Ada: New Insulin As Effective As Lantus
SAN FRANCISCO -- A new insulin glargine product proved to be noninferior to the top-selling Lantus in patients with type 1 and type 2 diabetes, researchers reported here. The new insulin glargine (LY2963016) being developed by Eli Lilly and Boehringer Ingelheim showed similar reductions in HbA1c and hypoglycemia as Lantus in both types of diabetes patients, researchers reported here in three oral presentations of data from the ELEMENT series of trials. The new insulin contains the same amino acid chain as Lantus, which has led to complexity in the way the drug will be regulated in the U.S. Julio Rosenstock, MD, of Dallas Diabetes & Endocrine Center, who presented data on type 2 diabetics, began his presentation with an explanation of the gray area into which the drug falls. Since insulin glargine was approved via a New Drug Application (NDA) with the FDA, the new form of insulin glargine will follow the same pathway in the U.S., even though many consider it to be a "biosimilar" version of insulin. "In my book, it is a biosimilar," Rosenstock said, adding that in other countries it will likely be approved and regulated as a biosimilar. It will not be considered generic. 'Biosimilar' Insulin Holds Up The ELEMENT 2 Study enrolled about 700 patients with type 2 diabetes who were taking other oral antidiabetic drugs to assess whether LY2963016 was noninferior to Lantus. They found over the 24-week study period that both drugs produced similar changes in HbA1c, with a mean reduction of about 1.3% in both groups. About the same proportion of patients in both groups achieved an HbA1c of 7% or less: 53% of those on Lantus and 49% of those on the new insulin glargine. There were similar reductions in fasting plasma glucose and changes in body weight, as well as similar rates of b Continue reading >>
Ada: Once-daily Dosing With Lantus And Levemir Similar For Type 2 Diabetes But Different For Type 1
WASHINGTON, June 13 — Long-acting insulin analogs Levemir (insulin detemir) and Lantus (insulin glargine) appear equal for once-daily use in type 2 diabetes, yet Lantus may have an edge for type 1 diabetes. The two head-to-head comparisons of the metabolism activity of the long-acting insulins, presented at the American Diabetes Association meeting here, are virtually the first reports of their kind for these drugs. Both agents are FDA-approved. "We do not have any pharmacodynamic studies in type 2 diabetes for either insulin," said Tim Heise, M.D., CEO of clinical science at Profil Institute for Metabolic Research in Neuss, Germany, "and up to this conference we had no direct comparison between these two long-acting agents at all." In an oral presentation, Dr. Heise reported the results of a study that randomized 13 patients with type 2 diabetes to Levemir and 14 to receive Lantus. Both agents were given at 0.4, 0.8, and 1.4 U/kg doses to "cover the dose range" used by clinicians, with periodic 24-hour glucose monitoring under glucose clamp conditions. "There is no difference in the time-action profiles between glargine and detemir with regard to the duration of action and mean metabolic impact," he said. The groups had similar baseline characteristics with an average body mass index (BMI) of about 30 kg/m and an HbA1c of about 7.6%. The researchers included only patients with fasting C-peptide levels below 1 nmol/L to eliminate endogenous insulin production as a confounding factor. Also, all participants were male, which Dr. Heise said was to control for the differences in glucose metabolism that occur during the menstrual cycle. The researchers found that "there is really no difference" in glucose infusion rates between the Lantus and Levemir. The only differe Continue reading >>
Levemir Vs. Lantus: Similarities And Differences
Levemir and Lantus are both long-acting injectable insulins that can be used for long-term management of diabetes. Insulin is a hormone that is naturally produced in the body by the pancreas. It helps convert the glucose (sugar) in your bloodstream into energy. This energy is then distributed to cells throughout your body. With diabetes, your pancreas produces little or no insulin or your body is unable to use the insulin correctly. Without insulin, your body can’t use the sugars in your blood and can become starved for energy. The excess sugar in your blood can also damage different parts of your body, including your blood vessels and kidneys. Everyone with type 1 diabetes and many people with type 2 diabetes must use insulin to maintain healthy blood sugar levels. Levemir is a solution of insulin detemir, and Lantus is a solution of insulin glargine. Both are basal insulin formulas. That means that they work slowly to lower your blood sugar levels. They’re both absorbed into your body over a 24-hour period. They keep blood sugar levels lowered for longer than short-acting insulins do. Although the formulations are slightly different, Levemir and Lantus are very similar drugs. There are only a few differences between them. Children and adults can use both Levemir and Lantus. Specifically, Levemir can be used by people who are 2 years or older. Lantus can be used by people who are 6 years or older. Levemir or Lantus can help with daily management of diabetes. However, you may still need to use short-acting insulin to treat spikes in your blood sugar levels and diabetic ketoacidosis (a dangerous buildup of acids in your blood). Learn more: All about diabetic ketoacidosis » Administration Both Levemir and Lantus are given through injection in the same way. You can gi Continue reading >>
Levemir Vs Lantus: What's The Difference?
Levemir and Lantus are both long-acting forms of insulin that work for most of the day. Levemir Vs Lantus: Both human insulin analogs Levemir is a brand name for insulin detemir. Levemir takes at least one hour to start working (some sources state up to three hours), and its effects are dependent on the initial dosage given. Dosages of 0.1 units per kg may last only six hours whereas dosages equal to or greater than 0.8 units/kg last approximately 22 to 24 hours. Levemir has a relatively peakless profile but may be more slowly absorbed from the thigh compared to the deltoid (arm) and the abdomen after subcutaneous administration. Lantus is the brand name for insulin glargine. Lantus takes approximately an hour to start working and lasts for an average of 24 hours; however, there is some variability and in some people, it may only act for just over 10 hours, whereas for others it may last longer than 24 hours. Lantus releases consistently, so doesn't really have a peak effect. Levemir Vs Lantus: Differences in formulation account for some differences in action Both Levemir and Lantus are made by modifying human insulin. Both should be clear solutions before they are injected (discard if cloudy). Insulin glargine (Lantus) tends to be absorbed more slowly and for longer than detemir ( Levemir) because it is not as soluble once injected just under the skin. This means it has a longer duration of action and an insignificant peak effect - instead, it delivers consistent blood levels of insulin. Insulin detemir (Levemir) remains soluble after injection but is able to bind to protein in the tissue and bond to itself which gives it a prolonged action. How do Levemir and Lantus compare to NPH insulin? Both Levemir and Lantus were created to improve on NPH insulin, and to better m Continue reading >>
‘generic’ Basaglar Is Cheaper Than Lantus But Does It Work?
Basaglar U-100 insulin glargine, which is a follow-on biologic insulin to Lantus is now available by prescription in the US. Basaglar, from Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. is not technically a generic to Lantus but it does have an amino acid sequence identical to Lantus and has been FDA approved as a long-acting insulin for patients of all ages with type 1 diabetes and adults with type 2 diabetes. David Kendall, M.D. and the vice president of Global Medical Affairs for Lilly Diabetes said in Lilly’s press release, “Lilly and Boehringer Ingelheim are proud to bring another proven effective diabetes treatment choice to people who may need a long-acting insulin to help control their blood sugar,” and that “We know that starting insulin can be a challenging experience for some people with type 2 diabetes. As part of our continuing commitment to the diabetes community, we are expanding our educational resources.” Is it Cheaper? Business Insider reported that Basaglar “is 15% less than the list price of Lantus and Toujeo, two long-acting insulins made by Sanofi Aventis, 21% less than the list price of Levemir, and 28% less than Tresiba, two long-acting insulins made by Novo Nordisk.” An Eli Lilly spokesperson told Business Insider that before discounts or insurance coverage, the list price for a 5-pen pack of Basaglar is $316.85. You will be able to get Basaglar from retail and mail order pharmacies. Basaglar has also been chosen for the formularies of the top three pharmacy benefit managers and is expected to be covered by many commercial insurance plans. The pharmacy benefit manager CVS Health has dropped Lantus and replaced it with Basaglar for their next year’s formulary. In their announcement, CVS Health stated that th Continue reading >>
Lantus® Is Still Your Choice
Lantus® is a long-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Lantus® should be administered once a day at the same time every day. Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Contraindications Lantus® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or one of its excipients. Warnings and Precautions Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles. Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Do not dilute or mix Lantus® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur. Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, and may be life-threatening. Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection. Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, treat and monitor until symptoms resolve. A reduction in the Lantus® dose may be re Continue reading >>
A Generic Alternative To Lantus? The Effectivness Of A Generic Insulin Glargine For Type 2 Diabetics
This study examined whether Ly 2963016 insulin glargine is safe and effective in type 2 diabetics. Patients with type 2 diabetes (T2D) generally produce insulin but it fails to work in the body. T2D is a progressive disease, and over time, the pancreas reduces insulin production. T2D patients then require insulin therapy. Insulin glargine (Lantus) is a long-acting insulin which diabetics inject once daily. It is responsible for lowering blood glucose levels over a 24 hour period. Insulin glargine (IGlar) was first developed in 1982. However, generic versions (similar but cheaper form of drug) may be developed in order to reduce costs. Ly 2963016 insulin glargine (Ly IGlar) is a generic alternative to IGlar which may be administered to T2D patients in combination with oral anti-hypoglycemic agents such as metformin (Glucophage) and glipizide (Glucotrol). It has a similar form and strength as IGlar. However, the safety and effectiveness of this drug must be established before its use can be approved. This trial aimed to determine whether Ly IGlar has a similar safety and effectiveness profile as IGlar in T2D patients. This trial involved 756 T2D patients. All participants recruited failed to produce insulin. 376 participants received Ly IGlar once daily for 24 weeks. 380 participants received IGlar once daily for 24 weeks. Patients also continued the oral anti-hypoglycemic treatments used prior to the start of the study. Participants receiving Ly IGlar had a similar decrease (-1.2%) in HbA1c (average blood glucose levels over 3 months) to those receiving IGlar (-1.34%). The proportion of patients achieving an HbA1c lower than 7% was similar in both groups after 24 weeks. The insulin dose was also similar in both groups. The number of patients experiencing side effects, al Continue reading >>
In A Race For A New And Cheaper Insulin Glargine, Legal Troubles May Delay New Products From Coming To Market
Do you ever wonder why there aren’t cheaper “generic” insulin products available? This may soon change as the patents for branded insulin begin to expire. In fact, the patents for Sanofi’s top-selling Lantus (basal insulin glargine) are set to expire in the US in 2015, and other companies are racing to produce new “generic” insulins that could provide more choices for patients and importantly, push down the prices. The term “generic” traditionally applies to small molecules that are chemically and structurally equivalent to the original drug. Biosimilars created for products like insulin are biologically created products that tend to be more complex and sensitive. Thus it is difficult to completely prove that a biosimilar drug is identical to the original like a true “generic” drug. To learn more about “generic” insulin products and how they are defined, please read on in diaTribe #26. The race has already started. On December 20, Eli Lilly and Boehringer Ingelheim announced the submission of a new basal insulin glargine to the FDA. The compound, called LY2963016, is under regulatory review in the US, Europe, and Japan. In January, we learned that Sanofi has filed a lawsuit against Lilly alleging patent violations of the original top-selling Lantus (insulin glargine) – the lawsuit could delay the FDA’s decision on drug approval for up to 30 months, which would push back potential approval to 2016. This is a bit of a surprise and we’re working on “unpacking” this to better understand the moves on each side. Other companies are getting into the game as well. Merck and Samsung Bioepsis announced a partnership in February to develop a “generic” insulin glargine, and phase 3 testing of the drug candidate will begin “soon” for its can Continue reading >>
Key Facts About Basaglar: A Less Expensive Long-acting Insulin
If you’ve been using a long-acting insulin like Lantus, you might have heard about a friendly competitor called Basaglar which is coming soon to pharmacies. Basaglar is insulin glargine known as a biosimilar (also called a follow-on biologic). Because of the manufacturing process it isn’t considered a generic, but there are no differences from Lantus in regard to safety, purity and potency. To get to know Basaglar better, here are some details you’ll want to be aware of. What is the difference between a biosimilar and a generic? Generic drugs are copies of a brand name drug, and their manufacturing process can be replicated exactly through chemical reactions. Biologics are made using manufacturing processes and living organisms that are unique to each manufacturer. Therefore, it is not really possible to make an exact copy of a biologic. For an in-depth look at the definition of biosimilar, see here. Is Basaglar less expensive than Lantus? The cost of Basaglar is estimated to be about 20% cheaper than Lantus. It is manufactured by Eli Lilly as a KwikPen. Basaglar won’t be sold in a vial form. Will my insurance switch me to Basaglar? In some cases, yes. CVS Health has announced that Basaglar will be on formulary in place of Lantus. Is it really equivalent to Lantus? Yes, the onset, peak and duration of action are almost identical. Will my dose be the same as the insulin I’m currently taking? Your healthcare provider will tell you exactly how to make the switch. In general, Lantus and Basaglar can be interchanged unit for unit. If you were on Levemir, the conversion will also be unit for unit. If you were taking Levemir twice a day, the total number of units will likely be given as one Basaglar injection. If you are switching from Toujeo or NPH, your dose might Continue reading >>
Fda Approves Cheaper Version Of Diabetes Drug Lantus
The U.S. Food and Drug Administration on Wednesday approved Eli Lilly & Co's diabetes drug Basaglar, a cheaper version of Sanofi AG's top-selling drug Lantus. The drug, an injection known also as insulin glargine, is a long-acting, man-made version of human insulin. It is the first insulin product approved through a shortened review process based on its similarity to an existing drug. The FDA determined that Basaglar was sufficiently similar to Lantus to justify approval based on the safety and effectiveness of Lantus as well as certain Basaglar-specific data. In September Lilly entered a settlement agreement to resolve patent litigation with Sanofi over Basaglar, allowing Lilly and its partner, Boehringer Ingelheim, to launch Basaglar in the United States in December 2016. The FDA tentatively approved Basaglar in August 2014. Greg Kueterman, a Lilly spokesman, said the company has not set a price for the drug, though he noted it will be cheaper than Lantus. Lantus generated sales in 2014 of more than $8 billion. Rivals have been lining up to take advantage of the drug's patent expiry to launch cheaper versions. Basaglar was approved in Europe as a biosimilar last year. The FDA is calling the product a "follow-on" biologic rather than a biosimilar. There are some 30 million people with diabetes in the United States. Continue reading >>
Basalog Is Similar To Lantus In Producing Glycemic Control In Patients With Type 1 Diabetes Mellitus On Multiple Daily Insulin Regimens
, Volume 31, Issue1 , pp 2631 | Cite as Basalog is similar to Lantus in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens This study was performed to compare the insulin glargine produced by two different manufacturers. The study determines the efficacy and safety of a new insulin glargine (Basalog) having the same amino-acid sequence as Lantus in patients with type 1 diabetes mellitus on multiple daily insulin regimen. After a run-in period of 4weeks on once-daily Lantus, patients were randomized in 1:1 ratio to receive once-daily treatment with either Basalog (n = 107) or Lantus (n = 108) for 12weeks in this open-label multicenter study. Patients were enrolled from 15 hospitals in India. Change in HbA1c was the primary efficacy parameter; FPG, 7-point glucose profile and PPG were the secondary efficacy parameters. Hypoglycemia and immunogenicity were the main safety parameters. This was a non-inferiority study where non-inferiority could be claimed if mean difference (including 95% CI) was less than or equal to 0.5% for the primary efficacy parameter HbA1c. There was no statistically significant difference between the groups with respect to change in HbA1c (p = 0.69), FPG (p = 0.25) or PPG (p = 0.68). The change in HbA1c from baseline to end-point was 7.86 1.11 to 7.80 1.24% in Basalog treated patients and 7.76 1.17 to 7.58 1.27% in Lantus treated patients. Proportion of patients achieving HbA1c <7% was also comparable (40.48% in Basalog vs 38.30% in Lantus). The nature and frequency of adverse events, percentage of patients positive for anti-insulin glargine antibodies were similar in both groups. Forty-three (40.19%) subjects on Basalog experienced at least one hypoglycaemic event, while 45 (41.67%) subjects on Continue reading >>
- The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus
- 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)
- NIHR Signal Insulin pumps not much better than multiple injections for intensive control of type 1 diabetes
Lantus And Levemir: What’s The Difference?
Lantus and Levemir have a lot in common. Both are basal insulin formulas, which means that they last for a long time in the body and act as background insulin, with a slow feed that mimics the constant low output of insulin produced by a healthy pancreas. Both are insulin analogues, which means that their insulin molecules are analogous to human insulin, but engineered, or recombined, with slight differences that slow their absorption. Lantus is a clear formula made with glargine, a genetically modified form of human insulin, dissolved in a special solution. Levemir is also a clear formula, but it contains dissolved detemir, a different form of genetically modified insulin. Human insulin is made of two amino acid chains, called A and B, that have two disulfide bonds between them. In glargine, one amino acid has been switched out, and two extra amino acids have been added to one end of the B chain. The modifications make glargine soluble at an acidic pH, but much less soluble at the neutral pH that’s found in the body To make Lantus, first the glargine is produced by a vat of E. coli bacteria. Then it’s purified and added to a watery solution containing a little zinc and some glycerol; a dash of hydrochloric acid is also added to make it acidic, bringing its pH down to about 4. At that degree of acidity, glargine completely dissolves into the watery solution, which is why the vial is clear. After you inject it into your subcutaneous tissue, the acidic solution is neutralized by your body to a neutral pH. Because glargine is not soluble at a neutral pH, it precipitates out into a form that’s not soluble in subcutaneous fat, and there forms a relatively insoluble depot. From that pool, or depot, of precipitated glargine in the tissues, small amounts slowly move back Continue reading >>
Basalog (r) Is Similar To Lantus (r) In Producing Glycemic Control In Patients With Type 1 Diabetes Mellitus On Multiple Daily Insulin Regimens
This study was performed to compare the insulin glargine produced by two different manufacturers. The study determines the efficacy and safety of a new insulin glargine (Basalog®) having the same amino-acid sequence as Lantus® in patients with type 1 diabetes mellitus on multiple daily insulin regimen. After a run-in period of 4weeks on once-daily Lantus®, patients were randomized in 1:1 ratio to receive once-daily treatment with either Basalog® (n = 107) or Lantus® (n = 108) for 12weeks in this open-label multicenter study. Patients were enrolled from 15 hospitals in India. Change in HbA1c was the primary efficacy parameter; FPG, 7-point glucose profile and PPG were the secondary efficacy parameters. Hypoglycemia and immunogenicity were the main safety parameters. This was a non-inferiority study where non-inferiority could be claimed if mean difference (including 95% CI) was less than or equal to 0.5% for the primary efficacy parameter HbA1c. There was no statistically significant difference between the groups with respect to change in HbA1c (p = 0.69), FPG (p = 0.25) or PPG (p = 0.68). The change in HbA1c from baseline to end-point was 7.86 ± 1.11 to 7.80 ± 1.24% in Basalog® treated patients and 7.76 ± 1.17 to 7.58 ± 1.27% in Lantus® treated patients. Proportion of patients achieving HbA1c <7% was also comparable (40.48% in Basalog® vs 38.30% in Lantus®). The nature and frequency of adverse events, percentage of patients positive for anti-insulin glargine antibodies were similar in both groups. Forty-three (40.19%) subjects on Basalog® experienced at least one hypoglycaemic event, while 45 (41.67%) subjects on Lantus® experienced the same. Basalog® was found to have similar efficacy and safety as Lantus® in treatment of patients with type 1 diabetes Continue reading >>
- The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus
- 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)
- NIHR Signal Insulin pumps not much better than multiple injections for intensive control of type 1 diabetes
Medimpact - Drug Information Update- Basaglar (insulin Glargine) - Medconnect
Drug Information Update- Basaglar (insulin glargine) New Drug Approval - Basaglar (insulin glargine) In December 2015, the FDA approved Basaglar (insulin glargine), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Basaglar will compete with other long-acting insulin products, e.g. insulin glargine (Lantus, Toujeo), insulin detemir (Levemir), and insulin degludec (Tresiba). Basaglar was approved under an abbreviated approval pathway known as the 505(b)(2) pathway. The 505(b)(2) application required data demonstrating that Basaglar was sufficiently similar to Lantus in addition to data regarding the safety and efficacy of Basaglar in two clinical studies. This led to the approval of Basaglar as a follow-on biologic product. Basaglar is not considered a generic or a biosimilar to Lantus and is therefore not considered interchangeable at point of sale. Basaglar is on the drug file this week. However, the manufacturer has noted that it will not go into production and will not be commercially available in pharmacies until Thursday, December 15th, 2016. Basaglar is priced 15% AWP lower than Lantus. Basaglar shares the same GCN as Lantus but is a single source brand, not a generic or biosimilar to Lantus. Basaglar is administered subcutaneously once daily. Dosing of Basaglar should be individualized based on the patients needs. Basaglar has been launched with the following strength and dosage forms: MedImpact Formulary & Utilization Management Strategies: A full clinical review of Basaglar was conducted during the MedImpact 1st Quarter 2016 Pharmacy & Therapeutics (P&T) Committee Meeting on February 5th, 2016. During this review, the Committee approved utili Continue reading >>
You Have Other Sanofi Options To Help Meet Your Patients’ Blood Sugar Lowering Needs
Lantus® is a long-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Lantus® should be administered once a day at the same time every day. Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Contraindications Lantus® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or one of its excipients. Warnings and Precautions Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles. Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Do not dilute or mix Lantus® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur. Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, and may be life-threatening. Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection. Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, treat and monitor until symptoms resolve. A reduction in the Lantus® dose may be re Continue reading >>
