Thank You, Gila Monster: A New Drug for Type-2 Diabetes Promotes Significant Weight Loss in Pre-Diabetic Obese People As Well

T2D Diabetes 597 views
Written by Timothy Pfaff

OzempicĀ®, the brand name for the compound semaglutide, shows promise of significant weight loss in people with type-2 diabetes and pre-diabetes.

Thank You, Gila Monster: A New Drug for Type-2 Diabetes Promotes Significant Weight Loss in Pre-Diabetic Obese People As Well

We’re starting our story with the ad-line from the drug maker’s home page: “Once-weekly Ozempic® now available in pharmacies.” Underline: “Ozempic® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.”

[We’re neither selling nor pushing drugs. We made a pledge not to write about new cancer drugs until they were in some realistic way available to readers. We’re now bringing that policy forward for the site as a whole.]

The very recent news in the popular press is just now catching up with a study presented at ENDO 18, the Endocfrine Society’s 100th-annivesary meeting in Chicago on March 18. As summarized in a report in Science Daily, “A compound that mimics a naturally occurring hormone that regulates appetite may help people who have obesity but not diabetes to lose weight.”

While Ozempic® is, as stated, designed for people with type-2 diabetes, Science Daily added that its core compound, semaglutide, “mimics a naturally occurring hormone that regulates appetite may help people who have obesity but not diabetes to lose weight.” It was approved by the U.S. Food and Drug Administration last December.

Semaglutide was discovered in 2012 and developed by the Danish company Novo Nordisk. Marketed as Ozempic®, it is available in both oral and injectable forms. In Wikipedia’s concise description, “As a glucagon-like peptide-1 receptor agonist, it lowers the blood sugar level by increasing the production of insulin.” 

In its press release, Novo Nordisk, calls semaglutide an “analog of human GLP-1 that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.” There’s a more detailed description, in technical language, here.

While it was developed for, and marketed as, a new drug for the treatment of type-2 diabetes, what’s predictably making the headlines in the popular press are the trials that indicate that Ozempic® can bring about significant weight loss in obese people. That expands its target to concerned people with chronic obesity who remain “pre-diabetic.”

As reported in the lay press

Reporting on the drug’s final-stage trials on February 22, 2018, Reuters wrote, in a rather eerie conclusion, “The once-daily pill belongs to a blockbuster class of treatments known as GLP-1s that stimulate insulin production, the first of which were derived from the venomous bite of North America’s Gila monster lizard.”

But the more attention-getting news was in the middle of its article, to wit: “Novo Nordisk said the first of 10 phase III trials were successful in its primary objective by demonstrating 'significant and superior' improvements in long-term blood sugar compared to a placebo.

“The trial also showed that the highest of the three tested doses - 3, 7 and 14 mg - demonstrated 'significant and superior' weight loss. While weight loss was observed for the two smaller doses, they did not reach statistical significance.”

In a description of the final trials—in which it called semaglutide a once-a-day pill—the Nasdaq GlobalNewswire reported: “Novo Nordisk said the first of 10 phase III trials were successful in its primary objective by demonstrating “significant and superior” improvements in long-term blood sugar compared to a placebo.

“The trial also showed that the highest of the three tested doses - 3, 7 and 14 mg - demonstrated ‘significant and superior’ weight loss. While weight loss was observed for the two smaller doses, they did not reach statistical significance.”

Articles in the scientific press

An article in European Pharmaceutical Review dated March 21, 2018, “Semaglutide may help people with obesity lose weight,” calls semaglutide “a naturally occurring hormone that controls appetite.”

It quoted Dr. Patrick M. O’Neil, professor of psychiatry and behavioral science and Director of the Weight Management Center at the University of South Carolina as saying, “This randomised study of weight loss induced with semaglutide in people with obesity but without diabetes has shown the highest weight reductions yet seen for any pharmaceutical intervention.” 

In a study of 957 people, “Sixty-five percent of participants who received 0.4 mg of semaglutide per day lost at least 10 percent of their body weight, compared with 10 percent of those in the placebo group and 34 percent of the liraglutide group.”

An article in the professional journal The Lancet also referred to semaglutide as a “once-weekly” “pill.” The conclusion in its “Interpretation” section was enthusiastic:

“At low and high doses, semaglutide was superior to dulaglutide in improving glycaemic control and reducing bodyweight, enabling a significantly greater number of patients with type 2 diabetes to achieve clinically meaningful glycaemic targets and weight loss, with a similar safety profile.”

In an article for the American Diabetes Association’s Diabetes Care, its conclusion was similarly plain-spoken: “Semaglutide 1.0 mg was superior to exenatide ER 2.0 mg in improving glycemic control and reducing body weight after 56 weeks of treatment; the drugs had comparable safety profiles. These results indicate that semaglutide treatment is highly effective for subjects with type 2 diabetes who are inadequately controlled on oral antidiabetic drugs.”

Finally, the European Medicines Agency, in its article on Ozempic®, wrote: 

“Studies showed that Ozempic is effective at lowering blood glucose levels and reducing the risk of health complications in patients with type 2 diabetes.

“Five studies in over 4,000 patients showed that Ozempic lowered levels of HbA1c (a measure of blood glucose) by between 1.2 and 1.8 percentage points over 10 to 13 months. Ozempic in these studies compared favourably with other treatments, sitagliptin, exenatide and insulin glargine (which led to reductions of 0.55, 0.92, 0.83 percentage points respectively) and placebo (reductions of up to 0.09 percentage points). In addition, the results indicated that treatment with Ozempic was associated with a beneficial fall in body weight.

“A further study in over 3,000 diabetes patients at high risk of heart problems showed that overall, heart attack, stroke or death occurred less frequently in patients treated with Ozempic (6.6%) than with placebo (8.9%). When looking at the three ‘events’ separately, fewer patients taking Ozempic had a heart attack or stroke, but rates of death from heart problems were similar in the two groups.”

Price

Predictably, prices are substantial.

Here is a list of retailers:

https://www.goodrx.com/ozempic (Costco, Albertsons, Safeway, Kroger)

https://www.drugs.com/price-guide/ozempic

https://www.ozempicpro.com/savings-and-support.html

Conclusion

The connection between obesity and the possible development of type-2 diabetes is well know. If you are obese and pre-diabetic or have type-2 diabetes, consult your physician about Ozempic®.

Sources/Reading:

https://www.sciencedaily.com/releases/2018/03/180318144816.htm

http://press.novonordisk-us.com/2016-12-05-Novo-Nordisk-Files-for-Regulatory-Approval-of-Once-Weekly-Semaglutide-with-the-FDA-for-the-Treatment-of-Type-2-Diabetes

https://en.wikipedia.org/wiki/Semaglutide

https://pubchem.ncbi.nlm.nih.gov/compound/Semaglutide#section=Top

https://globenewswire.com/news-release/2018/02/22/1379640/0/en/Novo-Nordisk-successfully-completes-the-first-phase-3a-trial-PIONEER-1-with-oral-semaglutide.html

https://www.fiercepharma.com/pharma/novo-nordisk-s-semaglutide-spurs-major-weight-loss-ph2-obesity-study

https://www.pharmaceutical-technology.com/news/novo-nordisk-obesity-semaglutide-trial/

https://www.europeanpharmaceuticalreview.com/news/73730/semaglutide-help-lose-weight/

http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30024-X/fulltext

https://www.medscape.com/viewarticle/889631

http://care.diabetesjournals.org/content/early/2017/12/14/dc17-0417

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004174/human_med_002211.jsp&mid=WC0b01ac058001d124

https://www.ozempicpro.com/savings-and-support.html

 

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