- May 9, 2020 / BIOON / — Eli Lilly recently released new 36 week data for the evaluation of high-dose trulicity (dulaglutide) treatment of type 2 diabetes mellitus stage III award-11 trial.
- The results showed that compared with the 1.5mg dose of trulicity, the 4.5mg dose of trulicity significantly reduced the blood glucose level (A1C) from the baseline level in two main statistical methods (efficacy evaluation and treatment plan evaluation).
- Trulicity is a glucagon like peptide-1 (GLP-1) receptor agonist (RA), injected once a week, which has also been approved, combined with diet control and exercise, to improve blood glucose control in adult patients with type 2 diabetes.
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May 9, 2020 / BIOON / — Eli Lilly recently released new 36 week data for the evaluation of high-dose trulicity (dulaglutide) treatment of type 2 diabetes mellitus stage III award-11 trial.
The trial evaluated the efficacy and safety of high doses (3 and 4.5 mg) and approved doses (1.5 mg) of trulicity. The results showed that high dose of trulicity (3 mg and 4.5 mg) was well tolerated. The A1C of patients with type 2 diabetes was reduced by 1.9% and 10.4 pounds (about 4.7 kg) compared with the baseline.
The results of the trial have been published in the Journal of the endocrinic society. Dr. Juan Pablo Frias, medical director and chief researcher of the National Research Institute (NRI), said: “the award-11 trial confirmed our expectation that a higher dose of the truccity study resulted in a significant reduction in blood sugar and weight in patients with type 2 diabetes compared to a 1.5mg dose of truccity. These promising data suggest that higher doses of trulicity may be a choice for clinicians in the treatment of patients with type 2 diabetes who need additional glycemic control due to the natural progression of the disease. “
Award-11 is a randomized, double-blind, parallel group III study. 1842 patients with type 2 diabetes were enrolled in the study. The safety and efficacy of two experimental doses (3.0mg and 4.5mg, once a week) and the approved dose of 1.5mg (once a week) were evaluated. The main purpose of the study was to demonstrate that in patients with type 2 diabetes who were treated with metformin but had poor blood glucose control, the once-a-week experimental dose was superior to the approved dose of 1.5mg for 36 weeks. Secondary and exploratory endpoints included mean body weight change, the proportion of patients with A1C < 7%, fasting blood glucose (FPG), and the incidence of hypoglycemia at 36 and 52 weeks of treatment.
The results showed that compared with the 1.5mg dose of trulicity, the 4.5mg dose of trulicity significantly reduced the blood glucose level (A1C) from the baseline level in two main statistical methods (efficacy evaluation and treatment plan evaluation).
These two methods are used to evaluate the efficacy of high dose.
Using the efficacy evaluation method: this method analyzes the subjects who are still receiving treatment, and the data shows that the dose of 3mg and 4.5mg achieves significantly better A1C and weight loss compared with the dose of 1.5mg.
Using the treatment plan evaluation method: each dose resulted in significant reduction of A1C and body weight, but only 4.5mg dose showed superiority compared with 1.5mg dose. The specific data are as follows: (1) A1C decreased: – 1.8% (4.5mg), – 1.6% (3mg), – 1.5% (1.5mg). (2) Weight loss: – 10.1 lbs (- 4.6kg, 4.5mg), – 8.4 lbs (- 3.8kg, 3mg), – 6.6 lbs (- 3.0kg, 1.5mg).
In both analyses, the majority of patients receiving high doses met the A1C < 7% treatment goal recommended by the American Diabetes Association.
In this study, the safety and tolerability characteristics of high-dose trulicity (3mg and 4.5mg) were consistent with the known trulicity 1.5mg characteristics. The most common adverse events in each dose were related to the gastrointestinal tract.
Dr Dawn Brooks, head of global development at Lilly Trulicity, said: “diabetes is a complex disease and over time additional treatment may be needed to maintain blood sugar control. That’s why we studied higher doses of truccity, the largest prescription GLP-1 receptor agonist in the United States. We are encouraged by these data and the potential to provide new treatment options for patients with type 2 diabetes who may need to improve their treatment options based on existing treatment experience. “
The 52 week results of the award-11 study are consistent with the 36 week results, and further details will be published later. The results of the award-11 study have been submitted to us and European regulators for review.
Trulicity is a glucagon like peptide-1 (GLP-1) receptor agonist (RA), injected once a week, which has also been approved, combined with diet control and exercise, to improve blood glucose control in adult patients with type 2 diabetes.
In February 2020, trulicity was approved by the US FDA as a new indication to reduce the risk of major adverse cardiovascular events (MACE) in adult patients with type 2 diabetes mellitus who have cardiovascular (CV) disease or have multiple cardiovascular risk factors. It is worth mentioning that this approval makes trulicity the first type 2 diabetes drug approved to reduce the risk of mace in primary and secondary prevention population.
GLP-1 RA is one of the most attractive drugs in diabetes. GLP-1 RA is not insulin, but a new type of insulin secretion promoting agent. Its mechanism is similar to that of natural hormone GLP-1. It can promote the body’s own insulin secretion when patients eat. It has the advantages of strong hypoglycemic effect, low hypoglycemic risk, weight-loss effect and cardiovascular benefits.
Since its launch in the US in 2014, trulicity has become the largest prescription glp-1ra. In addition to proven hypoglycemic benefits and easy-to-use devices, trulicity can now be used to help patients with type 2 diabetes reduce the risk of cardiovascular events. Evaluatepharma, a pharmaceutical market research firm, predicts that trulicity’s sales will reach 7.13 billion US dollars in 2024, making it the world’s best-selling antidiabetic drug. (Biovalley Bioon.com )
Source of original text: higher investment does of authenticity? (dulaglutide) meaningfully reduced A1C and body weight in people with type 2 diabetes
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