Weight Loss Injections For Type 2 Diabetes – TRENTON, N.J. US regulators on Tuesday approved a new diabetes drug that lowers blood sugar levels and helps people lose weight. Danish drugmaker Novo Nordisk says the Food and Drug Administration has approved a weekly spray for people with type 2 diabetes. Ozempic, also known as semaglutide, works by stimulating the body’s insulin production and reducing appetite.
In a large study funded by Ozempic, the average person lowered their blood sugar level by at least 2 times more than Merck’s popular daily diabetes pill, Januvia & Co. It also helped study participants lose two to three times more weight than those in the comparison group.
Weight Loss Injections For Type 2 Diabetes
Over 56 weeks, patients on low-dose Ozempic lost an average of 9.5 pounds (4.3 kg), while those on high-dose doses lost 13.5 pounds (6.1 kg). Patients who took Januvia lost an average of 4 pounds (1.9 kg).
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Novo Nordisk, a leader in diabetes care, also tested separate drugs for weight loss alone.
Many patients with type 2 diabetes are overweight, and frequent weight loss can often help them lower their blood sugar and better manage their diabetes. Over time, high blood sugar can damage many organs and impair blood circulation.
The new drug is available in an injection pen and costs the same as the weekly dose: $ 676 for a 4- to 6-week uninsured supply. Novo Nordisk already sells a similar daily spray, Victoza.
Ozempic competes with other popular drugs once a week in the same class, including Eli Lilly and Co.’s Trulicity. And Bydureon of AstraZeneca PLC, which produces less weight. However, they all have warnings of possible side effects, including kidney damage and pancreatitis. It can also be associated with thyroid cancer, so those taking all medications in the class are tracked through the patient list. .
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First reported “game change” approval of GLP-1 receptor agonist semaglutide 2.4 mg (Wegovy) for chronic weight management. As part of our annual top story review, we keep track of what has happened since this approval.
The FDA has approved the GLP-1 receptor for chronic weight management in overweight adults (BMI of 30 or more) or in obese adults (BMI 27 or more) and at least some conditions. Related to weight, such as high blood pressure. Pressure, type 2 diabetes. Or high cholesterol used in conjunction with a low-calorie diet and exercise.
As the first drug approved for this indication since 2014, the green light for semaglutide was immediately met with a wave of enthusiasm from the healthcare community.
Caroline M. Apovian, MD, from Brigham and Women’s Hospital in Boston, said: Bariatric surgery ”. Published by The Obesity Society. “The new agency offers almost double the weight loss (10 to 20%), while the current agency on the market (5 to 10%) is closer to the 25 to 30% stable weight loss seen in Surgery.
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Part of the excitement about this new agent is the remarkable weight loss it has shown in the Semaglutide Treatment Program in Obese People (STEP), which supports FDA approval. One installment of this program – Phase 1 study showed an average reduction of 14.9% of basal body weight after 68 weeks of treatment, compared to only 2.4% in the placebo group and lifestyle alone. For adults with BMI. 30 or more.
“I was surprised and delighted to see the unprecedented results of the drug,” said investigator Robert Kushner, MD of Northwestern University Feinberg School of Medicine in Chicago.
. “The fact that 50% of participants can lose at least 15% of their initial body weight and the third lose at least 20% of their body weight is a game changer.”
And in Phase 2 trials, injecting Semaglutide 2.4 mg once a week also showed significant weight loss in people with a BMI of at least 27 and type 2 diabetes.
New Diabetes Injection Offers Added Benefit Of Weight Loss
After its adoption, concerns arose about the cost of the new treatment. With a monthly wholesale cost of about $ 1,350, a 20-year treatment would cost more than $ 323,000. This is about 58% lower than the pen value Semaglutide used for type 2 diabetes (Ozempic), although it has the same dose of Maglutide as Ozempic.
The price increase does not seem to deter patients or officials as Semaglutide almost flew off the shelf after hitting the market immediately after it was approved in June. But initial demand for the new weight loss drug appears to be “oversupplied”, according to analyst Jefferies, which could lead to delays in prescribing. Despite concerns about these initial stocks, Novo Nordisk chairman and CEO Lars Fruergaard Jørgensen said demand remained strong in the fall, which “exceeded [Novo Nordisk] expectations. Strong, highlighting the huge needs of obese people. “
With this commercial success, the company has expanded its development pipeline. The 50-mg oral version of semaglutide is in process for chronic weight management based on the oral formula of semaglutide (Rybelsus) used in doses of 7 and 14 mg for type 2 diabetes.
And in November, another STEP treatment program was unveiled at the ObesityWeek 2021 virtual meeting. In the Phase IIIb phase 5 study, semaglutide showed sustained weight loss during the second phase. Compared with placebo, those who received active treatment combined with diet and exercise saw a significant reduction of 12.6% from baseline body weight at 104 weeks.
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“Obese people try to lose weight an average of seven times before they seek medical help. When weight is lost, it usually returns, so it is very important to find ways to help people with the disease. “Obesity loses weight and controls it,” said W. Timothy Garvey, MD, University of Alabama, Birmingham. “We can lose weight while taking Wegovy and continue to lose weight for two years, which can help us better treat and manage chronic obesity.”
However, in late December, Novo Nordisk announced that it was facing supply chain problems. Contract manufacturers that fill semaglutide syringes have temporarily stopped manufacturing and supplying products to the US market.
“As a result, Novo Nordisk is not expected to meet US requirements in the first half of 2022, and a few new patients are expected to begin treatment,” the company statement read. He added that priority would be given to patients who have already begun treatment. In the United States, the supply chain turmoil is also not expected to be fully resolved until the second half of 2022. Another successful weekly weight loss trial of GLP-1 – effective in diabetics with a BMI of less than 27
A manufacturer-sponsored study on the efficacy of Semaglutide found that when combined with a once-a-week lifestyle administration, Semaglutide (Ozempic) led to significant weight loss in obese people with dehydration. Type 2 diabetes.
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In a large phase III trial of more than 1,200 adults with a body mass index (BMI) of at least 27, those with 2.4 mg of subcutaneous semaglutide per week lost an average of 9.6% of subsequent basal body weight. From 68 weeks of treatment compared to 3.4. Percentage of those taking placebo and lifestyle alone (difference of treatment -6.2 percentage points, 95% CI -7.3 to -5.2,
The study, published online in The Lancet, included a third treatment group of patients who received 1.0 mg of semaglutide once a week – an approved dose for type 2 diabetes. As a single dose of 0.5 mg). After 68 weeks of treatment, the group had an average reduction of 7% of basal body weight.
At week 68, patients with 2.4 mg per week of semaglutide were five times more likely to achieve at least a 5% reduction in body weight compared to placebo (OR 4.88, 95% CI 3.58-6.64). ,
In total, about 69% of those on 2.4 mg semaglutide were able to reduce at least 5% of their initial body weight – completing the endpoints of other trials – compared to 29% of lifestyle interventions. Alone. About 57% of those on 1 mg experienced 5% weight loss.
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In addition to the weight-loss benefits of those taking 2.4 mg of semaglutide, the researchers also reported significant improvements in waist circumference, systolic blood pressure, fat profile, signs of inflammation and physical activity.
In addition, not surprisingly, significant improvements were also seen in blood glucose, with 68% of those with high levels achieving HbA1c of 6.5% or lower. More than 79% can reach a figure below 7%.
These findings build on the recently reported Phase 1 test in the Semaglutide test. For obese adults (BMI)
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