Novo Nordisk, Danish drug maker of several diabetes drugs,
including the once-a-day injectable Victoza
(semaglutide) for diabetes, received FDA approval in December
2017 to market Ozempic (semaglutide), a once-a-week injectable for treating type 2 diabetes. Also known as adult-onset diabetes, type 2 is the most common form of diabetes, and occurs when blood levels of glucose are too high.
In January 2020, Ozempic was also approved "to reduce the risk of major cardiovascular events such
as heart attack, stroke or death in adults with type 2
diabetes mellitus with known heart disease." In December
2020, Novo Nordisk applied with the FDA to gain approval for a
once-weekly 2.4 mg injection of semaglutide for
weight management. In its clinical trial, 85% of
those injected with the T2D drug lost at least 5% of body weight,
and the average participant lost 15% of body weight.
At the time of its approval for diabetes, Ozempic joined at least five other drugs in this relatively new class of diabetes drugs called "incretin mimics" – synthetic versions of hormones released by the intestinal tract ("glucagon-like peptides") that stimulate the secretion of insulin. Also known as GLP-1 receptor agonists, the drug inhibits release of glucose into your blood stream. The resulting effect is the lowering of blood sugar.
The weight loss fringe benefit of the drug (which companies have controversially used as part of their marketing message) is caused by the delay of movement of food from the stomach into the small intestine, suppressing appetite. Not surprisingly, the most common side effects of Ozempic are nausea and/or abdominal pain. The Ozempic drug label reports that more than 20% of clinical trial patients taking the 1 mg dose experienced nausea. Around half of AskaPatient reviewers of drugs in the GLP class (see below) mention this unpleasant side effect. However, many patients report that the nausea diminishes with the passage of time and also with changes to their diets or dosage schedule.
A boxed warning for some of the drugs in this class of GLP-1 drugs highlights an increased risk of thyroid cancer. The labels also warn about pancreatitis risk, kidney injury, and kidney failure. It is important to research the various warnings and treatment options available if you have type 2 diabetes. The GLP-1 drug is meant to be used in conjunction with a diet and exercise program.
GLP-1 Injectable Drugs for Treating Type-2 Diabetes
|Byetta||Amylin||2005||2x a day|
|Rybelsus||Novo Nordisk||2019||1x a day|
*Public Citizen wrote a letter about these drugs and a few others to the FDA's Office of Prescription Drug Promotion in March 2015. The letter pointed out violations in advertising for promoting the drugs "off-label" as a safe and effective weight loss treatment. No actions were taken by the FDA to curtail the promotions.
Results of Novo Nordisk's recent clinical trial were published in February 2021 in the New England Journal of Medicine. In the study, "more participants in the Semaglutide group than in the placebo group achieved weight reductions of 5% or more. " In fact, it found that "the mean change in body weight was -14.9% in the Semaglutide group, as against -2.4% in the placebo group. " GLP-1 Oral Drugs for Treating Type-2 Diabetes. A commentary appearing in the NEJM by deputy editor Julie Ingelfinger, MD, and associate editor Clifford Rosen, MD, noted a lack of diversity among trial participants (most were white women), along with the fact that 40% of study participants were pre-diabetic, “raise additional questions about the efficacy of subcutaneous semaglutide in persons with obesity and normal glucose tolerance.” Also of note is that the weight loss study used a much higher concentration of semaglutide per dose: 2.5 mg per injection vs. a maximum of 1 mg per injection that has been approved for Ozempic's diabetes treatment.
In the second quarter of 2020 FDA report of potential safety risks identified from the FDA Adverse Events Reporting System (FAERS), GLP-1 receptor agonists were flagged for potentially causing hypoglycemia, the FDA is "evaluating the need for regulatory action." In fourth quarter 2019, these drugs were identified as carrying a risk of Diabetic ketoacidosis:
- Adlyxin (lixisenatide)
- Bydureon (exenatide)
- Bydureon BCise (exenatide)
- Byetta (exenatide)
- Ozempic (semaglutide)
- Rybelsus (semaglutide)
- Saxenda (liraglutide)
- Soliqua (insulin glargine and lixisenatide)
- Tanzeum (albiglutide)
- Trulicity (dulaglutide)
- Victoza (liraglutide)
- Xultophy (insulin degludec/liraglutide)
Sources and More information:
Drug Label for Ozempic (includes dosage information for semaglutide)
Potential New Serious Adverse Effect for GLP-1 drugs: FDA Report Second Quarter 2020
June 2021 Update on Wegovy
Novo Nordisk's new weight loss drug
Wegovy was approved in June 2021. It contains the same ingredient as Ozempic, but at higher concentrations. Look up your height and weight in this
BMI conversion table to find out if you are in the grey (overweight) or green (obesity) zone. Patients in the obese or overweight zone with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) are potential candidates for the treatment.
Wegovy is meant to be used as part of a weight management regimen that includes a reduced calorie diet and increased physical activity. Like other drugs containing the synthetic intestinal hormone "Glucagon-like peptide-1" or GLP-1, Wegovy has a boxed warning for the risk of thyroid c-cell tumors. Patients and physicians should carefully consider other warnings, which include risk of pancreatitis, gallbladder disease, and hypoglycemia.
Read the complete
drug label .