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The drug is developed and marketed by Boehringer Ingelheim Pharmaceuticals in collaboration with Eli Lilly and Company.
Empagliflozin received marketing authorisation from the European Commission (EC) for use in the EU in May 2014. The EC approved empagliflozin’s 10mg and 25mg once-daily tablets for use when diet and exercise alone are not sufficient to control blood sugar levels, for patients intolerant to metformin and as a parallel to other glucose controlling medicines such as insulin.
Jardiance was approved by the US Food and Drug Administration (FDA) in August 2014 as an adjunct to diet and exercise, as well as to improve blood glucose levels in patients with Type 2 diabetes.
The drug was also approved by the FDA and the EC to reduce the risk of patients with Type 2 diabetes developing cardiovascular disease in December 2016 and January 2017 respectively. The approval was based on the positive results of the EMPA-REG OUTCOME trial.
Type 2 diabetes causes
The first patient enrolled in the cardiovascular safety and renal microvascular outcome study with linagliptin, 5mg once daily in patients with type 2 diabetes.
Also known as non-insulin dependent diabetes, Type 2 diabetes is a condition where the body is unable to use the insulin it produces efficiently, which eventually leads to insulin deficiency. It accounts for 90-95% of all diabetic cases.
Type 2 diabetes is more likely to affect people that are elderly, obese or have a history of the disease in their family.
Approximately 29 million Americans and an estimated 382 million people worldwide are diagnosed with either Type 1 or Type 2 diabetes.
Jardiance’s action mechanism
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Type 2 diabetics are affected by higher blood sugar levels due the 1 last update 25 May 2020 to a greater presence of SGLT2 proteins, responsible for the reabsorption of glucose into the bloodstream.Type 2 diabetics are affected by higher blood sugar levels due to a greater presence of SGLT2 proteins, responsible for the reabsorption of glucose into the bloodstream.
Jardiance reduces glucose reabsorption capacity in the kidneys, which results in urinary glucose excretion and controls blood sugar levels. Unlike other Type 2 diabetes drugs, empagliflozin and other SGLT2 inhibitor-class drugs work independently of beta-cell (β-cell) function and insulin pathways.
Jardiance is available in 10mg and 25mg tablet form for oral administration.
Clinical trials of Jardiance
The FDA’s approval for Jardiance was based on two Phase III clinical trials conducted on Type 2 diabetics. One study compared the efficacy of Jardiance as monotherapy with placebo, while the other tested the drug in combination with other diabetes drugs such as metformin, sulfonylurea, pioglitazone and insulin.
The results showed a significant reduction in the haemoglobin A1c (HbA1c) levels of Type 2 diabetes patients.
The first trial studied Jardiance used as a monotherapy. This double-blind, placebo-controlled study enrolled 986 Type 2 diabetics to evaluate the safety and efficacy of Jardiance in comparison with a placebo.
The subjects initially entered a 2-week open-label placebo run-in period. At the end of the second week, patients with inadequately controlled Type 2 diabetes and haemoglobin levels between 7% and 10% were randomised to Jardiance 10mg, Jardiance® 25mg, placebo, or a reference comparator.
“Type 2 diabetes accounts for 90% to 95% of all diabetic cases.”
Measured during the 24th week of the study, the results demonstrated significant reductions in HbA1c levels, fasting glucose levels and body weight in subjects treated with Jardiance compared with placebo-treated patients.
The second study was a double-blind, placebo-controlled study that enrolled 637 Type 2 diabetics to evaluate the safety and efficacy of Jardiance® in combination with metformin. In this study, Type 2 diabetics with inadequately controlled blood sugar levels while taking at least 1,500mg of metformin per day entered an open-label two-week placebo run-in period. At the end of the two weeks, the subjects were randomised to placebo and Jardiance.
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The EMPA-REG OUTCOME clinical trial was a long-term, multi-centre, randomised, double-blind placebo-controlled trial that enrolled nearly 7,000 Type 2 diabetes patients with cardiovascular disease from 42 countries. The trial demonstrated a 38% decrease in deaths from cardiovascular disease and a 32% decrease in mortality in patients receiving Jardiance compared to placebo for 3.1 years.
The trial also demonstrated a positive impact of Jardiance in extending the life span of patients with Type 2 diabetes and cardiovascular disease by one to four and a half years, compared with placebo.
The most common adverse effects recorded were urinary tract infections and vaginal yeast infections. Hypoglycaemia was commonly reported in patients that received a combination of Jardiance and sulfonylurea or insulin.
Other side effects included weakness, headaches, confusion, hunger, drowsiness, sweating, kidney problems and a rise in cholesterol.