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Fda Approves New Fast-acting Mealtime Insulin

Fda Approves New Fast-acting Mealtime Insulin

Officials with the FDA have approved fast-acting insulin aspart (Fiasp, Novo Nordisk) for the treatment of adults with diabetes. Fiasp is a fast-acting mealtime insulin designed for individuals in need of improved overall glucose control. Fiasp, a formulation of insulin aspart, was developed to more closely match the physiological insulin mealtime response of an individual with diabetes. Vitamin B3 (niacinamide) and a naturally occurring amino acid (L-Arginine) were added to increase the speed of absorption and for stability, respectively. The approval is based on clinical trials that demonstrated Fiasp’s clinically relevant improvement in long-term glucose level. The trial researchers noted comparable overall rate of severe or blood sugar confirmed hypoglycemia between Fiasp and aspart. The phase 3 clinical program included 4 trials with more than 2100 individuals with type 1 and type 2 diabetes. According to data presented recently at the 53rd European Association for the Study of Diabetes Annual Meeting, in the onset 1 trial, Fiasp was compared to conventional insulin aspart in type 1 diabetes over a 52-week study, split in two 26-week treatment periods. Over the 52-week period, Fiasp demonstrated a statistically significant greater overall blood sugar reduction of -0.10% adults with type 1 diabetes, in comparison to conventional insulin aspart. Fiasp also demonstrated a statistically significant reduction in 1-hour post-meal sugar increment of -0.91 mmol/L. However, no significant differences were noted in 2-hour post-meal sugar increment compared with conventional insulin aspart. Novo Nordisk received a Complete Response Letter (CRL) from the FDA for Fiasp in October 2016, and later resubmitted the new drug application on March 29, 2017. In this video taken durin Continue reading >>

Novo Nordisk Receives Fda Approval For Fiasp®, A New Fast-acting Mealtime Insulin

Novo Nordisk Receives Fda Approval For Fiasp®, A New Fast-acting Mealtime Insulin

® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.1 Fiasp® can be dosed at the beginning of a meal or within 20 minutes after starting a meal. Fiasp® is a new formulation of NovoLog®, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes.2 Fiasp® will be available in a pre-filled delivery device FlexTouch® pen and a 10 mL vial.1 Many adults with type 1 and type 2 diabetes struggle with blood sugar control after meals. The result of this has led to many people with diabetes not achieving their target A1C. "With Fiasp®, we've built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target," said Bruce Bode, MD FACE, President of Atlanta Diabetes Associates and Associate Professor at Emory University School of Medicine. "The intention of rapid acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management." Fiasp® will launch at the same list price as NovoLog® and will be offered with a Savings Card program for eligible patients with commercial insurance to reduce co-pays. Fiasp® will also be available to eligible patients through the Novo Nordisk Patient Assistance Program. Patients and caregivers can obtain more information and access to the Novo Nordisk Patient Assistance Program by calling toll free at 866-310-7549. The approval of Fiasp® is based on results from the onset phase 3a clinical development program. The clinical trials enrolled more Continue reading >>

New Ultra Fast-acting Insulin Fiasp Is Us Fda Approved

New Ultra Fast-acting Insulin Fiasp Is Us Fda Approved

Novo Nordisk’s Fiasp (insulin aspart) 100 Units/mL has been approved by the US FDA. Fiasp is a fast-acting mealtime insulin for adults with type 1 and type 2 diabetes. According to a PR Newswire press release, it can be given at the beginning of a meal or within 20 minutes after starting a meal. Fiasp is a new formulation of NovoLog. They added niacinamide, otherwise known as vitamin B3 which speeds up the rate of initial absorption. Customers in Europe and Canada have already been using it. How Fast is Insulin Fiasp? The new insulin Fiasp starts working in about 2.5 minutes and will be available by FlexTouch insulin pens or via a 10mL vial. Currently, most fast-acting insulin such as Humalog and NovoLog need 10-15 minutes to begin working and while this doesn’t seem like a big difference, it can be for those who want to begin lowering blood sugar as soon as possible or those who don’t want to wait so long (or at all) before eating for their insulin to kick in. Bruce Bode, MD FACE and President of Atlanta Diabetes Associates and Associate Professor at Emory University School of Medicine said in a statement: “With Fiasp, we’ve built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target,” and that “The intention of rapid acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management.” Fiasp has been FDA approved thanks to results from the onset phase 3a clinical development program. These trials involved over 2,000 adults with type 1 and 2 diabetes. Participants showed a reduction in their A1c levels while taking Fiasp at mealtime and also after starting a meal. Common advers Continue reading >>

Insulin A To Z: A Guide On Different Types Of Insulin

Insulin A To Z: A Guide On Different Types Of Insulin

Elizabeth Blair, A.N.P., at Joslin Diabetes Center, helps break down the different types of insulin and how they work for people with diabetes. Types of Insulin for People with Diabetes Rapid-acting: Usually taken before a meal to cover the blood glucose elevation from eating. This type of insulin is used with longer-acting insulin. Short-acting: Usually taken about 30 minutes before a meal to cover the blood glucose elevation from eating. This type of insulin is used with longer-acting insulin. Intermediate-acting: Covers the blood glucose elevations when rapid-acting insulins stop working. This type of insulin is often combined with rapid- or short-acting insulin and is usually taken twice a day. Long-acting: This type of insulin is often combined, when needed, with rapid- or short-acting insulin. It lowers blood glucose levels when rapid-acting insulins stop working. It is taken once or twice a day. A Guide on Insulin Types for People with Diabetes Type Brand Name Onset (length of time before insulin reaches bloodstream) Peak (time period when insulin is most effective) Duration (how long insulin works for) Rapid-acting Humalog Novolog Apidra 10 - 30 minutes 30 minutes - 3 hours 3 - 5 hours Short-acting Regular (R) 30 minutes - 1 hour 2 - 5 hours Up to 12 hours Intermediate- acting NPH (N) 1.5 - 4 hours 4 - 12 hours Up to 24 hours Long-acting Lantus Levemir 0.8 - 4 hours Minimal peak Up to 24 hours To make an appointment with a Joslin diabetes nurse educator, please call (617) 732-2400. Continue reading >>

A Newer, Faster-acting Insulin? (faster Than Novolog!)

A Newer, Faster-acting Insulin? (faster Than Novolog!)

New findings from phase 3a trials show that a faster-acting insulin aspart by Novo Nordisk reduced A1c levels and improved after meal blood sugars in people with type 1 and 2 diabetes compared with NovoLog. These findings were presented at the 76th annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans. Novolog (also marketed as Novorapid) is a fast-acting insulin aspart. The trial involves 2,100 people with type 1 and 2 diabetes and an even faster-acting insulin aspart. The trial consisted of 26 weeks of randomized therapy using a faster-acting insulin aspart which showed statistically significantly improved A1c in adults with type 1 diabetes when dosed at mealtime compared with Novolog. A similar result in A1c improvement was found when the insulin aspart was dosed 20 minutes after a meal compared with Novolog. What is Faster-Acting Insulin Aspart? Faster-acting insulin aspart is a fast acting bolus or mealtime insulin in investigation stages developed by Novo Nordisk. It is also insulin aspart like Novolog (or Novorapid) but in a new formulation which includes a vitamin and an amino acid intended to increase the initial absorption rate and provide a faster and earlier blood sugar lowering effect. “Novo Nordisk has submitted the regulatory filing for faster-acting insulin aspart in the United States and in the European Union.” How Did the Faster-Acting Insulin Aspart Work in Type 1 Diabetics? The trial also showed a reduction in 2-hour PPG increment versus Novolog. In addition, 1-hour PPG increment was also reduced. The 2-hour PPG increment is the difference between the plasma glucose value at 120 minutes after a standard meal test and the fasting plasma glucose value. The 1-h PPG increment is the difference between the plasma glucose Continue reading >>

Just How Quick Is Fiasp, Novo Nordisk’s Faster-acting Insulin?

Just How Quick Is Fiasp, Novo Nordisk’s Faster-acting Insulin?

Fiasp, a new, faster-acting insulin from Novo Nordisk, is generating a lot of interest and carries with it much potential for improved diabetes care. A sort of acronym for faster acting insulin asparte, Fiasp starts working within two minutes of injection and can even be effective in lowering blood sugar when taken up to 20 minutes after a meal. Existing fast-acting insulin formulations such as Humalog, Apidra and Novo Nordisk’s own NovoLog (called NovoRapid in Europe and Canada), take 10 to 20 minutes to begin lowering blood sugar after injection. According to Novo Nordisk, Fiasp, “has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.” “Our goal in developing Fisap was to try and get closer to mimicking the body’s own insulin response to food,” says Michael Bachner, Associate Director for Product Communications for Novo Nordisk. “Doing that creates a lot of opportunities for how this might be applied to improve care.” Fiasp was approved for use in Europe in January and approved in Canada in late March. Approval in the United States is pending with Novo Nordisk expecting to hear back form the FDA in the fourth quarter of this year, Bachner says. (The FDA application is the Danish pharmacy giant’s second attempt at U.S. approval.) Interest in the new insulin is keen, according to chat boards and as reported by Mike Hoskins for the DiabetesMine team in late April. Tim Street, a diabetes writer, reports an uptick in views to his site since he started reporting on Fiasp. His website diabettech.com—“Where diabetes and technology meet”—says when he started writing about Fiasp visits to his site went from between 200 and 500 per day to between 500 and 1,000 per day. To date, Street has penned six artic Continue reading >>

Types Of Insulin

Types Of Insulin

Insulin analogs are now replacing human insulin in the US. Insulins are categorized by differences in onset, peak, duration, concentration, and route of delivery. Human Insulin and Insulin Analogs are available for insulin replacement therapy. Insulins also are classified by the timing of their action in your body – specifically, how quickly they start to act, when they have a maximal effect and how long they act.Insulin analogs have been developed because human insulins have limitations when injected under the skin. In high concentrations, such as in a vial or cartridge, human (and also animal insulin) clumps together. This clumping causes slow and unpredictable absorption from the subcutaneous tissue and a dose-dependent duration of action (i.e. the larger dose, the longer the effect or duration). In contrast, insulin analogs have a more predictable duration of action. The rapid acting insulin analogs work more quickly, and the long acting insulin analogs last longer and have a more even, “peakless” effect. Background Insulin has been available since 1925. It was initially extracted from beef and pork pancreases. In the early 1980’s, technology became available to produce human insulin synthetically. Synthetic human insulin has replaced beef and pork insulin in the US. And now, insulin analogs are replacing human insulin. Characteristics of Insulin Insulins are categorized by differences in: Onset (how quickly they act) Peak (how long it takes to achieve maximum impact) Duration (how long they last before they wear off) Concentration (Insulins sold in the U.S. have a concentration of 100 units per ml or U100. In other countries, additional concentrations are available. Note: If you purchase insulin abroad, be sure it is U100.) Route of delivery (whether they a Continue reading >>

New Faster-acting Insulin Fiasp Now Available In The Uk

New Faster-acting Insulin Fiasp Now Available In The Uk

A new fast-acting insulin called Fiasp has been launched in the UK for adults with type 1 diabetes or type 2 diabetes. Fiasp received European approval on 10 January this year, and will now be made available to the NHS at no additional cost compared to NovoRapid (insulin aspart). Fiasp, developed by Novo Nordisk, can help improve blood sugar levels after meals by working twice as quickly in the bloodstream following injection. This faster absorption therefore helps people with diabetes achieve lower blood glucose levels after meals. "Today we are very pleased to make available a new and improved mealtime insulin option," said Avideh Nazeri, Director of Clinical, Medical and Regulatory, UK/IRE, Novo Nordisk. "Fast-acting insulin aspart will address the unmet need for those who struggle to keep their blood sugar levels in a healthy range around mealtimes. "This is an important step to help the achievement of optimal mealtime glucose control and ultimately may lead to meaningful health benefits." Clinical trials have shown Fiasp to outperform NovoRapid in helping people with type 1 diabetes achieve better diabetes control after meals and overall. The results were even more pronounced among those using insulin pumps, with no significant increases seen in either hypoglycemia or hyperglycemia. People with type 2 diabetes who took Fiasp also experienced improvements at one hour after eating compared to NovoRapid. "The availability of this fast-acting insulin aspart - that more closely matches a healthy body’s physiological response versus existing treatments - is an incremental improvement in care and may give patients a more effective tool with which to manage their diabetes at mealtimes," added Professor David Russell-Jones, primary investigator for onset 1 (fast-acting in Continue reading >>

Novo Nordisk’s Ultra-fast Rapid-acting Insulin Fiasp Approved In Europe And Canada

Novo Nordisk’s Ultra-fast Rapid-acting Insulin Fiasp Approved In Europe And Canada

Novo Nordisk has announced that their ultra-fast rapid-acting insulin aspart called Fiasp has been approved by the European Commission, covering all 28 European Union member states. According to a GlobeNewswire press release, Fiasp is a new-generation mealtime insulin that works faster and more like the natural physiological insulin response to meals. It has a similar safety profile to Novolog insulin in the US and NovoRapid in the UK and is approved for the treatment of diabetes in adults with type 1 or 2 diabetes as well as for use in insulin pumps. About Ultra-Fast Fiasp Insulin Fiasp is a faster formulation of insulin aspart (Novolog/NovoRapid). It is able to provide “earlier, greater and faster absorption, thereby providing earlier insulin action.” The executive vice president and chief science officer of Novo Nordisk, Mads Krogsgaard said in the press release that, “The incremental benefits with Fiasp® are comparable to those observed for the last generation of mealtime insulins when introduced more than a decade ago.” Krogsgaard is referring to how faster insulin analogs were introduced a little over a decade ago and we saw a great improvement in blood sugar management surrounding meals over the older Regular human insulin. Now it looks like the age of ultra-fast rapid-acting insulin is upon us and bringing another potential improvement in blood sugar management. Fiasp will be available by vial, Penfill, and FlexTouch insulin pen. Effectiveness and Safety of Fiasp EPGOnline reported about the trials conducted comparing Fiasp with insulin aspart (Novolog/NovoRapid). Results from the final Phase IIIa trials called ONSET 1 and ONSET 2 revealed that for people with type 1 diabetes, Fiasp was much more statistically likely to lower HbA1c levels than insulin a Continue reading >>

What Is Rapid Or Fast-acting Insulin?

What Is Rapid Or Fast-acting Insulin?

You may take rapid acting or fast acting insulin (also known as insulin analogues) for your diabetes, either through injections prior to your meals, or in your insulin pump. You may use it alone, or in combination with other insulins and diabetes medications, including injections and pills. In a person without diabetes, the pancreas puts out small amounts of insulin, continuously bringing down blood sugars to a normal level with no difficulty. When a person has diabetes, they may not make any insulin, as occurs in Type 1 Diabetes. They may make some insulin, but it’s not working well, and it’s just not enough to bring blood sugars into a normal range, as occurs in Type 2 Diabetes. When there is no insulin, or not enough insulin, the goal is to try to simulate what the body normally does to bring down blood sugars through injections of insulin, inhaled insulin, or via an insulin pump. To do this, rapid or fast acting insulin must be taken in relation to food that is eaten in many cases. Not everyone with diabetes must take insulin to control their blood sugars, though. Let’s learn how Christie uses rapid acting insulin… Christie’s story Christie has had Type 1 Diabetes for 24 years. She uses a Medtronic insulin pump. Every day, Christie’s pump gives her fast or rapid acting insulin. This is all that insulin pumps need to control blood sugar. For Christie, she uses Humalog lispro insulin. She gets a little bit of this rapid or fast acting insulin continually through her pump via a basal. She also gets some of this insulin through her pump, in a bolus dose every time she eats a meal. In a pump, the same insulin is used all the time, and it is always rapid insulin. Christie also has a new Continuous Glucose Monitor, CGM. She has found with this new technology, s Continue reading >>

Fda Approves Novo Nordisk Fast-acting Insulin Fiasp

Fda Approves Novo Nordisk Fast-acting Insulin Fiasp

(Reuters) - The U.S. Food and Drug Administration on Friday approved Novo Nordisk’s fast-acting insulin to treat diabetes. The product, known as Fiasp, is designed to help diabetics control post-meal spikes in blood sugar. It is already approved in Canada and Europe. Fiasp, or faster acting insulin asparte, is designed to work faster than existing fast-acting insulin such as Eli Lilly and Co’s Humalog and Novo Nordisk’s own NovoLog, known as NovoRapid outside the United States. Last year the FDA declined to approve the product and requested additional information. Continue reading >>

Fast-acting Insulin

Fast-acting Insulin

Even when you think you’re doing everything right with your diabetes care regimen, it can sometimes seem like your blood glucose levels are hard to control. One potential source of difficulty that you may not have thought of is how you time your injections or boluses of rapid-acting insulin with respect to meals. Since the first rapid-acting insulin, insulin lispro (brand name Humalog), came on the market in 1996, most diabetes experts have recommended taking it within 15 minutes of starting a meal (any time between 15 minutes before starting to eat to 15 minutes after starting to eat). This advice is based on the belief that rapid-acting insulin is absorbed quickly and begins lowering blood glucose quickly. However, several years of experience and observation suggest that this advice may not be ideal for everyone who uses rapid-acting insulin. As a result, the advice on when to take it needs updating. Insulin basics The goal of insulin therapy is to match the way that insulin is normally secreted in people without diabetes. Basal insulin. Small amounts of insulin are released by the pancreas 24 hours a day. On average, adults secrete about one unit of insulin per hour regardless of food intake. Bolus insulin. In response to food, larger amounts of insulin are secreted and released in two-phase boluses. The first phase starts within minutes of the first bite of food and lasts about 15 minutes. The second phase of insulin release is more gradual and occurs over the next hour and a half to three hours. The amount of insulin that is released matches the rise in blood glucose from the food that is eaten. In people with normal insulin secretion, insulin production and release is a finely tuned feedback system that maintains blood glucose between about 70 mg/dl and 140 mg/d Continue reading >>

Types Of Insulin For Diabetes Treatment

Types Of Insulin For Diabetes Treatment

Many forms of insulin treat diabetes. They're grouped by how fast they start to work and how long their effects last. The types of insulin include: Rapid-acting Short-acting Intermediate-acting Long-acting Pre-mixed What Type of Insulin Is Best for My Diabetes? Your doctor will work with you to prescribe the type of insulin that's best for you and your diabetes. Making that choice will depend on many things, including: How you respond to insulin. (How long it takes the body to absorb it and how long it remains active varies from person to person.) Lifestyle choices. The type of food you eat, how much alcohol you drink, or how much exercise you get will all affect how your body uses insulin. Your willingness to give yourself multiple injections per day Your age Your goals for managing your blood sugar Afrezza, a rapid-acting inhaled insulin, is FDA-approved for use before meals for both type 1 and type 2 diabetes. The drug peaks in your blood in about 15-20 minutes and it clears your body in 2-3 hours. It must be used along with long-acting insulin in people with type 1 diabetes. The chart below lists the types of injectable insulin with details about onset (the length of time before insulin reaches the bloodstream and begins to lower blood sugar), peak (the time period when it best lowers blood sugar) and duration (how long insulin continues to work). These three things may vary. The final column offers some insight into the "coverage" provided by the different insulin types in relation to mealtime. Type of Insulin & Brand Names Onset Peak Duration Role in Blood Sugar Management Rapid-Acting Lispro (Humalog) 15-30 min. 30-90 min 3-5 hours Rapid-acting insulin covers insulin needs for meals eaten at the same time as the injection. This type of insulin is often used with Continue reading >>

The Fda Just Approved A New Form Of Insulin

The Fda Just Approved A New Form Of Insulin

Judith Garcia, 19, fills a syringe as she prepares to give herself an injection of insulin.AP Photo/Reed Saxon (Reuters) - The Food and Drug Administration on Friday approved Novo Nordisk's fast-acting insulin to treat diabetes. The product, known as Fiasp, is designed to help diabetics control post-meal spikes in blood sugar. It is already approved in Canada and Europe. Fiasp will have the same list price as NovoLog, Novo's own fast-acting insulin that got approved in 2000. Novo said in a news release that it'll be providing savings cards to patients that are eligible to help with co-pays. Fiasp, or faster acting insulin asparte, is designed to work faster than existing fast-acting insulin such as Eli Lilly and Co's Humalog and NovoLog, known as NovoRapid outside the United States. Last year the FDA declined to approve the product and requested additional information. Diabetes is a group of conditions in which the body can't properly regulate blood sugar that affects roughly 30 million people in the US. For many people living with diabetes — including the 1.25 million people in the US who have type-1 diabetes — injecting insulin is part of the daily routine. And the prices of those insulins have been rising — increases that mean some people are spending as much on monthly diabetes-related expenses as their mortgage payment. It's led some people living with diabetes to turn to the black market, crowdfunding pages, and Facebook pages to get access to the life-saving drug. (Reuters reporting by Toni Clarke) Continue reading >>

Fast-acting Insulin, Fiasp, Gets Fda Approval

Fast-acting Insulin, Fiasp, Gets Fda Approval

Recently, the U.S. Food and Drug Administration approved Novo Nordisk’s latest fast-acting insulin, Fiasp, for treatment use by adults with diabetes. The move makes available a product that should allow those with T1D to better meet their target A1C levels by controlling post-meal blood sugar spikes. Fiasp, which is a fast-acting insulin asparte, is designed for dosing at the start of a meal or within 20 minutes of beginning to eat. The insulin registers in the blood stream as quickly as two and a half minutes after application. “Generally individuals are well controlled in long insulin,” said Dr. Todd Hobbs, Novo Nordisk’s Chief Medical Officer for North America. “But being able to hold down and keep the meal excursions from rising is going to have an effect on A1C. When individuals get close to their A1C goals — hit seven or eight — but can’t quite get over the hump, most of the time the barrier is meals.” Fiap grew out of the company’s previous fast-acting insulin product, NovoLog. With Fiasp the company improved the speed of initial insulin absorption rates by adding niacinamide (vitamin B3). “With Fiasp we’ve built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target,” said Dr. Bruce Bode, President of Atlanta Diabetes Associates and an Associate Professor at Emory University School of Medicine. Insulin aspart is a synthetic insulin manufactured from human insulin. A single amino acid is changed in the insulin’s chemical composition to help the insulin be absorbed into the body more quickly. The traditional knock against fast-acting insulin is that’s it’s also fast going, wearing off quickly as well. With Fiasp, Novo Nordisk believes it can continue counteracting tha Continue reading >>

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