
Fda Approves Ultra-long-acting Basal Insulin Tresiba – Take It At Any Time Of Day!
Twitter Summary: @US_FDA approves next-gen once-daily basal #insulin Tresiba, plus Xultophy (Victoza + Tresiba) now submitted Novo Nordisk recently announced the FDA approval of the next-generation once-daily basal insulin Tresiba (insulin degludec) and the premixed insulin Ryzodeg (70/30 mixture of insulin degludec and insulin aspart). Tresiba will be launched in early 2016 and will come in prefilled FlexTouch pens. The insulin will launch in two concentrations (U100 or U200), enabling maximum doses of 80 units or 160 units per injection. Exact pricing information is unavailable at this time and we're really hoping that it's priced similarly to Levemir. What makes Tresiba exciting? Several things: Flatter profile: Tresiba lowers blood sugar in a flatter, more predictable way than Levemir or Lantus. Less nighttime hypoglycemia: In certain trials, Tresiba seemed to cause less nighttime hypoglycemia vs. Lantus. This is not exactly “on the label,” but it seems to be true in the "real world” according to doctors with experience with Tresiba. Dosing Flexibility: Tresiba can be taken at any time throughout the day – for example, 8 am on Monday, 12 pm on Tuesday, and 7 am on Wednesday. The insulin lasts for an impressive 42 hours (at least), and doses must be taken at least eight hours apart. This flexibility is a major plus, as all other basal insulins (Levemir, Lantus, Toujeo) must be taken at the same time every day according to the label (though Toujeo gets reports in the real world of also having some further flexibility). Fewer Injections for those using high doses of insulin: Patients can take up to 160 units of Tresiba in a single injection with the U200 pen, which means most patients should be able to take a day’s worth of insulin in a single dose. Toujeo is Continue reading >>

Devote Trial Update: Ultra Long-acting Insulin Tresiba As Safe As Insulin Glargine
DEVOTE trial update: ultra long-acting Insulin Tresiba as safe as insulin glargine During the American Diabetes Associations (ADAs) 77th Scientific Sessions held in San Diego, California, US, a session was given on the DEVOTE clinical trial. DEVOTE was set up to determine the cardiovascular (CV) safety of Novo Nordisks Tresiba (insulin degludec) versus U100 insulin glargine in patients with type 2 diabetes (T2D) at high risk of CV events. Tresiba is ultra-long-acting basal insulin with a duration of action that lasts up to 42 hours, which is better than the 1826 hours provided by currently marketed long-acting insulins such as U100 insulin glargine. During the session, the trial results and implications for primary and secondary endpoints were discussed. While the primary endpoint of the study was time to first CV outcome (CV death, non-fatal myocardial infarction [MI], or non-fatal stroke), secondary endpoints included severe hypoglycemia and severe nocturnal hypoglycemia, glycated hemoglobin (HbA1c), and fasting plasma glucose (FPG). For the primary endpoint, the non-inferiority of Tresiba compared to insulin glargine was observed, confirmed by sensitivity analyses. Results for secondary endpoints revealed significant reductions in both the rate of severe hypoglycemia and severe nocturnal hypoglycemia in the Tresiba group compared to the insulin glargine group, with a 40% and 53% reduction, respectively. Additionally, no significant difference between end of treatment HbA1c between treatment groups was observed, whereas a significant decrease in FPG was observed with the Tresiba treatment compared to the insulin glargine treatment. Although DEVOTE harbored obvious strengths, such as a large global enrollment (7,637 T2D patients) and low dropout rate (approximately 2% Continue reading >>

Know Your Basic Insulin Options
Ginger Vieira was diagnosed with type 1 diabetes when she was 13, celiac disease a year later, and fibromyalgia in 2014. Ginger provides great insights into life with multiple chronic illnesses, including how to make the most of your life despite your health setbacks. Sometimes it's easy to forget that the insulin we're prescribed is not the same as the insulin our bodies make (or don't make, for that matter). These manufactured insulins are great; they help us live longer, healthier lives with diabetes. But they are chemicals, and they are all very different. In fact, some types of insulin work really well for some people and not so well for other people, just as one type of pain reliever might work well for one person but not as well for another person. Our bodies react differently to different chemicals. That's why it's important to know your options and try different insulin regimens with your doctor's help if you're having trouble controlling your blood sugar levels. Here are the basic insulin options available today: Regular: Also known as "Humilin R" or "Novolin R," this is a "short-acting" insulin, also referred to as a “neutral” insulin. According to the American Diabetes Association, it usually reaches the bloodstream within 30 minutes after being injected, and it peaks in effectiveness anywhere from two to three hours after injection. It stays in your body for three to six hours. This older insulin isn't used as widely today because it's considered a "fast-acting" insulin, but isn't nearly as fast as the newer types of insulin. This insulin is often paired with NPH insulin. NPH: This "intermediate-acting" insulin serves as a background or “basal” insulin, and is classified as an “isophane” insulin. The ADA says it "generally reaches the bloodstrea Continue reading >>

Insulin Makers Become Casualties Of Pricing War
Tough competition between diabetes drugmakers, coupled with higher payer leverage, has sparked the question of whether formulary access has become a zero sum game: Does success for one mean failure for another? That is the current climate in the insulin market right now, pushing the leaders in the space to make bold moves. Last month, Danish diabetes drugmaker Novo Nordisk announced its veteran CEO Lars Rebien Sorensen would be stepping down at the end of the year, an expected move but several years ahead of schedule. His successor, Lars Fruergaard Jørgensen, gave some hint to the reasoning behind the leadership change, pointing to "unprecedented" competition and payer pressure. Several weeks later, Novo revealed plans to cut about 2.4% of its global workforce, trimming its R&D and headquarters staff in a move designed with that heightened competitive landscape in mind. Novo Nordisk, along with the French Sanofi and Indianapolis-based Eli Lilly, have long dominated the market for diabetes, and specifically insulin, in the U.S. Yet, a widening range of treatment options and greater leverage on the side of payers, has crimped margins and pitted the three companies in a battle for formulary access. Pricing Pressures Over the past two months, both CVS Health and United Health — two large pharmacy benefit managers — have removed Sanofi’s top-selling basal insulin Lantus (insulin glargine) from their 2017 formulary lists. In place of Lantus, CVS and United Health will give preferred placement to Eli Lilly and Boehringer Ingelheim’s Basaglar (glargine injection), a cheaper, follow-on biologic of Lantus. When Basaglar launches in the U.S. this December, it will be the fifth long-acting insulin on the market, joining Sanofi’s Lantus and Toujeo (glargine) and Novo Nord Continue reading >>

Devote: Insulin Degludec Demonstrates Cv Safety, Reduced Risk For Severe Hypoglycemia
DEVOTE: Insulin degludec demonstrates CV safety, reduced risk for severe hypoglycemia Please provide your email address to receive an email when new articles are posted on this topic. Receive an email when new articles are posted on this topic. SAN DIEGO In the DEVOTE cardiovascular outcomes trial, insulin degludec was noninferior to insulin glargine for the primary endpoint of major adverse cardiovascular events and was associated with significant reductions in severe hypoglycemia among high-risk patients with type 2 diabetes. The randomized, double blind, treat-to-target, event-driven, CV outcomes trial included 7,637 patients with type 2 diabetes enrolled at 436 sites in 20 countries between October 2013 and November 2014. Researchers randomly assigned 3,818 patients to receive insulin degludec 100 U/mL (Tresiba, Novo Nordisk), a new-generation, ultra-long-acting basal insulin, and 3,819 to receive insulin glargine U100 (Lantus, Sanofi), a first-generation insulin, once per day between dinner and bedtime. Complications from cardiovascular disease really remain an unmet challenge and unmet clinical need for patients with type 2 diabetes, Steven P. Marso, MD, chief medical officer for HCA Midwest Health cardiovascular services, said during a press conference at the American Diabetes Association Scientific Sessions. In prior open-label studies, insulin degludec has been linked with lower rates of hypoglycemia and lower day-to-day glucose variability compared with older insulins; however, there is a need for more data on the CV safety of insulin degludec, according to Marso and colleagues. Patients enrolled were at high risk for CV events. At the beginning of the study, 85% had established CVD, chronic kidney disease or both. The mean age at baseline was 65 years, mean Continue reading >>

Are There Any Significant Differences Between Triceba And Toujeo?
medications diabetes injections type-2-diabetes insulin I'm currently taking a long-acting insulin called Triceba. But I recently changed my health insurance, and the new insurance doesn't cover Triceba, it only covers another long-acting insulin called Toujeo. My question is, what are the differences between Triceba and Toujeo? Do they have significant differences in effectiveness, side-effects, and ease of use? Triceba is actually Tresiba. It is a very long-acting basal insulin, that you take once a day. It is probably the best basal insulin today for people who do not have fast-changing basal needs like athletes: very insensitive to when you are taking it. Toujeo is a 3x concentrated version of insulin glargine -- i.e. 3x Lantus. It acts roughly like Lantus, but its increased concentration gives it slightly different properties in terms of timing. The most interesting aspect of Toujeo is that it does not appear to wane "too early" as Lantus often does with many users (Lantus can wane sometimes in as little as 18 or 20 hours for some individuals). This research paper shows more sustaining power for Toujeo vs Lantus. Both Tresiba and Toujeo are modern insulins that are superior in some ways to the old ones. One can be better than the other depending upon your need: if you need A LOT of insulin, then Toujeo is superior to Tresiba, because of its concentration. if you have a significant waning problem with basal insulins, Toujeo would probably be better than any except Tresiba. Tresiba is the ultimate duration-optimized insulin. If you have a waning problem with Toujeo (rare but not impossible), approach your doctor and ask him for a letter of medical necessity, to explain to your insurance that the only insulin you can use really is Tresiba. But there is a good chance Continue reading >>

Compare Tresiba Vs. Lantus
Lowers blood sugar. Tresiba (insulin degludec) is a long-acting insulin you use once a day for all-day sugar control. It can cause low blood sugar, so make sure you can recognize the signs & symptoms and always have a source of sugar handy. Injectable insulins are the most effective medicines for controlling your blood sugar. Tresiba (insulin degludec) is a long-acting insulin that can be taken once daily and at any time during the day. The dose can be adjusted according to your needs. Each pen can deliver up to 160 units per injection. The pens are good for up to 8 weeks at room temperature. Insulin is one of the most effective blood sugar-lowering medication and can lower your A1c (average blood sugar over time) by up to 2-3%. Lantus (insulin glargine) is a long-lasting insulin that provides consistent, all-day sugar control with just once or twice daily dosing. Dose can be easily adjusted to make a customized regimen that's tailored to your body's needs. Lantus (insulin glargine) can be used with liver or kidney problems. Not enough review data. 584 reviews so far Have you used Lantus (insulin glargine)? Leave a review Continue reading >>

Insulin For Type 2 Diabetes
Nothing raises as much fear in the minds of most people with type 2 diabetes as the thought of having to go on insulin. This is a tragedy, because, of all the medications available to diabetics, insulin is the only one capable of not just lowering, but of normalizing, their blood sugar. There are a lot of things about diabetes that should be terrifying: blindness, amputation, kidney failure, impotence, and, worst of all, the very high likelihood of dying, much too young, of a heart attack. All of these are caused by prolonged exposure to high blood sugars. Insulin can prevent all these terrifying things from happening. So why waste your fear on it? Let's look at what it is that people with Type 2 fear about insulin and why these fears are unnecessary. Needles: They Are Painless! It's a shock to many type 2s, but it turns out that the ultra-thin short needles used for injecting insulin under the skin are far less painful than the lancets you use to test your blood. Most of the time they are so painless that you may have to visually check to see if you actually have penetrated the skin, because you can't feel the needle! The key to making injections painless is to equip yourself with a very thin needle, 30 or 31 gauge, and to use the shortest needle compatible with your body size. Many family doctors seem to be unaware that there are newer thinner, shorter needles available for insulin. Mine, for example, had his nurse teach me how to inject with a 1 inch, 28 gauge needle. The needles I ended up using, after doing some web research, was 5/16" 31 gauge which is almost 1/4 of the size of her railroad spike. The second important thing to know about injecting insulin is that when you first start out and are panicking at the idea of giving yourself a shot, it helps to "throw" Continue reading >>
- Relative contribution of type 1 and type 2 diabetes loci to the genetic etiology of adult-onset, non-insulin-requiring autoimmune diabetes
- Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)
- Genetically Engineered Insulin may CAUSE Diabetes Type 1 in Type 2 Diabetics

Tresiba Safer Than Insulin Glargine, Says Novo Nordisk
Diabetics treated with Novo Nordisk's basal insulin Tresiba have a lower risk of developing low blood sugar compared to Sanofi's Lantus, according to a new trial. The SWITCH 2 study found that type 2 diabetics taking Tresiba (insulin degludec) were less likely to have symptoms of low blood sugar (hypoglycaemia) compared to those taking Lantus (insulin glargine), the most-prescribed basal insulin product. Tresiba was as good as Lantus at reducing haemoglobin A1c levels - a marker for glucose control. However, the rate of symptomatic hypoglycaemia was 186 events per 100 patient years for Novo Nordisk's drug, a 30% reduction on the 265 events per 100 patient years seen with insulin glargine. Similarly, nocturnal low blood sugar episodes were reduced 42% with Tresiba compared to Lantus, although there was no significant difference between the two drugs in the rate of severe hypoglycaemic episodes. Hypoglycaemia is one of the biggest concerns for diabetics and, taken together, the results could give Novo Nordisk additional power as it tries to wrest market share away from $7bn-a-year Lantus. Moreover, it could also differentiate Tresiba from biosimilar copies of Sanofi's drug that are starting to reach the market and threaten to disrupt the basal insulin category. Novo Nordisk had been held back in its efforts to compete with Lantus by a delay to US approval of Tresiba, with the FDA rejecting its marketing application for the drug in 2013, although it has been launched in most other major markets. Last October however the Danish drugmaker finally won US approval for Tresiba and combination product Ryzodeg (insulin degludec and insulin aspart), prompting analysts at Sydbank to increase their peak sales predictions for the franchise to around $3bn. In some markets the drug has Continue reading >>
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Novo Hopes Hypoglycaemia Data Will Boost Tresiba
Novo hopes hypoglycaemia data will boost Tresiba Novo Nordisk is applying foran expanded US label for its long-acting insulin Tresiba, hoping to gain an upper hand on Sanofis older rival Lantus. Its data submitted to the FDA shows that compared to its rival, Tresiba caused fewer cases of severe hypoglycaemia, which should be a major benefit to patients, as these low blood sugar episodes are both dangerous and frightening for patients. Data from the DEVOTE study showed that 27% fewer patients in a Tresiba arm experienced an episode of severe hypoglycaemia, resulting in a 40% overall rate reduction of total episodes in patients with type 2 disease. Patients on Tresiba experienced a 53% reduction in the rate of nocturnal severe hypoglycaemia and these differences were all statistically significant. However the DEVOTE trial failed to show that Tresiba is superior to Lantus in terms of cardiovascular outcomes which are increasingly the focus for all diabetes products. Faced with a biosimilar version of Lantus now available in the US and Europe, Novo and its big rival in the insulin market, Sanofi, both need data to justify the premium price of their next generation drugs. Novos Tresiba is competing against Sanofis Toujeo to show superiority to Lantus and Novos older Levemir, but the arrival of a biosimilar is eating into their revenues. The biosimilar, Lilly and Boehringers Basaglar, is around 28% cheaper than Tresiba. However therewas no evidence that Tresiba produced a cardiac benefit compared with Lantus data showed a hazard ratio of 0.91 in favour of Tresibarelative to insulin glargine U100, but with no statistically significant difference between the two treatments. Novo began the DEVOTE trial after a shock rejection by the FDA in 2013 for Tresiba, which required furth Continue reading >>
- I Had Lost All Hopes, Believed That I Would Have To Live With Diabetes All My Life. Now I’m An Ex Diabetic Thanks To This
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- Pharmaceutical giant Novo Nordisk to invest £115m in a new UK drug research centre in post-Brexit 'vote of confidence'

Long-acting Insulins
Rapid-Acting Analogues Short-Acting Insulins Intermediate-Acting Insulins Long-Acting Insulins Combination Insulins Drug UPDATES: TRESIBA ®- insulin degludec injection [Drug information / PDF] Click link for the latest monograph Dosing: Click (+) next to Dosage and Administration section (drug info link) Initial U.S. Approval: 2015 Mechanism of Action: The primary activity of insulin, including TRESIBA, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis. TRESIBA forms multi-hexamers when injected into the subcutaneous tissue resulting in a subcutaneous insulin degludec depot. The protracted time action profile of TRESIBA is predominantly due to delayed absorption of insulin degludec from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of insulin-degludec to circulating albumin. INDICATIONS AND USAGE: TRESIBA is indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use TRESIBA is not recommended for the treatment of diabetic ketoacidosis. Dosing: Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. Rotate injection sites to reduce the risk of lipodystrophy. Do not dilute or mix with any other insulin or solution. Administer subcutaneously once daily at any time of day. Do NOT perform dose conversion when using the TRESIBA U-100 or U-200 FlexTouch pens. The TRESIBA U-100 and U-200 FlexTouch pens dose window shows the number of insulin units to be delivered and NO conversion is needed. HOW SUPPLIE Continue reading >>

Prolonged Exercise And Its Effects On Type 1 Diabetes Mellitus Laurel G. Markert University Of Wyoming, [email protected]
University of Wyoming Wyoming Scholars Repository Honors Theses AY 16/17 Undergraduate Honors Theses Follow this and additional works at: Part of the Endocrine System Diseases Commons This Honors Thesis is brought to you for free and open access by the Undergraduate Honors Theses at Wyoming Scholars Repository. It has been accepted for inclusion in Honors Theses AY 16/17 by an authorized administrator of Wyoming Scholars Repository. For more information, please contact [email protected]. Recommended Citation Markert, Laurel G., "Prolonged Exercise and Its Effects on Type 1 Diabetes Mellitus" (2017). Honors Theses AY 16/17. 25. Prolonged Exercise and Its Effects on Type 1 Diabetes Mellitus Honors Thesis, Spring 2016 Laurel Markert Advisor: Dr. Amy Krist Markert 2 Introduction to Type 1 Diabetes Mellitus Type 1 diabetes mellitus (DM) is presumably caused by an immunological or viral cumulative destruction of the β cells of the pancreas. The β cell eradication leads to a complete or near complete inability to produce endogenous insulin 1, 2. Without insulin, significant amounts of glucose cannot be absorbed by cells and used in metabolic processes. Insulin is a hormone that regulates glucose uptake in skeletal and cardiac muscle cells and adipose tissue by causing insertion of glucose transporter 4 (GLUT4) on cellular membranes. GLUT4 is not stimulated in type 1 diabetes unless synthetic (recombinant) insulin is present. GLUT1 and 3 are not insulin responsive and uptake glucose at a basal rate in red blood cells and neural tissue, respectively. GLUT2 is responsive after meals and uptakes glucose in the liver and pancreas for glycogen storage 55. Type one DM presents with polyuria (frequent urination), ketonuria (ketone bodies in the urine), polydipsia (increased thir Continue reading >>
- Exercise and Glucose Metabolism in Persons with Diabetes Mellitus: Perspectives on the Role for Continuous Glucose Monitoring
- Effects of Insulin Plus Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RAs) in Treating Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis
- Exercise guidelines for gestational diabetes mellitus

Tresiba (insulin Degludec) Vs. Lantus (insulin Glargine)
www.adverahealth.com © 2016 Advera Health Analytics 1 For more information contact us Drug Evidence Review: © Copyright. 2016 Advera Health Analytics, Inc. All rights reserved. This material MAY NOT BE REPRODUCED, DISPLAYED, MODIFIED, DISTRIBUTED or LINKED TO without the express prior written permission of the copyright holder. Advera Health Analytics Inc.’s research may be cited but not excerpted in its entirety. For permission, contact Sharon Miller Actionable Intelligence: Tresiba (insulin degludec), the FDA- approved long-acting injectable insulin analog, seems to have a similar safety profile to its comparator Lantus (insulin glargine), based on their matching labeled serious adverse events (AEs). In head-to-head clinical trials comparing these two insulin analogs, Tresiba (insulin degludec) was statistically non-inferior to Lantus (insulin glargine) in reducing glycosylated hemoglobin levels, fasting glucose levels & confirmed hypoglycemic episodes, but the rate of nocturnal hypoglycemic events were significantly reduced especially in type 2 diabetes patients treated with Tresiba (insulin degludec). Both the drugs had similar rates of serious AEs through the clinical trials. Based on real-world adverse events reported for Lantus (insulin glargine), our analytics have identified: non-labeled Active RxSignals for serious events such as liver transplant, cerebral thrombosis, and myelitis transverse; an RxScore of 43.88; and an RxCost per prescription of $1.62. Drugs Covered: Tresiba (insulin degludec), Lantus (insulin glargine [rDNA origin] injection) Indications Covered: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1 Drug Classes Covered: Insulins and analogues for injection, long- acting MoA Covered: Insulin Receptor Agonists Overview Novo Nordis Continue reading >>

Everything You Should Know About The New Insulins
Although many people can control their diabetes by eating well and exercising, medication is a necessity for others. Fortunately for these folks, there are more options than ever before to help control their blood sugar. And several new insulins have recently been added to the mix: Afrezza, Toujeo, Humalog U-200, Tresiba and Ryzodeg . Here we highlight these new weapons in the diabetes therapy arsenal. Afrezza: Could this be the end of insulin injections? A new insulin delivery system, Afrezza, was just approved by the FDA and is currently available. Afrezza is an inhaled, man-made insulin that is approved for adults with type 1 diabetes (the diabetes in which your own body produces antibodies against your insulin-producing cells) or type 2 diabetes (the type of diabetes where the insulin being produced does not work as it should combined with the body producing less insulin over time). Afrezza is a meal-time insulin taken before eating. This new insulin therapy may be added when your blood sugars can no longer be controlled by pill medication alone or when long-acting insulin injection is not enough to manage your diabetes. It is currently available in a cartridge form which is loaded into a small device. Cartridges come in four, eight and twelve units. Prior to eating, you would inhale the dose of insulin prescribed by your clinician. Long-acting insulin administration is still required if you have type 1 diabetes. Like other FDA-approved insulin products, Afrezza has potential side effects, such as low blood sugar. Also, the dosing is limited to four, eight, or twelve units or a combination of these units: for example, you cannot administer three units or 10 units with this insulin delivery system. Insurance coverage issues as well as possible higher co-pays – and, Continue reading >>

Selected Important Safety Information
Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Tresiba® is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of Tresiba®. Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment Accidental mix-ups betwe Continue reading >>