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Monday, June 10, 2019

ADA: Insulet sees gains in Type 1 diabetes with tubeless insulin pump in children

nsulet presented new data evaluating the use of its tubeless, closed-loop Omnipod insulin management system in young children with Type 1 diabetes.
Using an investigational version of the device, 14 children between the ages of two and six were supervised for over a week in a hotel to simulate the unique challenges of an at-home setting for this age group.
Following seven days of standard therapy with continuous glucose monitoring, the participants entered a two- to three-day treatment phase using the Omnipod’s personalized, predictive algorithms. During this second phase, meals were not restricted, and boluses were given according to the patient’s usual routine. Additionally, the participants exercised for more than 30 minutes per day.
Over a 24-hour period, average blood glucose levels were significantly lower during treatment with the closed-loop Omnipod device, with patients spending 32% more time in range. Similarly low glucose levels were seen overnight, while the patients slept, with 47% more time spent in range.

According to Insulet, the safety and performance of its Omnipod system was similar to that observed in older pediatric, adolescent and adult study participants. One severe hypoglycemic event was reported following exercise, which was treated with oral carbohydrates.

The results were presented at the annual Scientific Sessions of the American Diabetes Association in San Francisco alongside additional abstracts examining Insulet’s tubeless Omnipod device, including the real-world treatment patterns of thousands of adult and pediatric users as well as its use in combination with Glooko’s cloud-based diabetes data platform.
An observational study of more than 9,900 young pediatric and adolescent patients with Type 1 diabetes saw frequent bolusing with the Omnipod system and Glooko software, 5.3 times per day on average among users between the ages of 12 and 18. Between ages six and 11, that number increased to 6.4, and up to 7.5 among children under age six. Overall, the youth cohort data showed that blood glucose levels with a tubeless insulin pump compared favorably to those seen in larger Type 1 diabetes registries, the company said.
Similar results were seen in a separate analysis of about 8,000 adults with Type 1 diabetes with an average age of 40.8. There was an average of 4.7 bolus deliveries per day, with an average amount of 4.5 units of insulin each.
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Sunday, June 9, 2019

Big global study: Diabetes med cuts cardiovascular and kidney problems

A clinical trial that followed more than 9,900 people in 24 countries has found that the drug dulaglutide reduced cardiovascular events and kidney problems in middle-aged and older people with Type 2 diabetes.
During more than five years of follow-up, cardiovascular events like heart attacks and strokes were reduced by 12% in people taking dulaglutide compared to people taking a placebo. This effect was seen in both men and women with or without previous cardiovascular disease.
In addition, during the same period, the drug reduced the development of kidney disease by 15%.
The trial was led by the Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences. Two papers describing the cardiovascular and kidney results of the trial were published today in the journal The Lancet from the study called the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial.
“Compared to others, people with diabetes have twice the rate of cardiovascular events like heart attacks and strokes, and up to 40% of people with diabetes develop kidney disease,” said Hertzel C. Gerstein, principal investigator for the study, professor of medicine at McMaster and deputy director of the PHRI.
“The REWIND trial shows that dulaglutide can safely reduce these events while improving diabetes control and modestly lowering weight and blood pressure in middle-aged people with Type 2 diabetes.”
Nearly one in five people over the age of 60 have diabetes and most have Type 2 diabetes. Altogether, nearly ten per cent of adults are living with diabetes, including 425 million people worldwide; 100 million in the U.S., and three million people in Canada.
Dulaglutide is a glucagon-like peptide-1 receptor agonist that is injected once per week. It is approved for glucose lowering and works by helping the pancreas release the right amount of insulin when blood sugar levels are high, slowing the emptying of the stomach after a meal, and reducing appetite and weight.
Gerstein pointed out the trial participants were very similar to the sorts of people with diabetes who are seen in medical practice. Participants were followed for a median of 5.4 years, much longer than previous trials, and more than 46 per cent of participants were women. Less than a third of participants had previous cardiovascular disease.
The drug was well tolerated, modestly reduced weight, low-density lipoprotein (LDL) cholesterol and blood pressure, and modestly increased heart rate. Gastrointestinal side effects including constipation or diarrhea were reported more frequently in participants taking dulaglutide (47%) compared to placebo (34%).
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The REWIND trial was funded by Eli Lilly and Company, the makers of the dulaglutide drug Trulicity. The study was designed and led by a team of scientists that included representatives of the funder. The data were analyzed by scientists of the PHRI and the principal investigator had final responsibility for the papers.
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Lilly’s ultra rapid lispro provided similar A1C reductions compared to Humalog

Two phase 3 studies show that Eli Lilly and Company’s (NYSE: LLY) ultra rapid lispro (URLi) provided non-inferior A1C reductions compared to Humalog® (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog.1,2 Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day.3 URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels. These data and several other studies were presented at the American Diabetes Association’s®79th Scientific Sessions®.
The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when the insulins were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and two hours (-31.2 mg/dL [T1D] and -17.4 mg/dL [T2D]) after a test meal compared to Humalog.1,2
Hypoglycemia is the most common adverse reaction associated with insulin. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.1,2
‘Many people taking mealtime insulin are not meeting their A1C goals while also experiencing high blood glucose levels after eating. This may create worry about their ability to achieve good control,’ said Bruce Bode, MD, FACE, diabetes specialist at Atlanta Diabetes Associates.4 ‘The results from these two studies suggest that URLi may help control blood glucose after meals, as well as help people reach A1C goals.’
The PRONTO studies were designed as treat-to-target, which enables clinicians to determine differences in other important treatment effects – such as rates of hypoglycemia, post-meal glucose control and glucose time in range – at the same level of glycemic control. A sub-set of participants in PRONTO-T1D were evaluated using blinded continuous glucose monitoring to provide more complete information on daily blood glucose patterns. At 26 weeks, URLi demonstrated a significantly better blood glucose profile up to four hours after breakfast compared to Humalog. The study further showed that URLi had significantly longer (+43.6 minutes) time in range (71-180 mg/dL) during the day and similar time in range during the night compared to Humalog.3
Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also demonstrated URLi’s effect on post-meal blood glucose control. Results showed URLi was absorbed significantly faster into the blood stream compared to Humalog, insulin aspart and fast-acting insulin aspart. URLi also showed lower blood glucose spikes after a test meal compared to the insulins tested, which was significant compared to Humalog and insulin aspart. Additionally, the early blood glucose profile with URLi closely matched that of participants without diabetes.5
‘We’re developing URLi to provide a mealtime insulin option that more closely mirrors the way insulin works in people without diabetes,’ said Tom Hardy, MD, PhD, senior medical director at Lilly. ‘If approved, URLi will offer a new mealtime insulin option that, in clinical trials, showed similar A1C reductions to Humalog with significant improvements in post-meal blood glucose after a test meal.’
Lilly submitted applications for URLi with regulatory authorities in Europe and Japan and plans to submit in the U.S. later this year.
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PG&E Shuts Power to California Resort Area to Prevent Wildfires

PG&E Corp. turned off power to more than 17,000 customers in Northern California this weekend as part of the first wave of what the utility has said will likely be numerous pre-emptive shutdowns this year to help prevent deadly wildfires.
It came after the National Weather Service issued its first red-flag warning, which signals high fire danger, of 2019 for a region that has until now been mostly cool and moist.
About 1,600 businesses and homes in parts of Napa, Yolo and Solano counties, located about 75 miles northeast of San Francisco lost power from 6 a.m. Saturday morning until late that night.
Also Saturday night, PG&E shut off power to an additional 16,000 customers in Butte and Yuba counties, including the town of Paradise, which was destroyed by the Camp Fire last year. That blackout was still ongoing Sunday.
Paradise resident Robert Broome, who weathered the Camp Fire inside his home after unsuccessfully trying to evacuate, said Saturday night’s outage was inconvenient but better than another deadly blaze. “It’s what they should have done last time and they didn’t,” the online radio host said Sunday from his house, where the power went out at about 9 p.m. the previous evening.
The San Francisco-based company earlier this year announced its plan to become the first utility in the U.S. to intentionally shut off power to help prevent its transmission equipment from igniting a fire. PG&E owns and operates thousands of miles of power lines that snake through tinder-dry forests and brush and has said its equipment likely sparked the 153,000-acre Camp Fire last November, killing 85 people. California officials have since verified PG&E’s culpability.
State records show PG&E equipment has caused hundreds of other fires in recent years. The company filed for bankruptcy protection in January to protect itself from wildfire-related liability.
PG&E warned Friday afternoon that the Napa County resort town of Lake Berryessa might be among the areas to face blackouts this weekend. Nonetheless, Saturday morning’s shutdown came as an unpleasant wake-up call to the boat shops and other businesses that cater to crowds of people visiting the 16-mile-long reservoir perched in a rugged mountain.
“This is better than having a fire, but it definitely makes it difficult, ” Josh Grimstad, manager of Lake Berryessa Boat & Jet Ski Rentals, said that morning in a dark office with no working phones and a long line of customers.
An office assistant retrieved reservations from a desktop computer powered by a portable generator too weak to provide energy to much else. Most customers took the inconvenience in stride, although 45-year-old Gabriel Garcia grumbled that PG&E was doing too little too late.
“Now they’re taking all these precautions,” said Mr. Garcia, a carpenter from Napa who was renting a WaveRunner boat to ride with his 8-year-old son. “They didn’t before all of these fires.”
Other people praised PG&E for taking precautionary steps.
“If we can get adjusted to these outages, it’s worth it, because these fires just kill business,” said Mike Medina, co-owner of the 55-site Spanish Flat Campground along Lake Berryessa.
Mr. Medina and two partners struggled Saturday to load about a dozen empty gasoline containers onto a pickup truck so they could get fuel to keep a generator running. The campground needs power in part to keep 200 bags of ice worth about $1,000 from melting, they said.
PG&E previously warned that in such shutdowns, electricity wouldn’t be restored for at least 24 hours and possibly days longer until crews can inspect power lines for any damage.
“We understand people without power is an inconvenience, but we are doing this for the safety of the communities,” said Paul Moreno, a spokesman for the utility.
The Turtle Rock Bar & Cafe — a popular biker haunt with dollar bills festooning to the ceiling — sat just outside the blackout area. Owner Pete Leung said he invested in a $20,000 generator last December, believing that power outages would become more commonplace in the region. Two years ago, the business barely escaped the flames of a wildfire, which left a trail of dead trees on all sides.
“They’re going to cut your power now, that’s the new norm,” Mr. Leung said.
His home atop a nearby ridge did have its electricity turned off on Saturday, prompting Mr. Leung to do what more residents are doing: fire up an emergency generator. But with the 8,000-watt generator consuming five gallons of gasoline every eight hours, he said it could get expensive if the shutdown lasts too long.
“They don’t tell you when they’re going to turn the power back on, and that’s the hard part,” Mr. Leung, 42, said Saturday afternoon as he tossed a ball in his backyard for his Labrador retriever, Sammy.
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Tandem Diabetes Care Reports Positive Results of 2 Insulin Pump Studies

Significant Time-in-Range Improvements Demonstrated in Adult and Pediatric Age Groups
Tandem Diabetes Care, Inc. (TNDM), a leading insulin delivery and diabetes technology company, today announced positive results from two studies of the t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed-loop technology. Data from both studies demonstrated that the system achieved the primary outcome of increasing time in range (70-180 mg/dL) without any severe hypoglycemic events. The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring (CGM) sensor values to predict glucose levels and adjust insulin delivery to prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices.
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MannKind Presents Positive Afrezza Data of 3 Studies at American Diabetes Assn

MannKind Corporation (Nasdaq: MNKD) announced that new data from three different studies of Afrezza® (insulin human) Inhalation Powder were released at the American Diabetes Association’s 79th Scientific Sessions, being held June 7-11, in San Francisco, California.
Poster 1350-P:   Safety and Pharmacokinetics of Technosphere Insulin in Pediatric Patients
MannKind will present a poster with initial information from its ongoing study of Safety and Pharmacokinetics of Technosphere Insulin (Afrezza) in Pediatric Patients ¹ on Monday, June 10.  This study is the first step in preparation for a phase 3 safety and efficacy study.
Poster Highlights:                         
  • In pediatric patients, the rapid rise in insulin concentrations corresponded with early postprandial glucose control within the first hour post-dose. The profile is similar to that previously observed in adults.
  • Consistent with its safety profile in adults, Afrezza was generally well-tolerated in pediatric patients; most treatment emergent adverse events were of mild severity, and no severe hypoglycemia was observed.
  • These data will help guide the finalization of the protocol for a phase 3 safety and efficacy study.
“We are excited to share the progress of the ongoing pediatric study program,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating as quickly as possible the potential use of Afrezza in children and adolescents as an option for mealtime insulin therapy is a top priority for MannKind.”
Poster 136-LB:   Effective Treatment of T2D Patients Uncontrolled on Multiple Diabetes Medications by Adding Afrezza® Mealtime Ultra-Rapid Insulin
Dr. Philip Levin and colleagues presented data from an independent study supported and funded by MannKind. Dr. Levin presented late-breaking clinical data on interim results of a study² showing how a fixed titration schedule can be implemented to achieve better time in range and reduction of overall A1c.
Late Breaking Poster Highlights:
  • Enrolled adult patients with uncontrolled type 2 diabetes on two or more therapies (orals/ basal/ GLPs) – with the addition of Afrezza at all meals by means of a rapid and ongoing titration protocol
  • Observed a mean decrease in A1c of ~1.6% (all subjects with A1c reduction over 12 weeks of study)
  • 93% (13 of 14 subjects) achieved A1c below 8% (mean baseline A1c 9.1%)
  • Reduced hyperglycemia (>250mg/dL) by 74%
  • Increased time in range more than 75%; daily glucose decreased by ~50 mg/dL as measured by blinded continuous glucose monitoring
  • No significant difference in rates of hypoglycemia with the addition of Afrezza
“We are pleased to share the interim analysis from our independent investigator-initiated trial of Afrezza therapy. These preliminary data significantly advance our understanding of the potential clinical benefits and practical use of Afrezza therapy for those living with type 2 diabetes,” stated Philip Levin, M.D. of Bay West Endocrinology Associates and MODEL Clinical Research in Baltimore, MD. “Data generated to this point are encouraging and support the use of Afrezza as prandial therapy earlier in the treatment of type 2 diabetes.”
Oral Abstract 
151-OR: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog
MannKind investigators also shared data at an oral presentation³ using mixed meal tolerance testing to assess glucose control, Afrezza dosing and overall safety in a cohort of individuals with type 1 diabetes.
Oral Presentation Highlights:
  • When compared to rapid acting injected insulin, Afrezza provided significantly better glucose control in the first two hours following the meal.
  • Even when adjusting the dose of Afrezza using up to two times the dose of injected insulin aspart, Afrezza treatment was associated with lower rates of overall and level 2 hypoglycemia – an observation that was particularly evident in the late (>2 hour) post-meal period.
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Single Course of Provention PRV-031 Delays Type 1 Diabetes Onset in High-Risk

Provention Bio, Inc. (Nasdaq:PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that results from the National Institutes of Health (NIH)-sponsored “At-Risk” Study were published on-line in The New England Journal of Medicine and presented at the Scientific Sessions of the 79th Annual American Diabetes Association (ADA) meeting.  The “At-Risk” Study was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with additional support from JDRF. The study was conducted by the Type 1 Diabetes TrialNet, an international collaboration aimed at discovering ways to delay or prevent type 1 diabetes (T1D), and evaluated Provention’s PRV-031 (teplizumab) for the prevention or delay of clinical T1D in relatives of type 1 diabetics at high-risk of developing the disease.  PRV-031 (teplizumab) is an anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D.
The “At Risk” Study enrolled 76 participants ages 8 to 49 who were “At-Risk” because they had two or more T1D autoantibodies and abnormal glucose metabolism (dysglycemia); 72% of participants were under the age of 18.  Subjects were randomized to receive either PRV-031 (teplizumab) or placebo.
Results from the study showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of clinical T1D, as compared to placebo, by a median of 2 years in children and adults considered to be at high risk. The median time to clinical diagnosis of T1D for placebo participants was just over 24 months.  In comparison, the median time for PRV-031 (teplizumab)-treated participants to clinical diagnosis of T1D was just over 48 months (p=0.006). During the trial, 72% in the placebo group developed clinical diabetes compared to only 43% of the PRV-031 (teplizumab) group. PRV-031 (teplizumab) was well tolerated and the safety data were consistent with prior studies in newly diagnosed patients.
“This groundbreaking study demonstrates that we can use immunotherapy, specifically PRV-031 (teplizumab), to prevent or significantly delay the onset of clinical type 1 diabetes by at least two years in individuals who will almost certainly progress to clinical disease,” said Dr. Eleanor Ramos, Provention’s Chief Medical Officer and Chief Operating Officer.  “More importantly, approximately 60% of subjects in the study did not develop T1D following only one course of PRV-031 therapy, double the placebo group. Teplizumab is the first immune modulator to show a delay in the clinical onset of type 1 diabetes.”
Dr. Kevan Herold, M.D., Professor of Immunobiology and Medicine at Yale University, lead author of the study, stated, “These results have real clinical meaning for individuals at-risk of developing clinical type 1 diabetes such as family members of patients. Delaying the onset of clinical T1D may mean the disease burden could be postponed to a point at which patients are better able to manage their disease such as after infancy, elementary school, high school or even college. With PRV-031 (teplizumab), we may now be able to intervene and fundamentally change the progression of T1D for these at-risk subjects. In addition, we look forward to learning more as we observe patients during the study’s follow-up period, which will also evaluate the long-term outcomes for those in whom the diagnosis of disease has been delayed to see if they will be diagnosed with T1D or are protected.”
Conference Call and Webcast Information
Provention Bio will discuss these results via conference call on Monday, June 10, 2019 at 8:30 AM ET. A webcast presentation will also be available on the Investors page of the Company’s website, www.proventionbio.com.  To access the call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) five minutes prior to the start time and ask to be connected to the “Provention Bio Call”. A webcast replay of the call will be available beginning at 11:00 AM ET on the day of the call.
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