Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Insulin Glargine is basically used as a treatment for Type-1 diabetes, a condition in which the body is not able to produce enough insulin, and as a result, is unable to control the amount of sugar in the blood stream. In recent clinical trials, a fixed ratio combination of Insulin Glargine along with Lixisenatide, which is a GLP-1 RA was shown to have superior reduction in the average blood glucose levels as compared to past clinical trials. Insulin Glargine is an analogue of human insulin which has been modified to provide a consistent supply of plasma insulin in those people who have been diagnosed with Type-1 and Type-2 diabetes. Both Type-1 and Type-2 diabetes can pose major problems for the body, which is one of the reasons why diabetes is called “the silent killer”. Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1).
This entry was posted in Anti-Diabetic, Drug Research & Development API, Patent Expiration 2023, Therapeutic Classification and tagged anti-diabetic by admin. LMC is looking for individuals with Type 1 Diabetes to participate in a research study involving an experimental insulin medication that may help lower meal-time glucose levels. We have over 40 years of combined & trusted experience conducting clinical research studies to thoroughly test new medications or medical devices for safety and efficacy. Healthcare PolicyAssess the impact of a changing regulatory environment on your business with analysis of the latest changes in policy. Pricing & ReimbursementStay ahead of the ever changing global pricing landscape with in-depth analysis of industry developments and pricing trends. Research & DevelopmentRead about the latest drug trials, releases, and industry developments – and understand how they will affect market pricing and access. Tresiba, a basal insulin, was recently launched by NovoNordisk in Japan(the drug was approved in Europe in October 2012). In-spite of this hoopla there are many facets of treatment paradigm, often overlooked, within diabetes with patient adherence being at the top. In spite of this aggressive treatment strategy, there are some fundamental challenges which need immediate attention to make the treatment more effective and engaging. Over the years, the evolution of insulin production and administration has been quite astonishing.
The evolution of insulin is not only limited to the method of production but also to the mode of delivery. There is no doubt that the overall quality of care has improved in diabetes in the last 50 years, but there is a greater need to increase patient adherence which has remained stubbornly low. Diabetes is a challenging disease to manage and the most difficult challenge for physicians in diabetes management is the regimen adherence, which is extremely crucial for glycemic control. This multidimensional adherence regimen with different components poses a dilemma for the ongoing clinical practice. According to results of the DAWN study, patients rate the clinical efficacy of insulin as low and would blame themselves if they had to start insulin therapy – an attitudinal factor affecting adherence to overall therapy. Both attitudinal and behavioural factor poses a unique dilemma in engaging the patient effectively towards therapy. According to a recent study published by The American Journal of Pharmacy Benefits, in US alone, the inflation adjusted per-capita non-adherence cost of diabetes ranges from $4007 to $6100 (approximately). According to our team’s research with American Diabetes Association, Diabetes has reached epidemic proportion in the US with nearly 26 million adults and children living with the disease. No wonder that with figures like these, there is global outcry in healthcare systems to reduce the overall cost burden. In the case of diabetes, there is no doubt that the overall treatment paradigm has greatly evolved in the last decade with better drug delivery systems and genetically enhanced insulin products making patient’s lives better.
Praful Mehta is a senior life sciences analyst for IHS and is responsible for the development of new tools, platforms and capabilities.
About the Life Sciences BlogIndustry insights from the IHS Markit Life Sciences team covering market access, pricing and reimbursement, emerging markets, generics strategies, therapeutic development pathways, forecasting and market sizing, and general competitive intelligence. In addition, treatment with JARDIANCE resulted in a lower risk of all-cause mortality (32 percent reduction) and hospitalization for heart failure (35 percent reduction). Life expectancy of people with T2D at high CV risk is, on average, decreased by up to 12 years with approximately 50 percent of deaths in people with T2D caused by CV disease. These data were presented today at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden, and simultaneously published in the New England Journal of Medicine. EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries with type 2 diabetes at high risk for cardiovascular events. The study was designed to assess the effect of JARDIANCE (10mg or 25mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including blood pressure and cholesterol-lowering medications). Of the 7,020 treated patients, more than 97 percent completed the trial and vital status was available for more than 99 percent of these patients at study end. JARDIANCE is a once-daily pill taken in the morning, used along with diet and exercise, to lower blood sugar (A1C) in adults with type 2 diabetes.


JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up.
Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE. If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Low blood sugar (hypoglycemia): if you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher.
Kidney Problems, especially in people 75 years of age or older and people who already have kidney problems.
Urinary Tract Infection: symptoms may include burning feeling when passing urine, pain in the pelvis or back, or urine that looks cloudy.
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females. For more information, please see Full Prescribing Information, including Patient Information. In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about empagliflozin as a treatment for patients with type 2 diabetes along with diet and exercise and reflects Lilly’s current belief. Current guidelines by the American College of Obstetricians and Gynecologists state that moderate caffeine consumption, or less than 200 mg per day, is most likely safe for your baby.
Please note that we are unable to respond back directly to your questions or provide medical advice.
As the fastest growing consumer health information site a€” with 65 million monthly visitors a€” Healthlinea€™s mission is to be your most trusted ally in your pursuit of health and well-being. It is also used for the treatment of Type-2 diabetes where the body is unable to use insulin normally. Overall, the fixed ratio combination showed to have a safety profile which reflected those of insulin Glargine and Lixisentide. Rest assured you will get premium quality API products along with the continuous support of our team throughout the R&D process.
While the drug could also be used for other medical conditions it is not to be used by patients who are experiencing diabetic ketoacidosis.
We are one of the largest networks of fully-owned and integrated outpatient clinical research sites in North America. The company has hailed the drug as better than existing insulin products, with a lower risk of hypoglycaemia, and as offering the promise of a better quality of life.
It is normally used by all patients with type-1 diabetes and when diet and other oral drugs have failed to manage the blood sugar in the body for patients with type-2 diabetes.
It has undergone a tremendous change - from multiple injections routines to twice daily regimen to continuous subcutaneous insulin infusion through pumps. According to the research published in the Journal of Clinical Diabetes, it has been shown that diabetes regimen is multidimensional, and adherence to one regimen component may be unrelated to adherence in other regimen areas. However, a closer analysis of therapeutic component reveals interesting insights on patient adherence. However, patients who are not managing their diabetes well (poor perceived control, more complications, and diabetes related distress) are significantly more likely to see insulin therapy as potentially beneficial – a behavioural factor affecting adherence to therapy.
One common factor (acknowledged by both physicians and patients) attributable to the low adherence rates and directly affecting patient engagement is the frequency of administration. Poor adherence usually leads to lower success rates for treatment to target levels, increased adverse clinical outcomes (especially CV related), and overall mortality. An additional 79 million have prediabetes, placing them at increased risk for developing type 2 diabetes. However, it is ironic that in the advent of reducing overall healthcare cost, governments are so concerned about the benefits coverage, product pricing, and deep budget cuts but are completely ignoring patient adherence.
It ensures a win-win solution to all the stakeholders in the healthcare system - improving quality of life for patients, increasing access to medicines for the pharmaceutical industry, reducing healthcare costs through systemic savings, and ensuring an overall better quality of human life. Praful has been a long-time advisor to senior teams within the pharma industry on issues of market competitiveness, business integration, and commercialization strategies. The incidence of diabetic ketoacidosis was at or below 0.1 percent and similar across all treatment groups.


There were 772 primary outcome events in the EMPA-REG OUTCOME trial over a median observation period of 3.1 years.
The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. Analyses and results were independently validated and confirmed by the University of Freiburg, Germany, an internationally renowned academic center specializing in statistical analyses.
Men who take JARDIANCE may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections.
Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar such as insulin. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Both of which will support, guide, and inspire you toward the best possible health outcomes for you and your family. Focus on engaging the large muscles of the buttocks.Hold for 3 seconds, return to starting position. Insulin Glargine is a synthetic version of insulin which is long lasting and works by replacing the insulin which is naturally produced by the body in order to move sugar from the blood to other parts of the body, where it is stored and used for energy. According to the researchers, the meeting of the primary objectives of this clinical trial showcases the clinical value of Insulin Glargine. Those who have Type-2 diabetes are unable to use insulin in the proper way, resulting in an increase of sugar in the blood. However, there is a growing trend amongst specialists for adopting the early use of insulin in type-2 diabetes treatment pathways. Then, scientists came up with technological breakthrough to prepare recombinant human insulin in E.coli bacteria--commonly known as synthetic insulin.
Pharmaceutical companies have been very active in inventing better methods of drug delivery, reducing the overall dose frequency and launching re-usable delivery systems, to increase overall adherence. Patients taking a once-daily dose have reported a greater compliance than compared to those taking three or more doses of medication. Non-adherence also leads to increased utilisation of systemic healthcare resources and greater costs for all the stakeholders.
Moreover, Diabetes caused $245 billion dollars of total healthcare expenditure in 2012, as compared to $174 billion dollars in 2007. Even slight improvements in adherence could bring substantial systemic cost savings in the long run. There was a 38 percent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. T2D is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S.
By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.
Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that empagliflozin will receive additional regulatory approvals. While the pancreas does make more insulin at the beginning to make up for the loss, over time, it is unable to keep up and cannot make enough insulin to keep blood glucose levels at a normal range. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.



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