- Pill May Help People With Type 2 Diabetes Lose Weight, Control Blood Sugar, Early Findings Suggest
- What Makes LuCI Different From Similar Weight Loss Pills
- Possible Health Risks of the Weight Loss Pill
- Who are diet pills suitable for?
- Are weight loss pills safe?
- Where can I buy diet pills safely?
- Orlistat – also known as Alli or Xenical
- Weight loss pills can be suspended
- Fat binding pills
- Carb blockers
- Hoodia gordonii
- Drugs Can Be Used Already, but Should They?
- Top 8 Breakthrough Diabetes Treatments You May Have Missed
- Are You at Risk for Type 2 Diabetes?
- Treatment for Type 2 Diabetes
- 1. Bydureon (exenatide)
- 2. Humalog (insulin lispro)
- 3. Jardiance (empagliflozin)
- 4. Lantus (insulin glargine)
- 5. Soliqua 100/33 (insulin glargine and lixisenatide)
- 6. Toujeo (insulin glargine)
- 7. Trulicity (dulaglutide)
- 8. Victoza (liraglutide)
- See Also
- Further information
- More News Resources
- Diabetes Medicines That Help Your Waistline and Your Heart
- FDA Approval and Known Side Effects
- Does it Work?
- What are the Risks?
Pill May Help People With Type 2 Diabetes Lose Weight, Control Blood Sugar, Early Findings Suggest
Instead of invasive surgery to treat obesity and type 2 diabetes, humans may one day be able to simply take a pill.
That’s what a preliminary study published in June 2018 in the journal Nature Materials suggested, and although the pill has been tested only in rats, the authors are hopeful the medication could be on the market for human use within five years. The compound — which the researchers have dubbed “LuCI,” short for “luminal coating of the intestine”— is designed to be taken orally before a meal. It works by temporarily providing a film over the intestine so only a limited amount of food can be absorbed through the body, potentially aiding weight loss, and helping prevent blood sugar spikes in people with type 2 diabetes.
RELATED: The Weight Loss Plans to Try and the Fad Diets to Skip for Results
What Makes LuCI Different From Similar Weight Loss Pills
It’s not the first time scientists have attempted to create “weight loss surgery in a pill.” More than a decade ago, a pill formerly known as Zetacap, which is not approved by the Food and Drug Administration (FDA), was referred to as the “gastric bypass pill,” ABC News reported, but LuCI stands out because it contains sucralfate, a medication approved by the FDA decades ago to treat ulcers.
Additionally, the surgeons and materials scientists working on LuCI took on a less-common approach to create the pill than has been attempted in previous research, says study author Ali Tavakkoli, MD, bariatric surgeon and codirector of the Center for Weight Management and Metabolic Surgery at Brigham and Women’s Hospital in Boston.
“Our approach is different because we’re targeting the GI tract specifically with a compound that has no systemic absorption and no effects on the liver, brain, pancreas, or other organs involved in glucose or appetite control,” says Dr. Tavakkoli. “It just works locally on the gut,” he added.
The researchers specifically studied how the pill helps control blood sugar levels, but also noted it could help with weight loss in a similar manner to gastric bypass surgery. The surgery alters a patient’s digestive process and how the body absorbs nutrients, and the pill is believed to act in the same way.
Being overweight or obese is one of the biggest risk factors for developing type 2 diabetes, especially for those with body fat concentrated in their stomach (called visceral fat), as opposed to other regions of the body, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Excess fat in this region of the body can lead to chronic inflammation, which may in turn contribute to insulin resistance — the hallmark of type 2 diabetes, the NIDDK notes.
But losing just 5 to 7 percent of your body weight can help stabilize blood sugar levels and help prevent prediabetes from progressing into full-blown type 2 diabetes, according to the Centers for Disease Control and Prevention. Meanwhile, separate research published in December 2017 in the journal The Lancet suggested following a strict, low-calorie diet, which can result in weight loss, may help reverse the full-blown form of the disease.
RELATED: Losing This Much Weight May Help Reverse Type 2 Diabetes, Study Suggests
When researchers administered LuCI to the normal-weight rodents, their response to glucose was lowered by 47 percent within an hour. And a couple of hours later, the effect disappeared. Controlling glucose, or blood sugar levels, is important for cell function and to keep the organs healthy.
Possible Health Risks of the Weight Loss Pill
Other than the fact that the findings from the current study are very early, a concern of creating a pill like this is that it “puts a Band-Aid on the problem, instead of dealing with the root issues of obesity,” says Nancy P. Rahnama, MD, a bariatric physician in private practice in Beverly Hills, California, who was not involved in the research. Additionally, she notes there’s the potential the pill may compromise the absorption of beneficial nutrients.
“There are a lot of consequences with decreasing absorption, such as hypoglycemia,” says Dr. Rahnama. “We need to be able to absorb nutrients — that’s the whole point of food.”
RELATED: 10 Warning Signs of Low Blood Sugar
Hypoglycemia is when a person’s blood sugar is too low. If someone has the condition then takes the pill with a meal, he or she will likely be unable to return blood sugar levels to normal because their intestine has been coated, she explains, noting that the pill doesn’t seem like a long-term, successful plan for controlling diabetes.
Nutrient deficiencies are also a concern for those who undergo bariatric surgery. In particular, iron, calcium, vitamin B12, and vitamin D metabolism are affected, Tavakkoli points out.
But he doesn’t suspect absorption to be significantly compromised with the pill because the bowel coating is only present for a few hours. He suggests patients could potentially take a multivitamin or calcium when there’s no coating of the bowel to provide the supplements they need, “to avoid any kind of intravenous treatment such as iron or (vitamin) B12 shots.”
If successful after larger, more rigorous studies in humans, LuCI may have the potential to provide a much-needed alternative to bariatric surgery, which is not only invasive but also irreversible. The surgery — which an estimated 216,000 people in the United States underwent in 2016 — comes with a long list of other health risks as well, including excessive bleeding, lung problems, and gastrointestinal leaks, according to the Mayo Clinic.
LuCI “could be a therapeutic approach that is safer and associated with significantly less complications, and thus can potentially help a wide patient population,” the authors, who are now testing the pill on rodents that are obese and have type 2 diabetes, conclude in their published paper. If all goes well, they hope to test on humans within the next year or two.
Weight loss pills may hold a world of promise, particularly for people who have tried in vain to find a diet which works for them. Yet slimming pills should be used to support a diet, rather than being relied on for weight loss.
Weight loss pills can be prescribed by your doctor to help combat obesity. Generally, drug’s prescribed by your doctor are more likely to be effective and safer than non-prescription tablets.
If you decide to purchase any slimming pills or herbal supplements , you should let your doctor know.
Who are diet pills suitable for?
Whilst diet pills vary in terms of how they work, the ones available from the NHS and chemists are those that work by blocking the full digestion of the energy from food. Fat binders prevent fat from fully being digested and carb blockers impair the digestion of carbohydrate.
These diet pills therefore may be suitable for people who find it difficult to adequately regulate their diet without the help of the pills. There are those of us who consistently struggle with choosing appropriate portion sizes and others who have psychological reasons for overeating, such as those prone to comfort eating. There may also be other reasons behind a need to consider weight loss pills.
Note that if you have type 2 diabetes, are obese and have struggled to lose weight, you may benefit from certain type 2 diabetes drugs that also facilitate weight loss such as incretin drugs , SGLT-2 inhibitors or alpha-glucosidase inhibitors
Are weight loss pills safe?
For prescribed drugs, research is carried out prior to a medication being approved for use.
Currently, only one weight loss pill, orlistat, is approved specifically for treating obesity on the NHS.
Note that any drug that is powerful enough to help you lose weight is also likely to include side effects that should be considered before taking the treatment. Side effects can range from unpleasant side effects, such as bowel discomfort or nausea, through to very serious side effects, depending on the treatment.
As an example, orlistat, despite being approved for use on the NHS, has been linked with rare cases of liver injury. The safety profile of diet pills that have not been approved is less likely to be known and therefore it is harder to know how much risk these other pills involve. It is advisable not to take risks with diet pills that have not been approved.
Where can I buy diet pills safely?
Every now and again diet pills make the headlines for all the wrong reasons. As a strong example, in April 2015, young student Eloise Parry died after taking diet pills bought from the internet
The example illustrates that buying diet pills from the internet can be a risky business. The safest places for getting diet pills is your doctor or a registered pharmacy.
Orlistat – also known as Alli or Xenical
Orlistat, sold under the trade names Alli and Xenical, inhibits the digestive enzymes that break down fat which prevent it being absorbed by the body.
Approximately a third of the fat you eat will be blocked by orlistat. One orlistat capsule is taken with each meal that contains fat.
Orlistat has been found to be effective when used in conjunction with an appropriate diet , with those who took the pill having more success than those who didn’t. Taking orlistat can therefore help your diet to be more effective.
Orlistat is only prescribed in people with a BMI of at least 28 that have failed to lower their weight through lifestyle changes, such as diet changes and increased physical activity.
Side effects of orlistat include oily and smelly stools, flatulence and frequent needing to go to the toilet. The side effects are related to the fact that undigested fat is being passed out of your body diet, therefore if you lower the fat content of your diet, you will help to relieve the side effects.
The side effects are most prevalent when you first take the pills and tend to reduce over time.
Weight loss pills can be suspended
A number of effective weight loss pills have been suspended from being marketing by the Medicines and Healthcare products Regulatory Agency (MHRA).
Slimming pill sibutramine, marketed as Reductil, was suspended in February 2010 on account of it being linked with an increased risk of heart attacks and strokes
Rimonabant, marketed as Acomplia, was suspended from the marketed as a result of an increased likelihood of psychiatric disorders.
Fat binding pills
Fat binding pills such as Proactol and Lipobind and XLS-Medical Fat Binder, are based on dried cactus extract.
They claim to help to eliminate fat from meals by binding the fat with dietary fibre in the meal. The binded fat-fibre mass is not absorbed by the small intestine and passes out of the body. This means that a proportion of the calories in the fat you eat is not absorbed. The makers claim that unlike with orlistat there are no side effects.
As with orlistat, fat binding pills are likely to be more useful to those who need help with cutting fat content from their diet. As fat binders are yet to be approved for use on the NHS, the effectiveness, health risks and side effects are not as well known as for orlistat.
Carb blockers, such as XLS-Medical Carb Blocker, work by inhibiting the action of the digestive enzyme alpha-amylase which allows some of the carbohydrate from meals to pass through and out of the gut undigested. This means that not all the calories in the carbohydrate you eat will be digested.
Carb blockers may be suitable for people that are struggling to cut down on the amount of carbohydrate they eat. It is advisable not to use carb blockers for prolonged periods of time. Note that the type 2 diabetes drugs Glucobay ( acarbose ) and Glyset (miglitol), which are known as alpha-glucosidase inhibitors drugs, are also carb blockers.
These drugs are available on prescription for people with type 2 diabetes if your doctor agrees that you would benefit from them.
Hoodia gordonii is a South African plant that has been used by bushmen as an appetite suppressant. The Hoodia plant is a protected plant species and harvesting rights have only been granted to a few companies. It’s thought that a number of supplements that claim to contain Hoodia may not.
Of the drugs which do, currently no clinical research is available to back up the claim that it can be used as an appetite suppressant.
Capsiplex is a product based on chilli and capsicum.
The drug claims to be able to speed up your metabolism. The drug saw a great deal of press hype following its introduction in June.
Chili is known to help improve your metabolic rate and as a result Capsiplex, being based on chilli, has similar effects.
As with all so-called fat burning pills, it helps to increase the weight loss results of an effective diet.
Drugs Can Be Used Already, but Should They?
Because the drugs are already on the market, doctors have the ability to prescribe them solely for weight loss.
But experts say such “off-label” use of the drugs can be risky.
“Off-label use happens quite a bit, actually, for obesity drugs because people are so desperate to try something,” says Raj Padwal, MD, an associate professor of internal medicine at the Walter C. Mackenzie Health Sciences Centre in Edmonton, Alberta, Canada.
Large studies testing the drugs for weight loss in people without diabetes are ongoing.
Until the results of those studies are known, “I think the off-label use of these agents would be premature,” Padwal tells WebMD.
He says Byetta and Victoza are already known to be associated with uncommon but potentially serious health risks.
In 2009, the FDA warned doctors about the possibility of kidney problems in patients taking Byetta.
Last June, the FDA sent a letter to doctors reminding them to keep a close eye on patients taking Victoza. In animal studies, the use of Victoza was associated with an increase of certain thyroid cancers. And in clinical trials, people taking the drug had more cases of pancreatitis than people who got other kinds of diabetes medications. “We don’t know the long-term safety, and that is a huge concern,” Spratt says.
Cost is another concern. Without insurance, Padwal says Byetta and Victoza can cost $300 to $500 for a month’s supply. “Given that cost, you kind of want to stick to the indications for the drug, which right now are sugar control in diabetes,” he says.
Top 8 Breakthrough Diabetes Treatments You May Have Missed
Medically reviewed by L. Anderson, PharmD Last updated on Mar 24, 2019.
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Are You at Risk for Type 2 Diabetes?
Diabetes and prediabetes are two of the top pressing health issues in the nation. Recent estimates from the American Diabetes Association (ADA) suggest about 1.5 million Americans are diagnosed with diabetes every year.
Even more concerning is the number of Americans who are at risk for these conditions: it was reported by the Centers for Disease Control and Prevention (CDC) in 2017 that close to 100 million people in the U.S. have diabetes or prediabetes. Prediabetes occurs when the blood sugar levels are higher than normal but not yet high enough to be classified as type 2 diabetes. Weight loss and increased exercise can help prevent a type 2 diabetes diagnosis.
Here are some shocking diabetes statistics according to the most recent data:
- As of 2015, more than 9% of the population, close to 30 million people, had a diagnosis of diabetes.
- The vast majority of those diagnosed with diabetes, about 90% to 95%, have type 2 diabetes.
- Of the 30 million adults with diabetes, over 23 million are diagnosed, and 7.2 million are undiagnosed.
- Another 84.1 million have prediabetes, a condition if left uncontrolled often leads to type 2 diabetes within five years.
- Diabetes remains the 7th leading cause of death in the U.S.
Treatment for Type 2 Diabetes
There’s no cure for type 2 diabetes, but patients may be able to manage their condition by eating healthy, staying active through regular exercise, and maintaining a normal weight. But sometimes this just isn’t enough.
Medication treatment for type 2 diabetes often begins with oral metformin (Glucophage), a drug that is the backbone of oral diabetes treatment regimens. From there, different drug classes may be added to metformin, and for some patients, the use of injectable insulin may be necessary.
Insulin is a hormone the body needs to utilize the glucose (sugar) from food to provide energy for the body. In type 1 diabetes, the pancreas makes no insulin and it must be replaced. In type 2 diabetes, either the pancreas either doesn’t make enough insulin, there is resistance to the effects of insulin, or both.
Diabetes treatments are monitored using a blood sugar target called hemoglobin A1C (HbA1c) that gives average blood glucose levels over the past 3 months.
For adults, the American Diabetes Association (ADA) recommends a target HbA1C of below 7%; however, in March 2018, the American College of Physicians (ACP) issued new guidance, suggesting targets between 7% and 8%. Part of the ACP reasoning is to adhere to a more individualized approach to type 2 diabetes treatment. For example, in the elderly, very low blood sugars can be linked with serious health issues, including confusion and fainting.
High blood sugar levels can increase the risk for serious complications due to diabetes such as:
- vision loss
- peripheral nerve damage
- kidney impairment
- hard-to-treat infections
- heart disease.
However, the latest diabetes news is encouraging. Newer drugs with a positive outcome on heart disease and death, improved monitoring devices and an understanding of how diet and exercise impact diabetes is adding up to a gain in outcomes for patients. The vast majority of people with type 2 diabetes are living longer lives due to better medications, and a better understanding of the disease and the numerous complications that result from this chronic disease.
In response to the type 2 diabetes epidemic, the U.S. Food and Drug Administration (FDA) continues to approve and improve type 2 diabetes medications and ease dosing regimens for patients.
Here is a selection of some top type 2 diabetes treatments and their latest breakthroughs:
1. Bydureon (exenatide)
Originally approved in 2012, AstraZeneca’s Bydureon (exenatide extended-release) was the very first once-weekly treatment approved for type 2 diabetes. Bydureon is a long-acting form of exenatide, the same active ingredient found in Byetta, but Byetta is given twice-a-day instead of once-a-week.
The 2 mg Bydureon injection is used with diet and exercise in people on one or more type 2 diabetes medicines to improve blood sugar control. Bydureon is a glucagon-like peptide 1 (GLP-1) agonist, or incretin mimetic, that binds to GLP-1 receptors to help the pancreas produce more insulin in response to an increase in blood sugar.
In October 2017, the FDA also approved once-weekly Bydureon BCise (exenatide) in a single-dose autoinjector device for adults with type-2 diabetes. Bydureon BCise consists of a novel, continuous-release microsphere delivery system that is designed to provide consistent therapeutic levels of exenatide.
In April 2018, the FDA approved Bydureon as an add-on to basal insulin in adults who need extra blood sugar control. In the 28-week DURATION-7 study, Bydureon or placebo were evaluated as add-on therapy to insulin glargine, with or without metformin, in adults with type 2 diabetes. Blood sugar control, as measured by the HbA1c, was reduced by 0.9% in the Bydureon group compared to 0.2% in the placebo group. Over 32% of patients in the Bydureon group reached an HbA1c of <7.0% compared to 7% of patients in the placebo group.
Low blood sugar (hypoglycemia) can be a problematic side effect when Bydureon is used with insulin. The dose of insulin when combined with Bydureon may need to be reduced. Symptoms of low blood sugar include a headache, sweating, shaking, anxiety, fast heartbeat, irritability, rapid breathing, or a confused state. Patients should learn to recognize these effects so they can treat low blood sugar with a carbohydrate source.
Other common side effects with Bydureon have included:
- injection site itching
- injection site nodules.
As with other GLP-1 agonists, Bydureon labeling contains a warning about the increased risk of thyroid cancer, as seen with animal studies; however, the risk in humans is not known.
2. Humalog (insulin lispro)
Insulin is a hormone that works to lower levels of blood glucose (blood sugar) and is found either naturally in the body or man-made and given by injection or inhalation. The development of life-saving insulin for people with diabetes is one of the top medical breakthroughs in the history of medicine.
Humalog (insulin lispro), from Eli Lilly is one of several man-made insulins for patients with diabetes. Humalog is known as a “fast-acting” insulin that starts to work about 15 minutes after injection, effects peaks at one hour, and it keeps working for 2 to 4 hours. It is typically given within fifteen minutes before a meal or immediately after a meal and may be used in regimens with an intermediate- or long-acting insulin for insulin coverage throughout the day.
Humalog is used to improve blood sugar control in both type 1 diabetics, who do not produce insulin from the pancreas, and type 2 diabetics, who still produce insulin (but it’s not used efficiently). As blood sugar levels rise with meals, those with diabetes may need insulin injections at mealtime if their blood sugar is not controlled with other diabetes medications.
Hypoglycemia (low blood sugar) is the most common side effect with insulins, including Humalog. Always have a quick source of some type of sugar available for hypoglycemia episodes, for example:
- jelly beans
- glucose tablets
- fruit juice.
The Humalog Junior KwikPen (100 units per mL) is also available for children as a prefilled 3 mL disposable pen with half-unit dosing. Each turn of the dose knob dials 0.5 (½) unit of insulin. You can give from 0.5 (½) to 30 units in a single injection.The maximum dose per injection is 30 units.
In December 2017, the FDA approved Admelog (insulin lispro), the first rapid-acting insulin approved as a “follow-on” (or biosimilar-type product) to Humalog. Costs with Admelog may be lower than other insulin lispro products.
3. Jardiance (empagliflozin)
Death from heart disease is 70% higher in diabetics compared to those without diabetes. So controlling heart (cardiovascular) disease in patients with type 2 diabetes in an important goal.
Jardiance (empagliflozin), from Boehringer Ingelheim and Eli Lilly, is classified as a sodium glucose co-transporter-2 (SGLT2) inhibitor and was originally approved in 2014 to improve blood sugar control (HbA1c) in adults with type 2 diabetes alongside diet and exercise.
In 2016 the FDA approved a new indication for Jardiance: to lower the risk of cardiovascular death in adult patients with type 2 diabetes and heart disease.
For the new indication, Jardiance was studied in a Phase 4 (post-marketing) study of more than 7,000 patients, and was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies.
Jardiance side effects may include:
- dehydration and low blood pressure that can result in dizziness and fainting
- yeast infections
- low blood sugar with insulin or insulin secretagogues
- elevation in LDL cholesterol
- increased risk for urinary tract infections
- impaired kidney function.
For a full description of side effects with Jardiance visit this section.
4. Lantus (insulin glargine)
While short-acting insulins like Humalog are used at mealtimes, long-acting basal insulins work to keep the blood sugar levels even throughout the day. Lantus (insulin glargine), from Sanofi, is used to treat adults with type 2 diabetes and adults and children 6 years and older with type 1 diabetes.
Lantus provides a slow, steady release of insulin and helps to manage the blood sugar levels between meals and overnight.
- The onset of Lantus is usually within 1 to 3 hours, with a duration of 24 hours.
- Due to its long duration of action it is injected subcutaneously (under the skin) just once a day, at the same time each day.
Some patients use a rapid acting human insulin or an oral diabetes medication in combination with Lantus.
- Lantus comes as a 100 units/mL in either 10 mL vials or as the 3 mL SoloStar prefilled pen.
- With the SoloStar pen, you dial the dose you need on the pen and use the push button for injection.
5. Soliqua 100/33 (insulin glargine and lixisenatide)
In November 2016, the FDA approved Sanofi’s Soliqua 100/33 injection (insulin glargine and lixisenatide), a combination of insulin glargine 100 Units/mL and lixisenatide 33 mcg/mL, a glucagon-like peptide-1 (GLP-1) agonist. The two drugs combined now mean one injection for the patient with type 2 diabetes, instead of two. That’s a big improvement.
Soliqua 100/33 combines a long-acting, basal insulin with a GLP-1 (glucagon-like peptide-1) receptor agonist to help control blood sugar and lower HbA1c. It is used with diet and exercise to control blood sugar in adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide. It comes as a single dose, pre-filled pen and is given as a once-daily injection.
- Lantus is a long-acting basal insulin that provides a steady insulin release to manage blood sugar levels between meals and at bedtime.
- Adlyxin is a GLP-1 agonist that helps the pancreas produce more insulin in response to an increase in blood sugar and controls glucose production from the liver.
In studies, Soliqua 100/33 showed better HbA1c lowering (average blood sugar over time) versus Lantus with 55% of patients achieving a target of less than 7% at 30 weeks, compared to 30% with Lantus alone. Hypoglycemia rates were similar in both groups.
The most common side effects with Soliqua include low blood sugar, nausea, diarrhea, respiratory tract infections, and headache.
6. Toujeo (insulin glargine)
Long-acting insulin injections help patients with diabetes control their blood sugar levels over a 24-hour period. In March 2015, the FDA approved Sanofi’s Toujeo (insulin glargine), the same active ingredient that’s in Lantus. Toujeo is a once-daily, long-acting basal insulin for adults with type 1 or type 2 diabetes.
In the clinical trials evaluating Toujeo, all of the primary study endpoints were met by demonstrating similar blood sugar control with Toujeo as compared to Lantus. Toujeo’s onset is within 6 hours, and it has a duration of up to 36 hours, reaching a steady blood level by about day five.
The most common side effects reported for Toujeo (excluding low blood sugar) included the common cold and upper respiratory tract infections.
The Toujeo SoloStar pen can make life easier for patients with type 2 diabetes, possibly lowering the number of injections per day as well as the number of pens used those who need higher insulin doses.
Toujeo is available in 2 disposable prefilled pens:
- Toujeo SoloStar contains 450 units of Toujeo U-300. It delivers doses in 1 unit increments and can deliver up to 80 units in a single injection.
- Toujeo Max SoloStar, approved in March 2018, contains 900 units of Toujeo U-300, more insulin than any other long-acting insulin pen. It delivers doses in 2 unit increments and can deliver up to 160 units in a single injection. It is recommended for patients requiring at least 20 units per day.
7. Trulicity (dulaglutide)
Trulicity (dulaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.
In Sept. 2014, Trulicity, from Eli Lilly, was FDA-approved as a once-weekly subcutaneous (under the skin) injection used to improve blood sugar levels, along with diet and exercise, in adults with type 2 diabetes. Trulicity is not recommended as the first choice of medicine for treating type 2 diabetes, but may be added to other oral agents.
In six pivotal clinical trials, 3,342 patients with type 2 diabetes received Trulicity. Patients had an improvement in their blood sugar control as observed with reductions in HbA1c level (a measure of blood sugar control). A modest amount of weight loss may also occur with Trulicity use. It might be a good option in overweight type 2 diabetic patients who gain weight taking oral medication, it promotes weight loss by suppressing appetite. As a class GLP-1 receptor agonists are associated with weight loss, which is advantageous in a person with type 2 diabetes.
The dose of Trulicity is 0.75 mg injected subcutaneously (under the skin) once a week. The dose may be increased to 1.5 mg once weekly if needed. Trulicity comes as a pen device with an automatic injector. Once-weekly dosing may be a big advantage for many patients.
Another advantage to GLP-1 receptor agonists is a low risk for low blood sugar (hypoglycemia), especially compared to insulin or sulfonylureas. But if Trulicity is used in combination with these medicines, the risk for low blood sugar may rise; lower doses of these medications may be needed if combined with Trulicity.
GLP-1 receptor agonists, like Trulicity or Victoza, should not be used by anyone with a personal or family history of certain types of thyroid cancer. A boxed warning exists for all GLP-1 receptor agonists (Trulicity, Victoza) for possible thyroid tumors, including cancer.
In studies, only animals developed thyroid tumors; human risk is not known. However, do not use Trulicity if you have a personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. Speak to your doctor about these thyroid warnings.
Common side effects with Trulicity include:
- stomach pain
- decreased appetite.
8. Victoza (liraglutide)
Victoza (liraglutide) from Novo Nordisk is also a glucagon-like peptide-1 (GLP-1) receptor agonist (incretin mimetic) indicated to improve glycemic control in adults with type 2 diabetes mellitus. It is in the same class of drug as Trulicity.
Type 2 diabetes patients have a four times greater risk of developing heart disease, which is the leading cause of disease and death in patients with type 2 diabetes.
Although Victoza was originally approved in January, 2010, in 2017 it gained a new labeled indication to reduce the risk of heart attack, stroke and cardiovascular (CV) death in adults with type 2 diabetes and established heart (cardiovascular) disease. Currently, it is the only GLP-1 receptor agonist with data in its label to show a cardiovascular risk reduction.
Victoza demonstrated a life-saving benefit that included a 22% reduction in cardiovascular death and a 15% reduction in all-cause death.
In the landmark LEADER study, 9,340 type 2 diabetes patients with heart disease were randomized to Victoza 1.8 mg or placebo for a median duration of 3.5 years. Researchers found that the addition of Victoza to standard care in these patients significantly reduced the risk of a 3-part, composite, primary endpoint, consisting of:
- death due to heart disease
- nonfatal heart attack
- nonfatal stroke.
Other endpoints that were met included reduction in cardiovascular death, and death from any cause.
Victoza did not reduce the individual rates of heart attack, nonfatal stroke, or hospitalization for heart failure.
The most common side effects leading to the study discontinuation of Victoza were gastrointestinal (stomach) events, which are common with GLP-1 receptor agonists. The most common side effects of Victoza are headache, nausea and diarrhea.
Victoza is available as 0.6 mg (for initial titration), 1.2 mg or 1.8 mg injection in pre-filled, multi-dose pens. Each 3 mL pen contains 6 mg/mL of liraglutide. Victoza is used once daily each day, and it can be used at any time of the day.
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A new diabetes drug that lowers blood sugar and also helps people lose weight has been approved by the U.S. Food and Drug Administration.
The once-a-week injection drug Ozempic (semaglutide) is approved for people with type 2 diabetes. It stimulates the body’s insulin production and reduces appetite, the Associated Press reported.
The drug is from Danish company Novo Nordisk. A company-funded study of 1,200 type 2 diabetes patients found those who took Ozempic had average reductions in long-term blood sugar levels at least 2.5 times greater than those who took the daily diabetes pill Januvia.
Patients who took Ozempic also lost two to three times as much weight as those in the comparison group, the AP reported.
Many people with type 2 diabetes are overweight or obese. Substantial weight loss can help lower their blood sugar and better control their diabetes.
Novo Nordisk is also assessing Ozempic separately for weight loss alone.
Ozempic costs $676 for a four- to six-week supply without insurance. Novo Nordisk also markets a similar once-a-day shot, Victoza, the AP reported.
Diabetes Medicines That Help Your Waistline and Your Heart
By Daniel Einhorn on March 13, 2019 / GLP1-RAs, Medications, SGLT-2 Inhibitors, Type 2, Type 2 Glucose Control
Among the dirty little secrets of the older diabetes medicines was that they usually made you gain weight, they could cause low blood sugar suddenly and unexpectedly, and they had no particular benefit to the most important consequence of type 2 diabetes (T2D) – heart disease.
All that changed with the release of two newer classes of diabetes medicines. The first are called GLP1-RA’s (to be explained, below) which include brand names Byetta, Victoza, Bydureon-BCise, Trulicity, and Ozempic. The second are SGLT2i’s (ignore that too, for now) named Invokana, Jardiance, Farxiga, and Steglatro. Whew – that’s a lot of names and choices. And there’s more to come! That’s what happens when you have a good thing going.
Here are some of the good things they do:
- They don’t cause low blood sugar by themselves.
- Although the details of research studies are always nuanced, and different drugs have different levels of study outcomes, in general the evidence is very strong that these medicines significantly decrease risk of death from all causes, heart attacks, sudden death, and stroke. SGLT2’s also prevent hospitalization for heart failure. Guidelines from diabetes and heart disease societies name these meds specifically as first choices to treat people with T2D who have established cardiovascular disease (CVD). Since there is no official definition of “established CVD”, it can be argued that all adults with T2D should be treated with SGLT2 inhibitors and/or GLP1-RA’s.
- These medicines also lower body weight by 3-7%, and the weight stays off for many years of follow-up. The weight lost is mainly from fat, not fluid or muscle, though there is always some of that too. The amount of weight loss varies widely, and while these are specifically not supposed to be weight drugs, this percentage of weight loss is significant for metabolic health.
- The medicines lower systolic blood pressure by about 5 mmHg, which is about as much as most blood pressure agents. Systolic is the higher number on blood pressure. Lowering blood pressure is one of the most important ways to prevent CVD and especially stroke.
- While the definitive studies are soon to be released, it appears these drugs prevent the usual decline of kidney function with age, which everybody has but which people with T2D have twice as fast. Preventing chronic kidney disease (CKD) may be the most significant contribution since it greatly increases risk for CVD and is among the biggest drains on the U.S. healthcare budget.
While the old, inexpensive generic drug metformin is still typically used first for T2D, many argue the benefits of GLP1-RA’s and SGLT2 inhibitors are more than worth the money and that they ultimately save money. I still support metformin because of many other virtues that it has, but would argue against using sulfonylureas because of risk of hypoglycemia and weight gain, and maybe even worsening risk for CVD. Too bad today’s insurance goes for cheapest in the short term instead of the most value in the long term. Regardless, most people with T2D will eventually require combinations of these meds anyway.
So How Do They Work?
Well this is cool too, and they are very different.
GLP1-RA’s are “glucagon-like peptide receptor agonists” because native GLP1 physically resembles glucagon even though its actions are almost opposite. GLP1 is co-secreted with insulin in normal physiology and in many ways has actions that are complementary to insulin. It enhances the actual secretion of insulin in proportion to glucose, inhibits levels of the actual hormone glucagon (which would raise glucose), slows the otherwise faster stomach emptying of T2D, and, remarkably, signals the brain when you’ve had enough food, so most people eat less and lose weight. GLP1-RA’s act like GLP1.
GLP1-RA’s have to be injected, like insulin, but they still are really easy to live with because they can be taken anytime daily (Victoza) or weekly (Bydureon-BCise, Trulicity, and Ozempic), come in easy dose pens, and have needles so small you can hardly feel them if you don’t use alcohol to prep the skin. Byetta has to be used twice daily and timed before meals, so although it was the original GLP1-RA from San Diego-based Amylin Pharmaceuticals, it is used less often today. An oral GLP1-RA has been developed and is in the later stages of review by the FDA.
SGLT2 inhibitors are once-daily tablets that cause the kidneys to release glucose into the urine, generally 65 to 100 grams daily (100 grams is roughly 400 calories, if you wondered). The kidneys have a system to absorb glucose from the urine called the “sodium-glucose-luminal-contransporters 1 and 2”, and SGLT21’s inhibit that absorption. You would think that losing 400 calories per day would reduce a person to dust in no time, but the body has many compensatory mechanisms so the weight eventually plateaus and some people, somehow, don’t lose much weight while others lose 10-15 lbs.
What Are the Side Effects?
As you might guess from the way they work, people taking SGLT2i’s pee more urine at first, and so should increase water intake by about a quart daily for the first week or so. After that it tends to return to a normal steady state. And because the urine is full of sugar, you have to be careful with good hygiene around urination, especially for women, to avoid yeast infections. If yeast infections do happen, it’s rarely more than once and is easily treatable with over-the-counter remedies for three days (not one, because of diabetes itself).
The GLP1-RA’s have to be started at low dose and built up slowly over a few weeks to minimize gastrointestinal side effects like nausea or diarrhea. Once stable, those side effects don’t occur.
Every person is unique, however, so one always needs to be cautious with any new medication.
Good News for Those with Type 1 Diabetes?
Although not approved for use in people with type 1, there is very promising research that has been done showing benefits of both classes of agents, especially the SGLT2i’s, to smooth out glucose variability, especially around meals, and to somewhat decrease insulin requirements. We are still working out the safety issues and the best strategies for introducing these agents to avoid diabetic ketoacidosis, but I anticipate their use in type 1 soon.
Good News for People Who Don’t Have Diabetes?
Perhaps. SGLT2i’s are being tested for those at risk for congestive heart failure, in particular, and both classes for heart and kidney preservation as well. We should know more in a few years, but stay tuned. There is an enormous amount of research interest in these meds and in the lessons they are teaching about human physiology.
If these agents are so good, why isn’t everyone on them and why do we still have so much poor diabetes control and diabetes complications? It’s beyond the scope of this piece to tackle that, but we need to do it as a community and as a nation. Dr. Edelman and Dr. Polonsky have contributed important work in this area, and the ADA has held consensus conferences to address this gap between possibility and reality. But knowledge is power, and now you have more knowledge about these exciting medications. And always remember that good nutrition, keeping fit, sleeping well, maintaining purpose, reveling in humor, and embracing friends and loved ones remain the mainstays of any plan to be healthy.
Alli is the first FDA-approved over-the-counter weight loss pill. Made by GlaxoSmithKline, Alli is a half-dose version of the prescription drug Xenical. Orlistat, the active ingredient in both Xenical and Alli, inhibits the absorption of certain fats in the intestine. The subsequent excretion of these unabsorbed fats helps patients lose weight. While Xenical is sold in 120 mg doses and usually taken 3 times per day, Alli pills are 60 mg each and are taken 3 times daily with each fat-containing meal.
For the drug to be fully effective, the “myAlliplan” recommends starting a diet prior to taking Alli. The plan specifies that the drug is to be used only in conjunction with a weight loss program that includes a reduced calorie diet, a low fat diet, and an exercise program.
FDA Approval and Known Side Effects
Alli is approved for overweight or obese adults over 18 years of age and is not intended for people who have problems absorbing food or for those who are not overweight. If someone is taking blood thinning medications or is being treated for diabetes or thyroid disease, physician consultation is recommended.
The most common side effects of orlistat include “oily spotting, loose stools, more frequent stools that may be hard to control,” and flatulence. Suggestions provided by GlaxoSmithKline’s myalli.com Web site include wearing dark pants and remaining near a bathroom. The Web site also suggests strictly following the low-fat, low-calorie diet and regular exercise recommended for Alli users in order to minimize such side effects. By consuming fewer calories and burning more fat through exercise, overall fat levels in the body drop and therefore less fat passes through the digestive system.
Does it Work?
The side effects are much worse if a patient eats fats in their diet, so people taking orlistat will be highly motivated to eat a low-fat diet. Perhaps for this reason, clinical trials indicate that orlistat users are more likely to lose at least 5% of their baseline weight compared to other dieters, and although they often gain the weight back they keep off more weight compared to other dieters. Diabetics who take orlistat have lower blood sugar levels and blood pressure than other diabetics, but their weight loss is modest. Some experts question whether the benefits outweigh the side effects and risks: for example, in one recent study, the orlistat + diet and exercise group went from 242 lbs to 229 lbs and the placebo + diet and exercise group went from 242 lbs to 235 lbs. These are modest weight losses, and the orlistat dosage in that study was twice as high as Alli’s.
Alli blocks about 25 percent of the fat a person consumes from being absorbed by the intestine so that the excess fat passes through the system. The absorption of fat-soluble minerals and vitamins such as E, A, D, and K is also partially inhibited, but patients in clinical trials did not suffer from vitamin deficiency if they consumed vitamin supplements concurrently with orlistat.
What are the Risks?
Other than the previously mentioned gastrointestinal side effects and loss of vitamins, there are concerns that orlistat may cause colon and breast cancer. Public Citizen Health Research Group raised these concerns to the FDA in a citizen petition demanding the removal of Xenical from the market and the denial of approval for Alli. They pointed out that previous studies found a significant increase in breast cancer among orlistat users, and evidence that these drugs cause a significant increase in aberrant crypt foci, which research indicates could be a “precursor of color cancer.” In their response to the petition, the FDA did not deny that there were unanswered questions about long-term safety, but indicated that the evidence was not sufficient to justify rescinding approval. The FDA maintains that orlistat is safe and effective. However, the lack of long-term data raises questions about long-term safety.
In summary, Alli can help people stick to their diets, because cheating can cause very unpleasant gastro-intestinal side effects. As a result, Alli + diet + exercise seem to be more effective than diet + exercise alone. However, most people who take Alli or Xenical do not lose 5% of their weight or more (10 pounds for someone starting at 200 pounds), many of those taking the drug may need to stay close to a bathroom to avoid embarrassment, and the drug could potentially increase the risk of breast cancer or colon cancer in the long-term.
All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.
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