BARCELONA, Spain For patients newly diagnosed with type 2 diabetes, the recommended strategy of initiating treatment with metformin and then stepping up treatment with a second agent if monotherapy fails to control blood glucose might not be ideal, a new large, 5-year trial suggests.

Rather, initial dual therapy may be better.

Among patients with newly discovered diabetes whose HbA1C level was 6.5% to 7.5% (48 58 mmol/mol), those who initially received combination therapy with metformin plus the dipeptidyl peptidase4 (DPP-4) inhibitor vildagliptin (Galvus, Novartis) were less likely to experience sustained treatment failure (HbA1C 7% [53 mmol/mol]) during a 5-year period.

Lead investigator David R. Matthews, DPhil, EASD president and professor emeritus of diabetic medicine, University of Oxford, in the United Kingdom, and two coinvestigators presented these findings from the Vildagliptin Efficacy in Combination With Metformin for Early Treatment of Type 2 Diabetes (VERIFY) trial here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting. The findings were simultaneously published in the Lancet.

This is the largest long-term prospective trial to test the durability of glycemic control in patients with diabetes who were initially treated with dual combination therapy, Ofri Mosenzon, MD, and Gil Leibowitz, MD, from Hebrew University of Jerusalem, Israel, write in an editorial that accompanies the Lancet article.

The study should "reassure" clinicians that initial dual therapy with these two agents "is well tolerated, safe and effective," they note.

Moreover, this finding was not unexpected, because these medications have synergistic mechanisms: metformin increases insulin sensitivity, and vildagliptin enhances beta-cell function.

The study "strengthens the notion that early combination therapy could have long-term clinical benefits regarding glycemic durability," they summarize.

They note, however, that in recent years, a number of large trials have shown that newer glucose-lowering agents, mainly GLP-1-receptor agonists and SGLT2 inhibitors, "have cardiovascular and renal benefits and the place of metformin as the first drug for all patients with type 2 diabetes is [now] questioned."

VERIFY coauthor Michael Stumvoll, MD, University Hospital Leipzig, Germany, told Medscape Medical News that VERIFY was begun long before most current GLP-1 agonists and all SGLT2 inhibitors were available.

When recruitment for VERIFY began in 2012, "we were in a world where gliptins were just becoming fashionable," Stumvoll said.

"Vildagliptin a beta-cell-preserving, weight-neutral, safe drug was leading the market," he said.

Vildagliptin is still widely used around the world, he stressed.

"It's a 'fire and forget' type of thing, a fixed dose, one in the morning and in the evening," and clinicians don't need to worry about impaired kidney function, weight gain, or hypoglycemia, he said.

Some practitioners have been using initial combination therapy off label, he added. This trial provides evidence to support this practice.

About 40% of patients did not experience treatment failure on metformin monotherapy.

However, Matthews said, "The point is, you don't know who these patients [who do well on monotherapy] are."

"What I think is important," senior author Stefano Del Prato, MD, University of Pisa, Italy, told Medscape Medical News, is that this is the first large, randomized clinical trial that shows that "a combination of the two drugs that are known to be safe...can preserve glycemic control over time." His words echo the comments of the other speakers and editorialists.

He said that further study is needed to see whether improved glycemic control lowers risk for cardiovascular disease.

VERIFY was designed to determine whether clinicians should start with combined therapies or use a stepwise approach (starting with metformin and then adding vildagliptin if metformin failed to provide adequate glycemic control) for patients with diabetes, Matthews said.

From 2012 to 2014, VERIFY enrolled 2001 patients who had been newly diagnosed with type 2 diabetes in 254 centers in 34 countries.

The patients were 18 to 70 years old and had been diagnosed with type 2 diabetes within the previous 2 years.

In these patients, the range of HbA1C, level was narrow, at 6.5% to 7.5%, Stumvolt noted. Body mass index values ranged from 22 to 40 kg/m.

The patients were randomly assigned either to the early combination treatment group (998 patients) or to the initial metformin monotherapy group (1003 patients).

Those in the combination therapy group received metformin at a dose of 1000 mg, 1500 mg, or 2000 mg per day, plus vildagliptin at a dose of 50 mg twice daily.

The patients in the monotherapy arm received the same daily doses of metformin plus twice-daily placebo.

If at any time from 6 months to 5 years from the start of the trial the HbA1C level was not maintained below 7.0% with initial treatment (confirmed at two consecutive scheduled visits that were 13 weeks apart), patients in the metformin monotherapy group were given vildagliptin 50 mg twice daily (instead of placebo) in addition to metformin.

About 80% patients in each group completed the 5-year study.

During the first phase of the study (before therapy was stepped up for any patients receivingmonotherapy) 429 patients (43.6%) in the combination treatment group and 614 patients (62.1%) patients in the monotherapy group experienced treatment failure.

The median time to treatment failure was 36 months in the monotherapy group; treatment failure had not occurred by 5 years in the combination therapy group.

The risk for treatment failure was 49% lower with initial combination therapy than with initial monotherapy (hazard ratio, 0.51; P < .0001).

Both treatment approaches were safe and well tolerated. There were no unexpected or new safety findings, and no deaths occurred that were related to study treatment.

Early combination therapy was not associated with risk for hypoglycemia or increased body weight, Del Prato noted.

An ADA-EASD consensus report states that currently, "While there is some support for initial combination therapy due to the greater initial reduction of A1C than can be provided by metformin alone, there is little evidence that this approach is superior to sequential addition of medications for maintaining glycemic control or slowing the progression of diabetes."

According to Del Prado, on the basis of VERIFY, the wording should be changed to "there is now evidence...."

The study can only generate hypotheses regarding cardiovascular risk, because it was not designed to examine this. He believes, however, that the study is "opening up a new era" in diabetes treatment strategies.

VERIFY demonstrated durable glycemic control in a heterogeneous population that reflects typical patients with newly diagnosed type 2 diabetes who are seen in clinical practice, he summarized

"Whether early combination treatment strategy should be applied to all patients with type 2 diabetes" needs to be studied further, according to Mosenzon and Leibowitz.

The findings from VERIFY "suggest that early normalisation of blood glucose has a beneficial legacy effect that attenuates diabetes progression," the editorialists write.

Other studies have shown that normalizing blood glucose during the first year after diagnosis "was associated with decreased risk of microvascular and macrovascular complications," they state.

Often in clinical practice, treatment intensification is delayed, and patients are exposed to prolonged hyperglycemia.

"Early combination therapy with two or more glucose-lowering agents might become an effective strategy to prevent clinical inertia," they suggest.

On the other hand, combination treatment might increase the risk for side effects and is more costly. "Additional studies are needed to confirm that early combination treatment indeed halts the progression of diabetes," they write.

Many type 2 diabetes drugs are currently available that could be combined as initial dual therapy. Thus, "Further studies to assess the effects of different combination therapies on glycaemic durability and more importantly on the risk of late complications are necessary," they write.

The study was funded by Novartis. Matthews has served on advisory boards or as a consultant for Novo Nordisk, GlaxoSmithKline, Novartis, Eli Lilly, Sanofi-Aventis, Janssen, and Servier. He is currently the president of the European Association for the Study of Diabetes and has given lectures for Novo Nordisk, Servier, Sanofi-Aventis, Eli Lilly and Company, Novartis, Janssen, and Ach Laboratories. Stumvolt has received speaker's honoraria and consulting fees from Novartis, Novo Nordisk, AstraZeneca, Aegerion, Eli Lilly and Company, and Boehringer Ingelheim. Del Prato serves or has served on advisory boards for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline, Hanmi Pharmaceuticals, Intarcia, Janssen Pharmaceutics, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi, Servier and Takeda; serves or has served on the speakers' bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen Pharmaceutics, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi and Takeda; and has received research support from Boehringer Ingelheim, Merck Sharp & Dohme, and Novartis. The three other coauthors are employed by and own stock in Novartis. Mosenzon has received advisory board and speaker's fees and a research grant through her institution from Novo Nordisk; advisory board and speaker's fees from Eli Lilly, Sanofi, Merck Sharp & Dohme, and Boehringer Ingelheim; advisory board and speaker's fees and a research grant through her institution from AstraZeneca; and speaker's fees from Teva that are unrelated to the editorial topic. Leibowitz has received advisory board and speaker's fees from Novo Nordisk; speaker's fees from Eli Lilly & Company; and advisory board and speaker's fees from Sanofi and AstraZeneca that are all unrelated to the editorial topic.

European Association for the Study of Diabetes (EASD) 2019 Annual Meeting: Presented September 19, 2019.

Lancet. Published online September 18, 2019. Abstract, Editorial

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VERIFY: Metformin + DPP-4 Inhibitor as Dual Therapy for Diabetes? - Medscape

BARCELONA A novel investigational first-in-class drug called imeglimin (Poxel Pharma) has shown promise in treating type 2 diabetes in a phase 3 study conducted in Japan.

Findings from the Trials of Imeglimin for Efficacy and Safety (TIMES) clinical development program were presented September 18 during a symposium here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting by Julie Dubourg, MD, Poxel's medical director of clinical development.

"In all phase 2 and phase 3 trials, imeglimin has demonstrated very robust efficacy in the type 2 diabetic population, as well as in subpopulations such as elderly patients and those with chronic kidney disease. The safety and tolerability profile is also very good. So this [may be] a new option for the treatment of patients with type 2 diabetes as mono- or add-on therapy," Dubourg told Medscape Medical News.

Imeglimin works by improving mitochondrial function, which in turn increases insulin secretion and insulin sensitivity in the muscle while also decreasing hepatic glucose production, Ralph A. DeFronzo, MD, professor of medicine and chief of the diabetes division at the University of Texas Health Sciences Center, San Antonio, said during the symposium.

Imeglimin is the first of what will be a new "glimin" class of glucose-lowering agents.

"These drugs actually correct three of the big problems that are present in our diabetic patients...It provides us with a new mechanism of action," DeFronzo said.

In addition, because preclinical data suggest that imeglimin also mobilizes fat in the liver, "this drug also has the potential to be used in [nonalcoholic steatohepatitis]," he noted.

Asked to comment, Harold E. Lebovitz, MD, professor of medicine at the State University of New York-Brooklyn, said: "The Japanese data are very impressive, but we don't know yet how other populations will respond to it."

"It is clearly a new class with unique mechanisms, but we have to define what that role is," he added.

Lebovitz, who conducted early studies on imeglimin but isn't involved in its development now, also pointed out that the drug could work in some patients for whom other classes of glucose-lowering agents might not be effective, or appropriate, such as those with kidney disease.

"Glucose-lowering drugs are not all for the same group of people...People with kidney disease are very sensitive and have a lot of hypoglycemia...Every drug is probably useful for a subset of patients because type 2 diabetes is not a single disease."

The ongoing phase 3 TIMES program with imeglimin includes three individual randomized, double-blind, placebo-controlled trials involving more than 1100 patients at 29 sites in Japan. TIMES 1, a 6-month monotherapy efficacy trial, TIMES 2, a 1-year safety trial with imeglimin as mono- and add-on therapy, and TIMES 3, a 16-week efficacy trial of imeglimin added to insulin, followed by a 36-week safety extension period.

Dubourg reported the results of TIMES 1 here at the EASD annual meeting. Patients had had type 2 diabetes for more than 3 months, were aged 20 years or older, were managed with diet and exercise, with or without one oral agent, and had a baseline HbA1c of 7-10%. Rescue therapy could be given after week 4 if necessary. A total of 213 participants were randomized and 205 completed the trial (103 were randomized to imeglimin and 102 to placebo).

The primary endpoint, change from baseline in HbA1c at week 24, was significantly greater with imeglimin compared to placebo (0.87%; P < .0001), consistent with results seen in a phase 2 trial that was pivotal in selecting the 1000-mg dose of imeglimin for the phase 3 trials, Dubourg said.

Fasting plasma glucose also dropped significantly at 24 weeks by an average of 19 mg/dL (P < .0001), also similar to the phase 2 results.

Proportions of patients achieving an HbA1c < 7% were 35.8% (from baseline of 7.99%) in the imeglimin group versus just 7.5% (from a baseline of 7.93%) with placebo. No patient in the imeglimin group required rescue therapy, whereas 5.7% of the placebo group did.

Results were consistent across age groups, above and below 65 years of age (both P < .0001), and across chronic kidney disease stages 1, 2, and 3 (P < .0900, P < .0001, and P = .0007, respectively).

Overall adverse event rates were similar (44.3% vs 44.9% for imeglimin and placebo, respectively). Gastrointestinal disorders occurred in 11.3% of patients with imeglimin versus 8.4% with placebo. There were no severe hypoglycemic events in either group.

Adverse events leading to study discontinuation were less common with imeglimin than placebo (2.8% vs 5.6%). Serious adverse events were more common with imeglimin (3.8% vs 0.9%). No deaths occurred.

TIMES 2 and TIMES 3 results are expected around the end of 2019.

Poxel expects to submit a New Drug Application for imeglimin in Japan by the end of 2020. Phase 3 trials will also be conducted in the United States and Europe.

EASD 2019 Annual Meeting. Presented September 18, 2019.

Dubourg is a Poxel employee. DeFronzo has reported being an advisor for, receiving research support from, and/or being a speaker for AstraZeneca, Novo Nordisk, Janssen, Boehringer-Ingelheim, Intarcia, Elcelyx, Janssen, and Merck. Lebovitz formerly consulted for Poxel but hasn't done so for more than a year and currently receives no funding from them. He now works with Indian biosimilar manufacturer Biocon.

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Novel Agent Imeglimin Improves Glucose Control in Type 2 Diabetes - Medscape

BARCELONA Metabolic signs of type 2 diabetes are detectable in the blood of some children as young as 8 years old, according to the results of a large epidemiological study presented here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting.

"It's remarkable that we can see signs of adult diabetes in the blood from such a young age this is about 50 years before it is commonly diagnosed," said lead researcher Joshua Bell, PhD, MRC Integrative Epidemiology Unit, University of Bristol, UK.

Bell and colleagues used data from the Avon LongitudinalStudyof Parents and Children (ALSPAC) study to look at the early features of type 2 diabetes in children aged 8 and older.

The researches assessed genetic liability in the kids using variants known to be associated with adult diabetes and calculated a genetic risk score, which was cross-referenced with metabolic markers in the blood measured at four time points as the children grew up, until the age of 25. The full articleis also available online.

"This was a way of trying to piece together what the disease looks like as it's developing," he told Medscape Medical News.

Specifically, one of the earliest features to change in the blood was metabolism of high-density lipoprotein cholesterol (HDL-C) or "good" cholesterol. Low levels of this marker appeared to be correlated with higher genetic likelihood of developing type 2 diabetes in adulthood, Bell explained

These changes occurred before any alterations in low-density lipoprotein cholesterol (LDL-C) or "bad" cholesterol.

Session moderator Naveed Sattar, MD, from the Institute of Cardiovascular & Medical Sciences at the University of Glasgow, UK, welcomed the work but pointed out that it is unlikely this information would be used clinically, at least at the present time.

"It does add a little bit of new information on what the pathways to diabetes may be so only of research interest currently not for the clinic for many years, if ever," he observed.

"We already have good risk scores based on questions and simple measurements of weight or waist...which help signal those at high risk [of diabetes] who should consider getting tested for it," he added.

Bell explained that type 2 diabetes takes many years to develop and, based on adult data, it has been established that disease-related changes can occur in the decade or two leading up to diagnosis.

"What we don't know is what the very early beginnings of disease look like," he explained.

Using the ALSPAC data (also known as the cohort of the 90s study), Bell and colleagues genotyped 4765 children for 162 genetic variants of adult type 2 diabetes and also examined lipid measures including triglycerides as well as a number of amino acids and fatty acids in blood samples taken at ages 8, 15, 18, and 25 years.

"We wanted to know the effect of that genetic susceptibility on blood markers. How early in life do we see the beginning of disease activity? And how does it unfold?" he told Medscape Medical News.

He acknowledged the findings "are more preclinical than clinical," but stressed they provide some early insight into "what features might be targeted to prevent progression to clinical disease."

Elizabeth Robertson, PhD, director of research at Diabetes UK, said the findings may indeed be of use in years to come.

"In the future, insights like these could mean we're able to spot who is at a higher risk and most importantly find ways to intervene to reduce this risk much earlier in a person's life than we're able to today and...potentially prevent more cases of type 2 diabetes from developing at all," she commented.

"Although we can't do anything about our genetic risk, there are things you can do to help lower your risk of developing the condition that include maintaining a healthy weight, eating well, and moving more," she noted.

EASD 2019 Annual Meeting. Presented September 19, 2019. Abstract 81.

Bell has reported no relevant financial relationships.

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Read more:
Blood Lipid Changes at Age 8 in Kids Genetically Prone to Diabetes - Medscape

One Drop, the digital health specialist that markets diabetes management tools, has found a new partner and investor in Bayer. The German pharma led One Drops $40 million series B round and licensed its technology for its bio-digital efforts in areas beyond diabetes.

New York-based One Drop offers hardware and software to help people manage their diabetes, including a Bluetooth-enabled blood glucose meter, test strips and lancets as well as a mobile app and various coaching programs. These are available individually or as part of a gestational diabetes package or a subscription-based diabetes package.

The One Drop app works with FitBit trackers and Dexcom glucose monitoring systems on iPhone and Android devices. Apple has even begun selling One Drops chrome-plated glucose meter alongside its iPhones and Apple Watches in some of its U.S. retail stores. These integrations, One Drop says, are why its reach is so deep. It estimates that nearly 1.5 million people in 195 countries use its technology.

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RELATED: Apple stores to stock chrome-plated glucose monitor from One Drop

Though aimed at diabetes, One Drop believes its platform could be used to track and manage a range of health conditionsand Bayer agrees. The Big Pharma will harness One Drops mobile platform across a broad array of therapeutic areas including oncology, heart disease and womens health.

"As part of our strategy to shape the future of healthcare and build new businesses in digital health, we are investing in integrated digital solutions to improve health outcomes through data driven solutions, said Stefan Oelrich, president of Bayers pharmaceuticals division, in a statement. "This collaboration allows us to obtain access to a world leading self-care platform for disease management beyond the boundaries of medicines with strong artificial intelligence-driven capabilities that could lead to better healthcare outcomes for people with chronic conditions."

As for the new $40 million infusion, One Drop will use it to invest in its growth and to further its mission to transform the lives of people with diabetes and other chronic conditions, Rachel Snchez-Madhur, vice president of consumer strategy and marketing, told FierceMedTech in an email.

This year will see continued growth in our consumer channels, and rapid growth in our employer channel, and an expanded effort to drive further ahead with our data science operations, she said.

Continued here:
Bayer steps up to take One Drop's tech beyond diabetes, backs $40M round - FierceBiotech

Pixabay Doctors may soon look into your eyes to see your risk of having diabetes. Researchers found that eye lens show changes in the body that may predict the disease even years before its development.

The new study, presented at the recent meeting of the European Association for the Study of Diabete (EASD) in Spain, used a newly developed biomicroscope to observe advanced glycation end-products (AGEs) in the eye. High levels of AGEs can contribute to a number of diseases, including eye nerve damage and neuropathy.

The biomicroscope sends blue light to the eye lens to measure its autofluorescence and inform researchers aboutthe levels of AGEs. Researchers tested the device in a healthy control group and 40 people diagnosed with either prediabetes or type 2 diabetes.

Each participant underwent comprehensive medical and neurological assessments prior to the study. They then took tests with the biomicroscope to measure their lens autofluorescence.

Results showed that autofluorescence in the lens of the eye could help predict a persons diabetes risk. The people with type 2 diabetes and impaired glucose tolerance or prediabetes appeared with significantly high AGE levels in their eyes.

"The results of this preliminary study showed the lens autofluorescence is significantly greater in patients with prediabetes and type 2 diabetes, Mitra Tavakoli, lead researcher from the University of Exeter Medical School in England, said in a statement. The level of AGE products were correlated with the levels of blood sugar."

The findings support previous studies that suggested initial signs of diabetes may appear up to ten years before the disease starts to affect the body. Researchers of the latest study said their approach may give earlier detection, which increases the chance of preventing future complications.

"Lens autofluorescence could be a robust marker of long-term diabetes control predicting future complication risks, Tavakoli said. This supports the feasibility of non-invasive lens autofluorescence to screen subjects for undiagnosed type 2 diabetes and prediabetes subjects.

Researchers said the new approach to detecting diabetes earlier may also help reduce complications in people with type 2 diabetes because of timely intervention. However, they noted larger and long-term clinical studies are required to support their initial findings.

Related video: Diabetic Women More At Risk of Heart Failure Than Men (Provided by Veuer)

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Looking In Your Eyes May Help Predict Diabetes Development - msnNOW

WESTLAKE VILLAGE, Calif., Sept. 19, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ: MNKD) announced that data from a one-year study of Afrezza (insulin human) Inhalation Powder was presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.

Oral Abstract 183: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog

MannKind investigators reported data1 from more than 500 patients with type 1 diabetes comparing Afrezza to rapid-acting injected insulin analog (insulin aspart) therapy to assess glucose control, mealtime glucose changes, Afrezza dosing, and rates of hypoglycemia over a one-year period.

Oral Abstract Presentation Highlights:

Dr. Anne Peters, Clinical Professor of Medicine at the Keck School of Medicine at USC and Director of the USC Westside Center for Diabetes Care noted that the improved post-meal glucose levels and lower rates of low blood sugars seen in this study of individuals with type 1 diabetes support my growing clinical experience. The presentation of these data provides further evidence that proper dosing of Afrezza has the potential to safely and effectively keep more patients within the target glucose range at meal times.

These data provide additional evidence supporting the safe and effective use of Afrezza in type 1 diabetes patients and offer insight into the dosing of this ultra rapid-acting insulin as compared to a traditional rapid-acting injected insulin analog.

About AfrezzaAvailable by prescription, Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit http://www.afrezza.com.

About MannKind CorporationMannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only orally inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit http://www.mannkindcorp.com.

Forward-Looking StatementsThis press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKinds quarterly report on Form 10-Q for the quarter ended June 30, 2019 as well as MannKinds other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

MannKind Contact: Rose Alinaya Investor Relations 818-661-5000 ir@mannkindcorp.com

Appendix Presentation Information (1) Oral Presentation: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog Presenter: David M. Kendall, M.D. Presentation No: 183Date/Time: Thursday, September 19, 2019; 2:30 PM

Link:
MannKind Presents Positive Afrezza Clinical Data from Type 1 Diabetes Study at 55th Annual Meeting of the EASD - GlobeNewswire

Sanofi and Abbott, as well as Novo Nordisk and Medtronic, pair up, respectively, in order to work on a very similar, data-led approach, which is expected to facilitate disease monitoring and management.

Under the two separate collaborations, each pair of partners will work to connect their digital health products and integrate insulin dosing data collected by smart drug delivery devices with glucose monitoring, making the date visible concurrently on one software platform.

More specifically, in their joint project, Abbott and Sanofi will create a connected ecosystem, by synchronizing the formers FreeStyle Libre mobile app and cloud software with the latters smart insulin pens, apps and cloud software that are currently in development.

As a result, the partners expect to help patients and their healthcare providersmake more informed treatment decisions, a spokesperson for Abbott told us. The spokesperson adding that the technology will be made available within the next few years, pending local regulatory approvals.

On their side, Novo Nordisk and Medtronic announced plans to integrate insulin dosing data from smart insulin pens, which are currently being developed by Novo Nordisk, into continuous glucose monitoring (CGM) devices from Medtronic, such as the Guardian Connect system.

The partnership aims to help ease the hassle of diabetes management, said Camilla Sylvest, EVP of commercial strategy and corporate affairs at Novo Nordisk.

Following this agreement, the company now collaborates with all major CGM device producers, Sylvest added.

Novo Nordisk expects to launch its smart insulin pens, NovoPen 6 and NovoPen Echo Plus, which will be compatible with both Android and iOS devices, monitoring insulin dosage, in 2020. Following this commercialization, the Guardian Connect system will be updated to integrate data collected from these pens.

Enabling data sharing in between platforms is expected to help improve control and the quality of life decision cycle for patients through individualized glycemic management of diabetes, said Gustavo Pesquin, Sanofis SVP of global diabetes and cardiovascular franchise.

According to Abbott, managing diabetes on a daily basis requires the correlation of several types of data such as diet, insulin intake/dosing, and glucose levels. The digital ecosystem to be built will simplify users experience by consolidating these data, said the spokesperson for Abbott.

Alejandro Galindo, president of advanced insulin management division within the companys diabetes group, struck a similar note, when saying, We see incredible power in combining a variety of data points to drive [these] insights.

In order to improve diabetes treatment, Abbott says that the spotlight needs to be put on uniting the power of innovative technologies.

The future of diabetes care will be around integrating technologies to provide a deeper understanding of diabetes at the individual level and enablingpersonalized care, the spokesperson from Abbott told us.

This leads to better health outcomes and more meaningful conversations between doctor and patient, the spokesperson added.

The company plans to work on partnering with other diabetes and technology leaders as well, in order to reach smarter and more meaningful care, according to the spokesperson.

Originally posted here:
Future of diabetes care will be about data - In-PharmaTechnologist.com

One in every 11 people in the U.S. or more than 30 million Americans have diabetes, according to the American Diabetes Association. The number is expected to grow in the coming years since millions of people currently live with prediabetes.

Public health officials also estimated that there could be eight million adults who remain undiagnosed and unaware that they have diabetes. That is because in some cases symptoms of the condition may only appear in later stages.

When left untreated, the effects of diabetes can lead to serious health problems. The condition could increase the risk of coronary heart disease, pregnancy problems and vision loss, among others.

Hyperglycemia or high levels of blood sugar is the most common sign of diabetes and prediabetes. However, other symptoms may stay unnoticed for years even until the condition gets worse.

But it is important to know how to recognize changes in the body that may indicate diabetes. Early treatment or lifestyle changes could help reverse diabetes and prevent complications.

One study found that the adults who followed intensive lifestyle intervention reduced their risk of having diabetes by 58 percent. The effects of healthy lifestyle lasted at least 10 years after the study, according to DrAxe.com.

For people with type 1 diabetes, the symptoms include:

Type 2 diabetes may cause:

How To Control Diabetes Symptoms

Try Fasting

Researchers previously found that skipping breakfast could help manage glucose levels. A study in 2018 suggested that following a medically-supervised fasting could eliminate the need for insulin in people with type 2 diabetes.

Eat Healthy Diet

If you think you are not fit for the fasting method, simply adding healthy food options to your meals and removing products that provide less nutrients could also help reduce the effects of diabetes, such as vision problems.

Eating unprocessed, whole foods can help manage blood sugar levels. But you should avoid foods with high amounts of added sugars, trans fats, processed grains and starches.

Take Care of Your Skin

Diabetes increases bacterial, fungal and yeast infections. Having a good hygiene and treating skin naturally with essential oils could help manage some symptoms of the condition, such as chronically dry and itchy skin.

Moisturize daily using natural products and avoid too much exposure to the sun.

Manage Your Nutrient Intake

Some people with diabetes experience digestive issues. Taking digestive enzymes, probiotics and supplements could help improve gut health and control symptoms.

Improved nutrient intake may also address hormonal imbalances, sexual dysfunctions and trouble sleeping.

Alternate-day fasting (ADF) has been found offering a number of health benefits, from longer lifespan, reduced cholesterol levels to lower belly fat. Pixabay

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Common Diabetes Symptoms And What To Do About Them - Medical Daily

Two of the worlds largest companies in the diabetes space, Abbott and Sanofi, are partnering up to develop tools that integrate their respective blood sugar tracking and insulin delivery technologies.

The end goal is to create a connected device experience for people managing their diabetes, according to the two companies, through new smart insulin pens, smartphone apps for titration and cloud-based software analytics.

The nonexclusive collaboration will aim to combine Abbotts FreeStyle Libre continuous glucose monitoring system with Sanofis background in insulin dosing, into new, compatible devices being developed for regulatory approval within the coming years.

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Diabetes can be overwhelming as it is an information-rich condition with various streams of data from multiple devices, Abbott Diabetes Cares senior vice president Jared Watkin said in a statement.

Building a digital ecosystem around FreeStyle Libre simplifies the user experience by consolidating how people get their databoth through offering Abbotts digital health tools and by working with other diabetes and technology leaders, Watkin added.

The project will begin with gathering user consent to digitally connect and share data between Abbotts wearable blood sugar sensor and mobile app with Sanofis connected insulin pens and software, currently under development.

RELATED: Sanofi, boosted by partnerships, lays out connected tech ambitions in diabetes

"By partnering with Abbott, we are a step closer to realizing our connected ecosystem, which would help improve control and the quality of life decision cycle for patients through individualized glycemic management of diabetes, said Gustavo Pesquin, senior VP of Sanofis global diabetes and cardiovascular franchise.

Previously, Sanofi helped launch the virtual diabetes clinic Onduo through its joint venture with Verily. It aims to provide connected monitoring devices alongside personalized coaching and advice through a digital platform.

The Big Pharma has also been working with Verily and Sensile Medical to develop an all-in-one insulin patch and pump for patients with Type 2 diabetes. Meanwhile, Abbott has been working to make its FreeStyle Libre platform compatible with Novo Nordisks similarly connected delivery systems.

Link:
Abbott, Sanofi to interconnect their diabetes monitoring, insulin delivery tech - FierceBiotech

Chong Kun Dang said that it has presented a clinical trial result, which it said confirmed the superior metabolic syndrome improvement of Duvie, its diabetic treatment, in a direct comparison with MSD's Januvia.

The Korean company presented the results at the 2019 European Association for the Study of Diabetes held in Barcelona, Spain.

The study was a large-scale clinical trial participated in by 247 patients at 27 local institutions from January 2015 to October 2018, to confirm the effects of Duvie in improving metabolic syndrome. Duvie, the nation's 20th novel drug, is a Thiazolidinedione-class type 2 diabetes drug developed by Chong Kun Dang.

The research team, led by Professor Kim Doo-man at Kangdong Sacred Heart Hospital, randomly divided 247 patients with type-2 diabetes into two groups and administered either Duvie or Januvia for 24 weeks.

The results showed that there was no significant difference between the two groups regarding the hypoglycemic effect, which was the first endpoint. Also, the team confirmed similar results for the reduction rate of glycated hemoglobin and target reaching rate.

Regarding the proportion of patients with metabolic syndrome, which was the secondary endpoint, Duvie-treated group decreased their metabolic syndrome by 11.9 percent compared to Januvia-treated group's 4.8 percent.

The team also noted that the Duvie-administered group showed excellent effects on improving blood lipid levels such as triglyceride, high-density cholesterol, free fatty acid, and adiponectin.

There were no significant side effects in either group, and there was no significant difference in the incidence of adverse reactions such as weight gain and facial edema.

"The recent increase in the number of diabetic patients with metabolic syndrome makes the results of the study for Duvie significant," said Professor Kim Shin-gon at Korea University Anam Hospital, who participated in the study. "We expect Duvie will become a new treatment option that prevents complications in people with type 2 diabetes."

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Chong Kun Dang releases trial result for diabetes treatment - Korea Biomedical Review