Basal Insulin Peglispro Studies Demonstrate Superiority to Insulin Glargine Across Multiple Measures in People with Type 1 Diabetes






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INDIANAPOLIS, June 6, 2015 /PRNewswire/ — In newly released Phase III trial data, Eli Lilly and Company’s (NYSE: LLY) basal insulin peglispro (BIL) demonstrated statistically significantly lower hemoglobin A1c (HbA1c) compared to insulin glargine at 2six and 52 weeks in individuals along with type 1 diabetes. Detailed results from the IMAGINE-1 and IMAGINE-3 clinical trials were presented today at the American Diabetes Association’s (ADA) 75th Scientific Sessions in Boston.1,2 individuals along with type 1 diabetes in these trials were additionally taking mealtime insulin.1,2

BIL has actually a hepato-preferential activity profile derived from its low effect in peripheral tissue, making it much more similar to endogenous insulin compared to others exogenous insulins along with a conventional activity profile.

“In several individuals along with type 1 diabetes, current insulin treatments may not be optimal for a variety of reasons,” said Melanie Davies, M.D., professor of diabetes medicine, University of Leicester, United Kingdom. “Results from the IMAGINE trials showed that BIL has actually a unique combination of benefits, including superior glycemic control, low nocturnal hypoglycemia and weight loss, all of which could be beneficial for individuals that need basal insulin treatment.”

In IMAGINE-1 and IMAGINE-3, BIL demonstrated superiority in HbA1c compared to insulin glargine.1,2 Significantly much more patients taking BIL met the ADA’s recommended HbA1c target of much less compared to 7 percent and suffered lower rates of nocturnal hypoglycemia compared to those taking insulin glargine.3 In both trials – in which patients were taking both mealtime and basal insulin – there was a statistically substantial increase in the rate of total hypoglycemia for patients taking BIL compared along with those taking insulin glargine because of a better rate of daytime hypoglycemic events.1,2

In both trials, patients treated along with BIL suffered mean weight-loss compared to weight gain in patients that took insulin glargine.1,2

In both trials, patients taking BIL had an increase in triglycerides compared to insulin glargine. In IMAGINE-3, patients taking BIL had an increase in LDL cholesterol, a decrease in HDL cholesterol levels and enhances in systolic and diastolic blood stress compared to insulin glargine. The rate of major side cardiac events MACE+ (cardiovascular death, non-fatal stroke, non-fatal MI and hospitalization because of unstable angina) was lower for patients taking BIL compared along with those taking insulin glargine in IMAGINE-3. There were no MACE+ events in IMAGINE-1.

Additionally, in both studies, patients taking BIL had an increase in the liver enzyme ALT (alanine aminotransferase). Four weeks after BIL was discontinued these levels decreased toward baseline. Liver fat was measured by MRI in a subset of patients in both studies and was better in patients treated along with BIL compared to insulin glargine.1,2

“These unprecedented results are meaningful not only to individuals along with type 1 diabetes however additionally for those in the scientific and clinical community,” said David Kendall, M.D., vice president, Medical Affairs, Lilly Diabetes. “Lilly is committed to producing innovative treatments to suggestions individuals along with diabetes achieve their goals. To that end, we are excited to keep on development of promising investigational treatments such as BIL.”

Lilly additionally presented results from IMAGINE-7, a study investigating flexible dose-timing of BIL in individuals along with type 1 diabetes. There was no statistically substantial difference in HbA1c or nocturnal and total hypoglycemia rates between individuals taking BIL dosed at variable times throughout the day.4

BIL Type 1 Clinical Data

BIL showed consistency in various measurements of glucose control across type 1 diabetes trials:1,2

  • Patients taking BIL showed lower HbA1c at the primary endpoints compared to those on insulin glargine in the IMAGINE-1 trial at 2six weeks (7.1 percent vs. 7.4 percent) and in the IMAGINE-3 trial at 52 weeks (7.4 percent vs. 7.six percent).1,2
  • Significantly much more patients taking BIL reached the ADA’s recommended target HbA1c of much less compared to 7 percent compared to insulin glargine in the IMAGINE-1 trial at the primary endpoint of 2six weeks (44.9 percent vs. 27.5 percent) and in the IMAGINE-3 trial at the 52- week primary endpoint (35.3 percent vs. 26.1 percent).1,2

BIL low the risk of nocturnal hypoglycemia in type 1 trials:1,2

  • In both studies, patients taking BIL had lower rates of nocturnal hypoglycemia compared to insulin glargine:

    • IMAGINE-1 at 26-week primary endpoint: 1.7 vs. 2.7 events/patient/30 days
    • IMAGINE-3 at 52-week primary endpoint: 1.3 vs. 2.5 events/patient/30 days.1,2

BIL showed better rates of total hypoglycemia:

  • Patients taking BIL had better rates of total hypoglycemia compared to insulin glargine in IMAGINE-1 at the 26-week primary endpoint (16.0 vs. 12.4 events/patient/30 days) and in IMAGINE-3 at the 52-week primary endpoint (15.3 vs. 13.9 events/patient/30 days).1,2
  • In an integrated analysis of IMAGINE-1 and IMAGINE-3, there were no substantial differences in rates of severe hypoglycemia between BIL and insulin glargine. However, patients taking BIL had better rates of severe hypoglycemia compared to insulin glargine in IMAGINE-1 at 2six weeks (39.0 vs. 16.2 events/100 patient years) and similar rates of severe hypoglycemia compared to insulin glargine in IMAGINE-3 at 52 weeks (19.7 vs. 22.5 events/100 patient years).1,2

BIL showed consistent weight-loss in type 1 trials:1,2

  • Patients taking BIL suffered mean weight-loss while patients taking insulin glargine suffered mean weight gain in both IMAGINE-1 at the primary endpoint of 2six weeks (-1.2 kg vs. +0.7 kg) and IMAGINE-3 at the primary endpoint of 52 weeks (-0.six kg vs. +1.2 kg).1,2

Hepatic (liver) safety findings:

  • In an integrated analysis of type 1 studies, patients taking BIL had a mean increase in the liver enzyme ALT compared to insulin glargine (the mean difference between treatment groups at 52 weeks was 7.2 IU/L). Four weeks after BIL was discontinued these levels decreased toward baseline. Additionally, much more BIL-treated patients had an ALT level higher compared to or equal to three times the upper limit of normal compared to insulin glargine (ALT ≥ 3X ULN: 4.4 percent vs. 1.5 percent). No cases of severe drug-induced liver injury (Hy’s Law) occurred in these studies.1,2
  • Liver fat was measured using magnetic resonance imaging (MRI) in a subset of patients from both studies. Results showed BIL-treated patients had an increase in liver fat content from baseline compared to those treated along with insulin glargine (the mean difference between treatment groups was 2.2 percent at 52 weeks).1,2
  • In the IMAGINE-7 trial, patients taking BIL suffered an increase in the level of ALT from baseline (10.59 IU/L), however four weeks after BIL was discontinued these levels decreased toward baseline. No patients met the criteria for severe drug-induced liver injury (Hy’s Law) in the study.4

Non-hepatic safety findings:

  • In both IMAGINE-1 and IMAGINE-3, patients taking BIL had an increase in triglycerides.
  • An analysis across all trials – including type 2 – showed that the rates of major side cardiovascular events among patients taking BIL and those taking insulin glargine or NPH insulin were similar, along with an observed hazard ratio below 1 and the upper limit of the 95 percent assurance interval below 1.4.
  • In IMAGINE-3, BIL-treated patients suffered small however statistically substantial enhances in systolic and diastolic blood stress compared to insulin glargine patients (much less compared to 2 mmHg mean difference at 52 weeks).
  • In IMAGINE-3, patients on BIL additionally had enhances in LDL cholesterol levels levels and reductions in HDL cholesterol levels levels compared to those taking insulin glargine.2
  • There were significantly much more injection site reactions in patients treated along with BIL compared to those treated along with insulin glargine.1,2

About the Studies
IMAGINE-1
IMAGINE-1 is a Phase III, 78-week (primary endpoint at 2six weeks), open-label, randomized, study of 455 patients designed to compare BIL (n=295) to insulin glargine (n=160) in combination along with mealtime insulin in patients along with type 1 diabetes. Patients were randomized to bedtime BIL (n=295) or insulin glargine (n=160). Patients in both groups had a mean baseline HbA1c of 7.8 percent.1

IMAGINE-3
IMAGINE-3 is a Phase III, 52-week, double-blind, randomized study of 1,114 patients along with type 1 diabetes designed to compare BIL (n=664) to insulin glargine (n=450) in combination along with mealtime insulin. Patients in both groups had a mean baseline HbA1c of 7.9 percent.2

IMAGINE-7
IMAGINE-7 is a Phase III, 36-week, randomized, crossover study of 212 patients designed to compare BIL administered once day-to-day at a fixed time to BIL administered at a variable time of day in patients along with type 1 diabetes. Patients were randomized to two 12-week treatment periods comparing fixed time dosing to variable time dosing. Patients had a mean baseline HbA1c of 7.5 percent. 4

About Basal Insulin Peglispro
Basal insulin peglispro, discovered in Lilly Research Laboratories, is currently in Phase III clinical trials and is being studied as a once-day-to-day treatment for type 1 and type 2 diabetes. BIL is a hepato-preferential basal insulin. Its activity profile is derived from its low effect in peripheral tissue, making it much more similar to endogenous insulin compared to others exogenous insulins along with a conventional activity profile.    

In the clinical trial program to date, consisting of much more compared to 6,000 patients, approximately 3,900 patients have actually been treated along with BIL. In the core Phase III clinical trial program consisting of seven IMAGINE trials in patients along with type 1 and type 2 diabetes, superiority in HbA1c was seen in 5 trials for BIL versus energetic comparators.

About Diabetes
Approximately 29 million Americans5 and an estimated 387 million individuals global have actually type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.  Diabetes is a chronic disease that occurs once the physique either does not properly produce, or use, the hormone insulin.6

About Lilly Diabetes
Lilly has actually been a global leader in diabetes care since 1923, once we introduced the world’s very first commercial insulin. Today we are building upon this heritage by working to meet the diverse calls for of individuals along with diabetes and those that care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to offer real solutions—from medicines to support programs and more—we strive to make life much better for all those affected by diabetes around the world. For much more information, visit www.lillydiabetes.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring along with discovery to make life much better for individuals around the world. We were founded much more compared to a century ago by a man committed to producing high-quality medicines that meet real needs, and today we continue to be true to that mission in all our work. Across the globe, Lilly employees job to find and bring life-changing medicines to those that need them, improve the understanding and management of disease, and offer spine to communities through philanthropy and volunteerism. To learn much more Regarding Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

P-LLY

 

This press release contains forward-looking statements Regarding an investigational compound basal insulin peglispro, which is currently in development for the treatment of diabetes. It reflects Lilly’s current beliefs; however, as along with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no make certain that future study results and patient experience will certainly be consistent along with study findings to date or that basal insulin peglispro will certainly receive called for regulatory approvals or prove to be commercially successful. For further discussion of these and others risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed along with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

1 Garg S, Hideaki J, Dreyer M, et al. higher HbA1c Reduction along with Basal Insulin Peglispro (BIL) v Insulin Glargine (GL) in an Open-label, Randomized Study in T1D Patients 9 (pts): IMAGINE 1. Abstract 95-OR.  Presented at 75th American Diabetes Association (ADA) Scientific Sessions; 3 Standards of Medical Care in Diabetes. Diabetes Care. 6 Worldwide Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: Worldwide Diabetes Federation, 2014. http://www.idf.org/diabetesatlas/update-2014.

 

Refer to: Candace Johnson, johnson_candace_a@lilly.com, (317) 755-9143

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Evaluating Cosmetic Dentistry In Arizona

The importance of a healthy, bright smile is hard to overestimate. Clean, bright teeth indicate excellent health, and smiles are interpreted positively the globe over. Any person that has actually seen a “makeover” fact prove to has actually seen exactly what an enormous difference a excellent smile makes to a person’s look and their confidence. Arizona dentistry in general and cosmetic dentistry in particular has actually advanced significantly in recent years.

Perhaps the original “cosmetic dentistry” was dentures. Yet dentures are not merely cosmetic. Evaluating good cosmetic dentistry requires a careful eye like that possessed by a Scottsdale, Arizona dentist who has been practicing his craft for years.. A decent set of dentures can easily make the difference between a healthy and balanced personal that is able to consume a healthy and balanced diet regimen and an harmful personal whose diet regimen is quite limited.

Another process that falls somewhat in to the category of “cosmetic” dentistry is orthodontics, typically known as “braces.” Again, there are a lot of cases in which braces are vital for a healthy and balanced mouth. quite crowded teeth are difficult to preserve clean and can easily therefore decay much more easily. Large overbites, underbites, and crossbites make chewing difficult and can easily make it difficult to eat a great lot of healthy and balanced foods.

Many people grab braces solely to have actually a much more beautiful smile, and they can easily make an enormous difference in a person’s overall appearance. The assurance that comes from having cosmetic dentistry can easily do wonders for a person’s appearance as well.

One of the newest types of cosmetic dentistry is teeth whitening. It started out as a system of custom mouth trays containing hydrogen peroxide gel that came residence from the dentist along with the patient and took several days or weeks to complete. Now the in-office procedures just take an hr or so, and over the counter whitening products can easily lighten teeth by several shades. They have actually come to be fairly inexpensive, too, starting at about $15 to $20.

Cosmetic dentistry encompasses a lot of dental procedures, several of which have actually overall good health incentives as well.

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S1 Biopharma Supports FDA Advisory Committee’s Recommendation to Approve the First-Ever Treatment for Hypoactive Sexual Desire Disorder






NEW YORK, June 5, 2015 /PRNewswire/ — Yesterday’s FDA Advisory Committee recommendation for the approval of flibanserin was a landmark step for women’s health, addressing the essential unmet medical necessity for women living along with hypoactive sexual impulse disorder, or HSDD. We are especially happy for S1 Biopharma’s Dr. Robert Pyke that fathered flibanserin at Boehringer Ingelheim prior to it was acquired by Sprout Pharmaceuticals. Dr. Pyke joined S1 Biopharma as Chief Medical Officer in 2012 to create our next-generation drug for HSDD, Lorexys.

HSDD is a medical condition marked by a lack of sexual thoughts and impulse for sexual activity that cannot be accounted for by yet another medical, physical, or psychiatric condition, or medication. An estimated 1 in 10 women could have actually HSDD gradually in their life, for which therapies love flibanserin along with a 9%- 13% responder fee over placebo, and S1 Biopharma’s very first in class, next-generation drug Lorexys have actually been created to address.

S1 Biopharma is currently planning for upcoming Phase IIb studies for Lorexys for the treatment of HSDD. In its recently completed Phase IIa study, Lorexys demonstrated a 76% responder fee that was 38% better compared to control.

About S1 Biopharma

S1 Biopharma is a developer of first-in-class drugs for sexual dysfunction in the 2 women and men. The company’s pipeline of therapies is non-hormonal, acting on the sexual centers of the mind by restoring the natural balance of essential neurotransmitters. S1 Biopharma’s pipeline utilizes its trademark philosophy of recognizing and combining mechanistically opposing agents that job synergistically to optimize practical effects on sexual function while minimizing edge effects. The company’s lead compound, Lorexys, recently completed a Phase IIa clinical trial for the treatment of hypoactive sexual impulse disorder (HSDD).

For a lot more guide please visit www.s1biopharma.com.

Contact:
John Kaufmann
info@s1biopharma.com

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Biodefense Panel Expresses Grave Concerns over Findings at Nation’s Research Labs



WASHINGTON, June 4, 2015 /PRNewswire/ — Today, the co-chairs of the Blue Ribbon Study Panel on Biodefense responded to recent events involving U.S. high-degree biocontainment labs and USA Today’s investigative report in to these labs. The co-chairs expressed grave pertains to over the findings of lax safety standards and called on the federal government to strengthen the nation’s lab biosecurity.



“The state of oversight of U.S. biological research labs is very troubling,” said Joe Lieberman, former senator and co-chair of the Blue Ribbon Study Panel on Biodefense. “Every day, labs across America job along with dangerous biological pathogens. Yet several state governments don’t already know concerning them, let alone have actually contingency plans for as soon as these ailment agents escape.”


The USA Today report found several shortcomings in the United States’ research labs — especially those handling the most dangerous pathogens. These labs lack important oversight. Their failures and security breaches are frequently hidden from the public — also as the government.



There are hundreds of labs functioning along with deadly pathogens across the nation. several of these have actually been cited by government agencies for significant failures in biosafety. And yet, insufficient funding, limited transparency, and unsatisfactory coordination have actually left all of in demand of considerable improvements.



The report’s findings are only the most up to date indication that the United States is not taking the biological threat as seriously as it should. The release of this report comes merely days after a military research lab in Utah unintentionally sent live samples of anthrax to labs across the United States and overseas.



“This report highlights a a lot larger weakness in biodefense policy,” said Tom Ridge, former Homeland Security Secretary and co-chair of the Blue Ribbon Panel. “It is difficult enough to identify exactly what bio threats our enemies might be making overseas. So we should make certain that we strengthen federal biosecurity policy to reduce the risk of bioterrorism, biological warfare, and the ailment and death caused by devastating outbreaks at Residence and abroad.”



About the Blue Ribbon Study Panel on Biodefense
The Blue Ribbon Study Panel on Biodefense will certainly identify and recommend modifications to U.S. policy and law to strengthen national biodefense while optimizing resource investments. The Panel will certainly create a report that will: (1) assess ongoing efforts; (2) articulate actions to enhance the Nation’s ability to prevent, deter, intend for, detect, respond to, attribute, recover from, and mitigate biological and large-scale chemical incidents; and (3) identify near and long term actions by current and future Congresses and Presidential Administrations. The Report of the Blue Ribbon Study Panel on Biodefense will certainly be issued in Fall 2015.



The panel is co-chaired by former Sen. Joe Lieberman and former Gov. Tom Ridge. Others members contain former Secretary of Healthiness and Human Services Donna Shalala, former Sen. Tom Daschle, former Rep. Jim Greenwood, and the Hon. Kenneth Wainstein.



MEDIA CONTACT:
Spencer Caton
(202) 471-4228 ext. 112
Email





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