronic condition that results in increased BSLs due to the body’s insufficiency to use insulin. Up till now, there is no therapy available to completely treat this condition, but further complications can be prevented by managing blood sugar levels and keeping them under control.

In most the patients, the condition can be improved by doing exercise or having a healthy diet. But some of the individuals suffering from diabetes type 2 may need insulin or some other medicine for its management.

Ralph A. DeFronzo is the Managing Director of the UT Health Science Center’s diabetes research unit, at San Antonio. In a press release from Eli Lilly and Co and Boehringer Ingelheim (pharmaceutical companies), DeFronzo said that among patients suffering from this chronic illness, many have already adopted a treatment plan consisting of multiple drugs.

But despite this measure, some adults may face difficulty in keeping their blood sugar levels near the normal values and hence these patients need some other agents to attain their goals of HbA1c.

In this therapy, the novel medication used keeps BSLs under control and permits the diabetic patients to take different antidiabetic medicines to improve the level of BSLs or glycemic control. Having 3 different diabetes drugs in the form of a pill is another way towards the management of diabetes.

Also read: Medial EarlySign’s New Model Can Detect Prediabetic Patients at Greater Risk of Diabetes

In the United States, both linagliptin (trade name: Tradjenta, by li Lilly’s and Boehringer Ingelheim pharmaceutical company) and empagliflozin (trade name: Jardiance, by li Lilly’s and Boehringer Ingelheim pharmaceutical company) have also got approval for decreasing BSLs in adults with diabetes type 2.

In 2016, the FDA granted approval to empagliflozin for one of its other functions. Along with lowering blood sugar levels, this drug was also found to be helpful in decreasing the chances of cardiovascular deaths among individuals suffering from chronic illnesses like CVD and diabetes type 2.

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Moreover, in June, the drug – empagliflozin had also received fast track designation by FDA for its reduction in the risk of cardiovascular deaths and hospitalization related to chronic heart failure.

In the CARMELINA trial, the effect of drug linagliptin on the progression of renal disease and the risk of CV death were checked by the researchers. Whereas, the results of the trial were reported in June by Healio at the American Diabetes Association Scientific Sessions.

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The results of the trial indicated that whatever is the patient’s age or the level of his renal impairment, there was no increase in the risk of renal disease progression or a new cardiovascular event. Besides this, a cohort of 6000 people suffering from type 2 diabetes was also analyzed to compare the effects of linagliptin and sulfonylurea glimepiride.

As a result, it was found that there were no differences between the group for the incidence of CV death, nonfatal stroke, and myocardial infarction.

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