FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes

TheracosBio  announced  the U.S. Food and Drug Administration (FDA)   approval of  Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Brenzavvy is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Brenzavvy is contraindicated in patients who are hypersensitive to bexagliflozin or any tablet ingredient and is not indicated for the treatment of type 2 diabetes in patients with end stage renal disease or who are receiving dialysis.

The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 adults with type 2 diabetes mellitus. Phase 3 studies showed Brenzavvy significantly reduced hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors, or combinations of these agents. Although Brenzavvy is not approved for weight or blood pressure reduction, modest decreases in both weight and systolic blood pressure have been observed in the clinical program.

“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Dr. Mason Freeman, M.D., Director of the Translational Research Center at Massachusetts General Hospital. “Being involved in all of the clinical trials for Brenzavvy, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”

Brenzavvy treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2. Patients with eGFR less than 60 and greater than 30 mL/min/1.73 m2 are said to be in stage 3 chronic kidney disease, and for these patients metformin is often avoided due to the risk of lactic acidosis.

“Today's FDA approval represents a significant milestone for TheracosBio and provides an important treatment option to patients who suffer from type 2 diabetes. We look forward to bringing Brenzavvy to market,” said Albert R. Collinson, Ph.D., President and CEO of TheracosBio. “The approval of the Brenzavvy NDA is a result of the tireless work of the TheracosBio team and investigators. I want to thank all of the patients who took part in our clinical trials.”

According to the U.S. Centers for Disease Control and Prevention, more than 33 million Americans have type 2 diabetes, which means their bodies don’t use insulin correctly and as a result their blood sugar levels are too high. While some people can control their blood sugar levels with exercise and a healthy diet, others may need additional help to achieve good blood sugar (glycemic) control.

SGLT2 inhibitors are a class of prescription medicines that lower blood sugar by causing the kidneys to remove sugar from the body through urine.

Brenzavvy is available as 20 mg oral tablets recommended to be taken once daily, in the morning with or without food.

https://en.wikipedia.org/wiki/Bexagliflozin

FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes

FDA Approves Rybelsus (semaglutide), the First Oral GLP-1 Analog Treatment for Adults with Type 2 Diabetes

In continuation of my updates on Semaglutide

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).  Rybelsus is the first and only glucagon-like peptide-1 (GLP-1) analog in a pill and a new option for adults with type 2 diabetes who are not achieving their A1C goal with current antidiabetic treatment.

Type 2 diabetes is a global public health issue that impacts more than 28 million people in the U.S. alone.2 Despite existing treatment options, many adults with type 2 diabetes have poorly managed blood sugar that can increase the risk of developing serious diabetes-related complications.

"GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment," said Vanita R. Aroda, MD, Director of Diabetes Clinical Research, Brigham and Women's Hospital, Boston, MA and a PIONEER clinical trial investigator. "The availability of an oral GLP-1 receptor agonist represents a significant development and primary care providers, specialists and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals."

The approval of Rybelsus is based on results from 10 PIONEER clinical trials, which enrolled 9,543 participants and included head-to-head studies of Rybelsus vs. sitagliptin, empagliflozin and liraglutide 1.8 mg.4 In the trials, Rybelsus reduced A1C and, as a secondary endpoint, showed reductions in body weight. The most common adverse reactions in the PIONEER trials, reported in ≥5% of patients, were nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation. The types and frequency of the adverse reactions were similar across trials.

"People living with type 2 diabetes deserve more innovation, research and support to help them achieve their individual A1C goals," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "With Rybelsus, we have the opportunity to expand use of effective GLP-1 receptor agonist therapy by providing adults with type 2 diabetes an oral medication which was previously only available as an injection to help with managing their blood sugar."

Rybelsus is approved for once-daily use in two therapeutic doses, 7 mg and 14 mg, and will be available in the U.S. beginning in Q4 2019. Initial supply of Rybelsus will come from manufacturing facilities in Denmark; however, future supply for Rybelsus will come from manufacturing facilities in the U.S. In 2015, Novo Nordisk made a strategic investment to build a new manufacturing facility in Clayton, NC to prepare for the future demand for Rybelsus. Additionally, earlier this year Novo Nordisk acquired a tableting and packaging facility in Durham, NC to meet anticipated supply needs for Rybelsus.

Novo Nordisk is working with health insurance providers with a goal of ensuring broad insurance coverage and patient access to the product. A savings card program will be available at the time of launch for eligible commercially-insured patients to keep out of pocket costs down to as little as $10 a month.

The U.S. FDA is still reviewing Novo Nordisk's new drug application (NDA) for Rybelsus seeking an additional indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease (CVD). A decision is expected in Q1 2020.

Rybelsus is currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

https://en.wikipedia.org/wiki/Semaglutide

FDA Approves Victoza (liraglutide) for the Treatment of Pediatric Patients 10 Years or Older with Type 2 Diabetes

In continuation of my update on Victoza (liraglutide)

The U.S. Food and Drug Administration   approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved to treat adult patients with type 2 diabetes since 2010.

“The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy,” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”

Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. Although type 2 diabetes primarily occurs in patients over the age of 45, the prevalence rate among younger patients has been rising dramatically over the past couple of decades. The Diabetes Report Card published by the U.S. Centers for Disease Control and Prevention estimates that more than 5,000 new cases of type 2 diabetes are diagnosed each year among U.S. youth younger than age 20.

Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. GLP-1 is often found in insufficient levels in type 2 diabetes patients. Like GLP-1, Victoza slows digestion, prevents the liver from making too much glucose (a simple sugar), and helps the pancreas produce more insulin when needed. As noted on the label, Victoza is not a substitute for insulin and is not indicated for patients with type 1 diabetes or those with diabetic ketoacidosis, a condition associated with diabetes where the body breaks down fat too quickly because there is inadequate insulin or none at all. Victoza is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; however, its effect on major adverse cardiovascular events in pediatrics was not studied and it is not indicated for this use in children.

The efficacy and safety of Victoza for reducing blood sugar in patients with type 2 diabetes was studied in several placebo-controlled trials in adults and one placebo-controlled trial with 134 pediatric patients 10 years and older for more than 26 weeks. Approximately 64% of patients in the pediatric study had a reduction in their hemoglobin A1c (HbA1c) below 7% while on Victoza, compared to only 37% who achieved these results with the placebo. HbA1c is a blood test that is routinely performed to evaluate how well a patient’s diabetes is controlled, and a lower number indicates better control of the disease. These results occurred regardless of whether the patient also took insulin at the same time. Adult patients who took Victoza with insulin or other drugs that increase the amount of insulin the body makes (e.g., sulfonylurea) may have an increased risk of hypoglycemia (low blood sugar). Meanwhile, pediatric patients 10 years and older taking Victoza had a higher risk of hypoglycemia regardless of whether they took other therapies for diabetes.

The prescribing information for Victoza includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma (MTC) should not use Victoza, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (MEN 2). In addition, people who have a prior serious hypersensitivity reaction to Victoza or any of the product components should not use Victoza. Victoza also carries warnings about pancreatitis, Victoza pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.

https://en.wikipedia.org/wiki/Liraglutide

FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes

In continuation of my update on dapagliflozin, and metformin hydrochloride

 

Dapagliflozin            Saxagliptin                                   and  (Metformin)

The US Food and Drug Administration (FDA) has approved Qternmet XR(dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).

The approval is based on two Phase III trials, which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.

In one trial, treatment with 5mg dapagliflozin/5mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in HbA1c (average blood glucose levels), and an increase in the number of patients achieving the recommended HbA1c treatment goal of <7%. In the second trial, treatment with 10mg dapagliflozin/5mg saxagliptin in addition to metformin extended release demonstrated statistically-significant decreases in HbA1c, and an increase in the number of patients achieving an HbA1c <7%.

The safety results of the individual medicines in these trials were consistent with their known profile.

About Qternmet XR

Qternmet XR is a once-daily, oral medicine compromised of the selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin, the dipeptidyl peptidase‑4 (DPP‑4) inhibitor saxagliptin and metformin hydrochloride extended release. Qternmet XR is approved in the US as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes.

https://en.wikipedia.org/wiki/Dapagliflozin

https://en.wikipedia.org/wiki/Saxagliptin

https://www.drugbank.ca/drugs/DB06335

https://www.drugbank.ca/drugs/DB00331

https://en.wikipedia.org/wiki/Metformin

FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes

Eating plant-based diet can reduce risk for heart problems in people with type 2 diabetes

Plant-based diets improve glycemic control, lead to weight loss, and improve cholesterol in people with type 2 diabetes, according to a new review published in the journal Clinical Nutrition.

Researchers reviewed nine randomized controlled trials that assessed the effectiveness of vegan and vegetarian diets for diabetes patients. The results show that those who ate a plant-based diet lowered their cholesterol, lost weight, lowered HbA1c levels, and improved other cardiometabolic risk factors when compared to those who ate a nonvegetarian diet.

More than 100 million Americans currently have diabetes or prediabetes. Those with diabetes are two to four times more likely to die from cardiovascular disease than those who do not have diabetes.

"The link between diabetes and cardiovascular disease is strong. Sixty to seventy percent of people who have type 2 diabetes die of heart disease," says study co-author Hana Kahleova, M.D., Ph.D., director of clinical research at the Physicians Committee for Responsible Medicine. "The good news is that this study shows that the same simple prescription--eating a plant-based diet--can reduce our risk for heart problems and improve type 2 diabetes at the same time."

The study authors suggest that plant-based diets, which center on fruits, vegetables, grains, and legumes, benefit both glycemic control and cardiovascular health, because they are low in saturated fat, rich in phytochemicals, high in fiber, and often rich in low-glycemic fruits and vegetables.

Previous controlled trials and prospective cohort studies have shown that a plant-based dietary pattern is associated with a lower risk of coronary heart disease, type 2 diabetes, obesity, hypertension, cardiovascular mortality, and all-cause mortality.

Ref : https://www.elsevier.com/books/vegetarian-and-plant-based-diets-in-health-and-disease-prevention/mariotti/978-0-12-803968-7#

Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.¹ Ozempic is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.

The approval of Ozempic is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, Ozempic showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.¹ As a secondary endpoint in the trials, treatment with Ozempic resulted in reductions in body weight. The most common adverse reactions reported in ≥5% of patients treated with Ozempic are: nausea, vomiting, diarrhea, abdominal pain and constipation.¹

"The Ozempic approval builds on Novo Nordisk's commitment to offering healthcare professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients' lifestyles," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "We are grateful to the many adults with type 2 diabetes who participated in the studies, as well as the clinical trial investigators. Thanks to their collective contributions, Novo Nordisk is able to bring once-weekly Ozempic to the type 2 diabetes community."

Ozempic is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen.¹

The global Phase 3a clinical trial program for Ozempic comprised eight clinical trials involving more than 8,000 adults with type 2 diabetes, including a two-year cardiovascular outcomes trial that evaluated safety in adults with type 2 diabetes at high risk of cardiovascular events.¹

"Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals," said Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, and past president of the American Association of Clinical Endocrinologists. "The approval of semaglutide offers healthcare professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals."

Novo Nordisk expects to launch Ozempic in the U.S. in Q1 2018, with a goal of ensuring broad insurance coverage and patient access to the product. Ozempic will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce co-pays for eligible commercially-insured patients. Additionally, as part of the access strategy, Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions.

Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

In continuation of my update on dapagliflozin

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity™ 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza® 0.9 mg after 52 weeks of treatment. Eli Lilly and Company (NYSE: LLY) will present these data at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston.

"These data not only reinforce once-weekly Trulicity as a safe and efficacious GLP-1 receptor agonist, but further support the value for Japanese patients, with greater A1C reductions compared to once-daily Victoza," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "We are pleased to present these study findings, which capture important information about a key region where type 2 diabetes is on the rise."

The study's primary objective was met, with Trulicity 0.75 mg demonstrating a greater A1C reduction from baseline compared to placebo at 26 weeks. At the final endpoint of 52 weeks, which is the focus of the data presentation at the meeting, Trulicity 0.75 mg demonstrated statistically greater A1C reductions compared to Victoza 0.9 mg, the highest approved dose in Japan (-1.39 percent vs. -1.19 percent). Additional results showed:

Trulicity 0.75 mg provided statistically greater reductions in the average self-monitored blood glucose levels compared to Victoza 0.9 mg (-53.1 mg/dL vs. -46.8 mg/dL); and

Trulicity 0.75 mg significantly lowered average post-meal blood glucose levels from baseline compared to Victoza 0.9 mg (-63.7 mg/dL vs. -55.4 mg/dL).

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity™ 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza® 0.9 mg after 52 weeks of treatment. Eli Lilly and Company (NYSE: LLY) will present these data at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston.

"These data not only reinforce once-weekly Trulicity as a safe and efficacious GLP-1 receptor agonist, but further support the value for Japanese patients, with greater A1C reductions compared to once-daily Victoza," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "We are pleased to present these study findings, which capture important information about a key region where type 2 diabetes is on the rise."

The study's primary objective was met, with Trulicity 0.75 mg demonstrating a greater A1C reduction from baseline compared to placebo at 26 weeks. At the final endpoint of 52 weeks, which is the focus of the data presentation at the meeting, Trulicity 0.75 mg demonstrated statistically greater A1C reductions compared to Victoza 0.9 mg, the highest approved dose in Japan (-1.39 percent vs. -1.19 percent). Additional results showed:

Trulicity 0.75 mg provided statistically greater reductions in the average self-monitored blood glucose levels compared to Victoza 0.9 mg (-53.1 mg/dL vs. -46.8 mg/dL); and Trulicity 0.75 mg significantly lowered average post-meal blood glucose levels from baseline compared to Victoza 0.9 mg (-63.7 mg/dL vs. -55.4 mg/dL).

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes

In continuation of my update on empagliflozin

The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments. Glyxambi is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Glyxambi has not been studied in patients with a history of pancreatitis, and it is unknown if using Glyxambi increases the risk of developing pancreatitis in these patients.

Glyxambi is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Glyxambi has not been studied in patients with a history of pancreatitis, and it is unknown if using Glyxambi increases the risk of developing pancreatitis in these patients.

FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes

Impotence Drug Might Counter Common Gene Mutation in Type 2 Diabetes

In a small study, Swedish researchers found that the impotence drug yohimbine might help people with type 2 diabetes who have a particular gene mutation that lowers their insulin production.

Among 50 men and women with type 2 diabetes partially caused by a mutation in a gene called alpha(2A)-AR, those treated with yohimbine showed improved insulin production and lower blood sugar levels, compared with those receiving a placebo.

"If a diabetic patient carries the risk mutation, he or she is more sensitive to stress hormones such as adrenaline," said lead researcher Dr. Anders Rosengren, head of the translational diabetes research group at Lund University Diabetes Center in Malmo.

About 40 percent of patients with type 2 diabetes carry this mutation. "It is not that patients are more stressed, but that adrenaline suppresses insulin secretion," he added.

Rosengren explained how the drug overcomes the effects of the mutation: "It is like driving a car with the brakes constantly on. If you add yohimbine, you release the brake and the car -- the insulin-producing cells -- can go at normal speed. The cells secrete adequate amounts of insulin in response to sugar."

Impotence Drug Might Counter Common Gene Mutation in Type 2 Diabetes: Study 

Isis Pharmaceuticals reports positive data from ISIS-GCGRRx Phase 2 study in patients with type 2 diabetes

Isis Pharmaceuticals, Inc.  announced positive data from a Phase 2 study of ISIS-GCGRRx in patients with type 2 diabetes uncontrolled on stable metformin therapy. In this study, patients in the per protocol efficacy population treated with ISIS-GCGRRx achieved statistically significant reductions in measures of glucose control. The absolute mean reductions in hemoglobin A1c (HbA1c) were greater than 2 percentage points>Rx also experienced increased plasma GLP-1 levels. Isis will present additional detail from this study as a late-breaking abstract program at the American Diabetes Association 74th Scientific Sessions. In conjunction, Isis will host an investor event on June 15, 2014 at 7:00 a.m PT. 

"These results reported today represent the potential for a major advance in diabetes therapeutics. ISIS-GCGRRx employs a unique mechanism to treat patients with type 2 diabetes. It is well known that as type 2 diabetes progresses, dysregulated glucagon action becomes a more significant contributor to the disease. The ability of ISIS-GCGRRxto improve glycemic control without causing any clinically significant increases in blood pressure or lipids offers a significant advantage for both patients and treating physicians," said Robert Henry, M.D., chief, VA endocrinology & metabolism and professor of medicine in residence, University of California, San Diego School of Medicine. "The additional effect on increasing GLP-1 means that ISIS-GCGRRx treatment could help to preserve pancreatic function and enhance insulin secretion in diabetic patients."

Isis Pharmaceuticals reports positive data from ISIS-GCGRRx Phase 2 study in patients with type 2 diabetes

Farxiga Approved for Type 2 Diabetes - Drugs.com MedNews

In continuation of my update on Farxiga

Farxiga (dapagliflozin) has been approved by the U.S. Food and Drug Administration to treat adults with type 2 diabetes, the agency said Wednesday in a news release.

The drug, to be used for blood sugar control along with proper diet and exercise, is designed to prevent re-absorption of glucose by the kidneys. Type 2 diabetes affects some 24 million people, accounting for 90 percent of diabetes cases in the United States, the FDA said.

Farxiga Approved for Type 2 Diabetes - Drugs.com MedNews

In continuation of my update on canagliflozin/Invokana...

We know that, Canagliflozin (Invokana) is a drug for the treatment of type 2 diabetes. It was developed by Mitsubishi Tanabe Pharma and is marketed under license by Janssen, a division of Johnson & Johnson. Canagliflozin is an inhibitor of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter causes blood glucose to be eliminated through the urine. In March 2013, canagliflozin became the first SGLT2 inhibitor to be approved in the United States...

FDA Approves Invokana to Treat Type 2 Diabetes

FDA Approves Invokana to Treat Type 2 Diabetes

In continuation of my update on Canagliflozin

We know that, Canagliflozin (Invokana) is drug for the treatment of type 2 diabetes developed by Johnson & Johnson. In March 2013,  canagliflozin became the first in a new class of drugs for diabetes treatment to be approved. It is an inhibitor of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter causes blood glucose to be eliminated through the urine..

FDA Approves Invokana to Treat Type 2 Diabetes

Takeda Receives FDA Approval for Kazano (alogliptin and metformin) for Type 2 Diabetes

Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Kazano (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. 

Kazano contains alogliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). Kazano combines alogliptin with metformin HCl, a widely used anti-diabetes medication, in a single tablet.

The most common adverse events (greater than or equal to 4%) reported with alogliptin include nasopharyngitis, headache and upper respiratory tract infection. Common adverse events (greater than or equal to 4%) reported with Kazano include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.

Takeda is committed to providing type 2 diabetes patients with treatment options that help address their needs, and is planning to commercially launch Kazano in the summer of 2013.

Takeda's consolidated financial statements for the 2012 fiscal year will not be impacted by the FDA approvals.

Takeda Receives FDA Approval for Kazano (alogliptin and metformin) for Type 2 Diabetes

Meta-analysis links increased magnesium intake with fasting glucose and insulin reductions...

"Evidence from cross-sectional and longitudinal observational studies suggests that diets higher in magnesium are associated with reduced risk of insulin resistance and type 2 diabetes, whereas in intervention studies, supplemental magnesium improves measures of glucose and insulin metabolism in generally healthy adults, as well as in those with insulin resistance and type 2 diabetes," Adela Hruby and colleagues write. "However, little is known about potential interaction between magnesium intake and genetic variability on glycemic traits, in which genetic variants related to either magnesium transport and homeostasis or glucose and insulin metabolism may modify the pathways through which magnesium exerts its effects."

The researchers analyzed data from up to 52,684 nondiabetic men and women who participated in 15 studies included in the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) Consortium. Dietary questionnaire or interview responses, or food diary entries were analyzed for magnesium content from food and beverages. Participants were genotyped for up to 25 single nucleotide polymorphisms related to fasting glucose, insulin or magnesium.  Average magnesium intake ranged from 224.7 milligrams to 479.7 milligrams per day. Reductions in both fasting glucose and fasting insulin were observed in association with increased magnesium. While a nominal association was found between one of the genetic variants examined in this study and fasting glucose and two variants showed nominal interactions with magnesium intake on fasting glucose and fasting insulin, no significant effects for the variations were observed......... 

Ref : http://jn.nutrition.org/content/early/2013/01/22/jn.112.172049.abstract?sid=0219d7a7-cc12-4709-8167-805f0663e750

More..

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes: 

In continuation of my update on dapagliflozin and sitagliptin

The study also demonstrated significant reductions in total body weight and fasting plasma glucose (FPG) levels in patients taking dapagliflozin added to sitagliptin (with or without metformin), with results maintained throughout the duration of the study extension.

Patients were actively questioned at each study visit for signs, symptoms or events suggestive of genital infections and urinary tract infections. These events were more frequent with the dapagliflozin treatment group compared to the placebo treatment group, and were generally mild to moderate in intensity, with most patients responding to standard treatment.

"Type 2 diabetes is a complex disease that often requires patients to take multiple treatments to control their blood sugar levels, with DPP4 inhibitors being some of the most widely prescribed therapies," said Serge Jabbour, M.D., Division Director of Endocrinology, Thomas Jefferson University. "In this study, dapagliflozin, in addition to diet and exercise, resulted in reduced blood sugar levels when added to sitagliptin, a DPP4 inhibitor. These findings add to our understanding of the effect of dapagliflozin in combination with commonly prescribed type 2 diabetes treatments."

Bristol-Myers Squibb Company and AstraZeneca today announced results from a Phase 3 clinical study that showed the investigational compound dapagliflozin 10 mg demonstrated significant reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with type 2 diabetes.

More..

Lexicon presents six posters on LX4211 at ADA meeting

 

Lexicon presents six posters on LX4211 at ADA meeting: Lexicon Pharmaceuticals, Inc. will present six posters summarizing the mechanism of action and safety of LX4211, a dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) currently in mid-stage development for type 2 diabetes, at the 72nd Scientific Sessions of the American Diabetes Association (ADA) in Philadelphia, Pennsylvania during the Saturday morning poster session on June 9, 2012. 

Lexicon has completed dosing in a Phase 2b study of LX4211 in 299 patients with type 2 diabetes and expects to report top-line results at the end of June.

 

Experimental Drug Shows Promise Against Type 2 Diabetes

In continuation of my update on TAK 875

Experimental Drug Shows Promise Against Type 2 Diabetes: An experimental drug improves patients' blood sugar control without increasing the risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, according to the results of a phase 2 clinical trial.

Type 2 diabetes is...

FDA Approves Korlym for Patients with Endogenous Cushing's Syndrome..

Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women....

Ref : http://www.corcept.com/medicationguide.pdf

FDA Approves BYDUREON™ -- The First and Only Once-Weekly Treatment for Type 2 Diabetes

In continuation of my up date on Exenatide...

Amylin Pharmaceuticals, Inc. and Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon  (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes. Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings....

More...