Summary :
Novo Nordisk said it had invested 15 years of continuous research to make the oral formulation of semaglutide into a reality.
Novo Nordisk India has launched an oral formulation for an anti-diabetes drug that was available only as injections, and claimed the new drug can help better control blood sugar levels and weight in adults with type-2 diabetes.
Novo Nordisk said it had invested 15 years of continuous research to make the oral formulation of semaglutide into a reality. For this breakthrough, it received the Prix Galien Award in 2020, a prestigious award in the industry. The drug was approved by the Drugs Controller General of India in 2020.
Dr Shashank Joshi, a consultant endocrinologist at Lilavati Hospital, said, “Glucagon-like peptide 1 is a naturally occurring hormone and plays an important role in maintaining the normal level of glucose in the blood. Peptide and protein-based biological medicines are typically very effective, their only drawback being that they are delivered as injectables. This was a barrier to optimal diabetes management, as many people prefer pills over injections.”
Dr. V Mohan, of Dr. Mohan’s Diabetes Specialities Centre in Chennai, said,“People with diabetes and obesity are at an increased risk of Covid-related complications and mortality. The availability of a drug which can improve both blood glucose and body weight will be like hitting two targets with one arrow. Having such a unique molecule will be a boon for people with diabetes, especially during the pandemic.”
The new medication has undergone 10 rigorous Phase 3a clinical trials across several countries including India, the company said. The completed and ongoing global trials with oral semaglutide includes more than 10,000 patients, of which more than 1,000 are from India, said Vikrant Shrotriya, managing director of the pharmaceuticals company.
In India 1 in 12 adults (20-79 years) are living with diabetes. Fifty per cent of people with type-2 diabetes taking three or more oral anti-diabetes drugs do not achieve target blood sugar levels. Moreover, 77 per cent fail to achieve glycaemic goals. Uncontrolled blood sugar, excess weight, and increased cardiovascular risk further contribute to premature death and other diabetes-related complications.
About Semaglutide
Semaglutide, sold under the brand name Ozempic among others, is an antidiabetic medication used for the treatment of type 2 diabetes and long-term weight management. Semaglutide acts like human glucagon-like peptide-1 in that it increases insulin secretion, thereby increasing sugar metabolism
Structure
Why is this medication prescribed?
Semaglutide injection (Ozempic) is used along with a diet and exercise program to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) when other medications did not control the sugar levels well enough. Semaglutide injection (Ozempic) is also used to reduce the risk of a stroke, heart attack, or death in adults who have type 2 diabetes along with heart and blood vessel disease. It is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Semaglutide injection is not used instead of insulin to treat people with diabetes who need insulin. Semaglutide injection (Wegovy) is used along with an individualized low-calorie, low-fat diet and exercise program to help with weight loss in overweight adults who may also have high blood pressure, diabetes, or high cholesterol. Semaglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Semaglutide injection also works by slowing the movement of food through the stomach and may decrease appetite and cause weight loss.
Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
Side Effects
See also Warning section.
Nausea, vomiting, abdominal pain, loss of appetite, diarrhea, or constipation may occur. Nausea usually lessens as you continue to take semaglutide. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (such as decreased/blurred vision).
Semaglutide has rarely caused a very serious (possibly fatal) disease of the pancreas (pancreatitis). Get medical help right away if you develop symptoms of pancreatitis, including: severe stomach/abdominal pain, nausea/vomiting that doesn’t stop.
Although semaglutide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose(s) of your other diabetes medication(s) needs to be lowered. Drinking large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, candy, or drink fruit juice or non-diet soda. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Precautions
See also Warning section.
Before taking semaglutide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain eye problem (diabetic retinopathy), a disease of the pancreas (pancreatitis), kidney problems, stomach/intestinal disorders (such as gastroparesis, digestion problems).
You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.
Limit alcohol while using this medication because it can increase your risk of developing low blood sugar.
It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. The manufacturer recommends stopping use of this medication 2 months before a planned pregnancy.
Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Consult your pharmacist or physician.
Interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are not affected by these drugs.
Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.
About Novo Nordisk
Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, with production facilities in eight countries, and affiliates or offices in 5 countries. Novo Nordisk is controlled by majority shareholder Novo Holdings A/S which holds approximately 25% of its shares and a supermajority (45%) of its voting shares.
Novo Nordisk manufactures and markets pharmaceutical products and services specifically diabetes care medications and devices. Novo Nordisk is also involved with hemostasis management, growth hormone therapy and hormone replacement therapy. The company makes several drugs under various brand names, including Levemir, Tresiba, NovoLog, Novolin R, NovoSeven, NovoEight and Victoza