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Bagsvrd, Denmark, 22 September 2020 Today, Novo Nordisk announced results from three phase 2 clinical trials for insulin icodec, an investigational once-weekly basal insulin analogue, which were presented during the 56th European Association for the Study of Diabetes (EASD) Annual Meeting 2020.

The first showed that switching to insulin icodec from other basal insulins using two different switch approaches was efficacious and well-tolerated compared to once-daily insulin glargine U100 and the switching approaches were without an increased risk of clinically significant or severe hypoglycaemic episodes compared to once-daily insulin glargine U100.1 This 16-week phase 2 clinical trial involved 154 adults with type 2 diabetes inadequately controlled with oral antidiabetic drugs and once/twice-daily basal insulin randomised to once-weekly insulin icodec with or without a loading dose or insulin glargine U100.1,2 The primary endpoint of the trial, the blood sugar time in range 3.910.0 mmol/L during weeks 15 and 16, showed that people receiving insulin icodec with a loading dose demonstrated a significantly greater time in range compared to insulin glargine U100 (73% vs 65%, respectively). People who received insulin icodec without a loading dose demonstrated similar blood sugar time in range compared to insulin glargine U100 (66% vs 65%, respectively).1

We know that many people with type 2 diabetes prefer simplicity, meaning fewer injections and more convenience than what is currently provided with once- or twice-daily basal insulin treatment regimens, said Dr Harpreet Bajaj, lead trial investigator and endocrinologist, LMC Diabetes & Endocrinology, Ontario, Canada. This phase 2 trial demonstrates the potential benefit insulin icodec could offer to people with type 2 diabetes in need of insulin therapy, aiding easy transition onto a new treatment option without the daily burden and complexity that is associated with current therapies and potentially even experience more time in good glycaemic control with low risk of hypoglycaemia.

Key secondary endpoints included changes from baseline in HbA1c, which were not statistically significantly different for icodec with and without a loading dose compared to insulin glargine U100 (0.77, 0.47 and 0.54 % points, respectively). Rates of clinically significant or severe hypoglycaemic episodes, also known as a hypo or low blood sugar, were similar between insulin icodec with a loading dose and insulin glargine U100 (observed rates of level 2 [<3mmol/L] and 3 [severe] hypoglycaemia were 0.78 and 0.79 events per patient year of exposure for insulin icodec and insulin glargine U100, respectively), and numerically lower for insulin icodec without a loading dose (0.15 events per patient year of exposure). No new safety issues were identified in relation to once-weekly insulin icodec and no severe episodes occurred in this trial.1

Data comparing the effect of different titration algorithms of insulin icodec with insulin glargine U100 to better understand the optimal titration for a once-weekly basal insulin in people with type 2 diabetes who were inadequately controlled with oral antidiabetics were also presented at the meeting. In this 16-week trial, all three once-weekly titration algorithms for insulin icodec investigated were shown to be well-tolerated and efficacious, and demonstrated an improved or similar time in range versus once-daily insulin glargine U100, depending on the titration algorithm applied.3,4

Results from the 26-week phase 2 clinical trial in insulin-nave adults with type 2 diabetes where insulin icodec demonstrated comparable blood sugar lowering and a similar safety profile to once-daily insulin glargine U100 were also presented at the EASD Annual Meeting and simultaneously published in the New England Journal of Medicine.5,6 The data were previously presented at the 80th Scientific Sessions of the American Diabetes Association in June 2020.7

As a leader in diabetes innovation, Novo Nordisk understands that there is a need to continue to offer innovative treatment options to support people living with diabetes and improve outcomes, said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. We are excited by the phase 2 data that have been presented at EASD 2020 and ADA 2020 for insulin icodec, which demonstrated its efficacy and tolerability, and has the potential to offer a simplified treatment option for people with type 2 diabetes initiating insulin treatment, as well as the option for those to switch.

The phase 2 trials will inform the trial designs for the phase 3 clinical development programme for once-weekly insulin icodec, which Novo Nordisk will initiate later in 2020.

For more news and media materials from Novo Nordisk at EASD 2020, please visit: https://www.epresspack.net/novonordiskEASD2020/phase-2-once-weekly-insulin

About the phase 2 switching trial

This 16-week, randomised, open label, treat-to-target, phase 2 trial compared the efficacy and safety of once-weekly insulin icodec with and without a loading dose versus once-daily insulin glargine U100* in 154 people with type 2 diabetes inadequately controlled (HbA1c 7.010.0%) with oral antidiabetic drugs and once/twice-daily insulin. A unit to unit switch (or a 20% reduction for those receiving twice-daily basal insulin or insulin glargine U300 prior to randomisation) with and without an initial 100% loading dose of insulin icodec was investigated compared to insulin glargine U100. Insulin doses were titrated weekly based on the lowest (if below target) or the mean of 3 pre-breakfast self-measured blood glucose values to a target of 4.47.2 mmol/L. The primary endpoint was time in range 3.910.0 mmol/L (70180 mg/dL) based on continuous glucose monitoring (Dexcom G6, Dexcom Inc, CA, USA) during weeks 15 and 16. Secondary endpoints included HbA1c and body weight changes from baseline to week16, weekly insulin dose during weeks 15 and 16, and hypoglycaemic episodes.1,2

About insulin icodec

Insulin icodec is an investigational, long-acting basal insulin analogue with a half-life of approximately one week.8 Once injected, insulin icodec binds strongly but reversibly to albumin. This results in a continuous, slow and steady release of active icodec to achieve effective lowering of blood sugar throughout the week. The injection volume of once-weekly insulin icodec is equivalent to daily insulin glargine U100 due to the concentrated formulation.9

About Novo NordiskNovo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 43,500 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Further information

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*NCT03922750: A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine

References

1. Bajaj HS, Isendahl J, Gowda A, et al. Efficacy and Safety of Switching to Insulin Icodec, a Once-Weekly Basal Insulin, vs Insulin Glargine U100 in Patients with T2D Inadequately Controlled on OADs and Basal Insulin. Abstract 657. Presented at the 56th European Association for the Study of Diabetes (EASD) Annual Meeting 2020, The impact of new basal insulins, 12:00-13:00 CEST on 22 September 2020.2. ClinicalTrials.gov. A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine. Available at: https://clinicaltrials.gov/ct2/show/NCT03922750. Last accessed: September 2020.3. Lingvay I, Koefoed MM, Stachlewska K, et al. Effect of Three Different Titration Algorithms of Insulin Icodec vs Insulin Glargine U100 on Time in Range in Patients with T2D Inadequately Controlled on OADs. Abstract 658. Presented at the virtual 56th European Association for the Study of Diabetes (EASD) Annual Meeting 2020, The impact of new basal insulins, 12:00-13:00 CEST on 22 September 2020.4. ClinicalTrials.gov. A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before. Available at: https://clinicaltrials.gov/ct2/show/NCT03951805. Last accessed: September 2020.5. Rosenstock J, Kjrsgaard MIS, Mller DV, et al. Once-Weekly Basal Insulin Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine U100 in Insulin Nave Patients with T2D Inadequately Controlled on OADs. Abstract 56. Presented at the virtual 56th European Association for the Study of Diabetes Annual Meeting 2020, Developing better insulins, 14:45-15:00 CEST on 22 September 2020.6. Rosenstock J, Bajaj HS, Janez A, et al. Once-Weekly Insulin for Type 2 Diabetes Without Previous Insulin Treatment. New England Journal of Medicine. 2020; Published online ahead of print; DOI: 10.1056/NEJMoa2022474. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2022474.7. Rosenstock J, Kjrsgaard MIS, Mller DV, et al. Once-Weekly Basal Insulin Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine U100 in Insulin Nave Patients with T2D Inadequately Controlled on OADs. Abstract 238-OR. Presented at the 80th Scientific Sessions of the Virtual American Diabetes Association Annual Meeting, Insulin Therapies, 18:15-18:30 CDT on 14 June 2020.8. Hvelmann U, Brndsted L, Kristensen NR. et al. Insulin Icodec: An Insulin Analog Suited for Once-Weekly Dosing in Type 2 Diabetes. Abstract 237-OR. Presented at the 80th Scientific Sessions of the American Diabetes Association, Insulin Therapies, 18:00-18:15 CDT on 14 June 2020.9. Nishimura E, Kjeldsen T, Hublek F, et al. Molecular and Biological Properties of Insulin Icodec, a New Insulin Analog Designed to Give a Long Half-Life Suitable for Once-Weekly Dosing. Abstract 236-OR. 80th Scientific Sessions of the American Diabetes Association; Insulin Therapies, 17:45-18:00 CDT on 14 June 2020.

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Switching to investigational once-weekly insulin icodec from other basal insulins demonstrated to be efficacious and well-tolerated for people with...

OTTAWA, Sept. 22, 2020 (GLOBE NEWSWIRE) -- NAV CANADA today made the difficult decision to eliminate permanent jobs as the COVID-19 pandemic continues to have a significant negative impact on global air traffic and on the aviation industry. To adapt to the new realities of air traffic levels, the company is also taking steps to safely streamline operations and will be launching level of service reviews for certain aerodromes.

Prior to the COVID-19 pandemic, the company had 5,100 employees nationwide. Including the previous reduction in staffing of temporary employees in the spring and early retirements, the company has reduced more than 720 jobs or 14 per cent of the workforce. NAV CANADA will continue to monitor air traffic activity across the country and adapt its operations and workforce accordingly as necessary.

Undoubtedly, the company is in the midst of the toughest moment in its history. NAV CANADA is not immune to the economic downturn and severe financial impacts the aviation industry is experiencing, said Neil Wilson, President and CEO.

Cost containment strategies commenced as soon as the pandemic was declared. Prior to todays layoffs, NAV CANADA reduced management compensation, deferred retroactive wage increases with bargaining units and offered a voluntary retirement program to minimize cash outflows. NAV CANADA has also benefited from the Canadian Emergency Wage Subsidy program.

NAV CANADA is working closely with labour unions to adapt the size of its workforce in response to the persisting low air traffic levels. The cuts are across all departments and include most of the current cohort of operational students.

The company will also close its flight information centres in Winnipeg and Halifax. Pilots and dispatchers will continue to receive the same vital information they need, including flight-planning services, in-depth interpretive weather information and en-route flight information, which will be provided by the remaining flight information centres. Air traffic services will not be impacted by this change.

NAV CANADA must continue to fulfill its commitment to efficiently run Canadas air navigation system, ensuring that the services supplied align with market demands. In the coming weeks, aeronautical studies will be launched for multiple aerodromes to assess the level of service required to provide safe and efficient operations for our airline, air cargo and general aviation customers.

Aeronautical studies apply a safety-focused and Transport Canada regulated process, which NAV CANADA has followed in support of its globally recognized safety record for more than 20 years. This rigorous, systematic approach provides for full consultation with all affected stakeholders, with the key factor being safety.

The aviation industry is contracting and faces profound changes. We continue to monitor the impact of the pandemic and will continue to take steps as they are necessary to align service with traffic levels while maintaining the integrity of the air navigation system, said Neil Wilson, President and CEO.

Todays changes will not have any operational impact on the safe delivery of air navigation services across the country.

Quick Facts

About NAV CANADA

NAV CANADA is a private, not-for-profit company, established in 1996, providing air traffic control, airport advisory services, weather briefings and aeronautical information services for more than 18 million square kilometres of Canadian domestic and international airspace.

The Company is internationally recognized for its safety record, and technology innovation. Air traffic management systems developed by NAV CANADA are used by air navigation service providers in countries worldwide.

For further information, please contact:

Brian BoudreauManager, Media Relations

media@navcanada.caMedia Information Line: 1-888-562-8226

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NAV CANADA announces workforce reductions and looks to streamline operations - GlobeNewswire

KUALA LUMPUR (THE STAR/ASIA NEWS NETWORK) - Malaysia's construction industry suffered RM18.5 billion (S$6.1 billion) in losses during the first three phases of the country's lockdownto curb the spread of the coronavirus, Works Minister Fadillah Yusof said on Tuesday (Sep 22).

The first and second phases of the movement control order (MCO) between March 18 and April 14 led to RM11.6 billion in industry losses.

The Works Minister said RM6.9 billion in losses were recorded between April 15 and April 28 in the third phase of the MCO which saw the gradual reopening of 13 sub-sectors.

The first three phases of the MCO lasted for 47 days.

"The most severe impact was caused by financial issues, project deliveries and workforce limitations," Datuk Seri Fadillah said in a speech to industry players.

Under the first three phases, all work were ordered to stop unless they were deemed essential services like medicine shops and medical facilities and supermarkets. Restaurants could only do takeout orders.

All construction works from railway projects to home renovations stopped.

With the disease seen as being under control in Malaysia, the country from May 4 reopened some sectors of the economy under the so-called Conditional MCO, and relaxed controls on some social functions from June 10 under the Recovery MCO.

Mr Fadillah said inspections on 7,590 construction sites nationwide by the Construction Industry Development Board (CIDB) from April 20 to Sept 20 found that 1.96 per cent had not resumed operation.

He said 149 sites were still temporarily closed, with 45 of them facing financial issues, among other reasons.

According to Mr Fadillah, some leeway or special considerations were given by banks to developers affected by the Covid-19 pandemic.

He also said that 89,708 or 88.7 per cent of all construction companies registered with CIDB were class G1 to G5, or categorised as small and medium enterprises.

Many had a high dependence on foreign labour with 438,264 workers, and there was low adoption of technology.

"There has also been a failure to obtain funding from financial institutions for projects affected by Covid-19," he said.

Mr Fadillah, together with Minister in the Prime Minister's Department (Economic Affairs) Mustapa Mohamed, had an engagement session on Tuesday with industry players from the construction sector, to get feedback on the impact of the pandemic.

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Malaysia's construction industry records $6b losses in first three lockdown phases - The Straits Times

A robot that carries out nasal swabbing to diagnose Covid-19 has been developed by clinicians who say the automated procedure is safer, faster and more comfortable compared with manual swab tests.

Although other countries have developed similar robots, the clinicians said this bot, called SwabBot, is the first that allows patients to fully control the swab process so they are more comfortable.

A patient sits in front of the robot while holding on to the handhold, and latches his nostril onto the disposable nosepiece.

After using his chin to push a button and activate the bot, the nosepiece moves slightly upwards to widen the nostril. The swab will extend and rotate safely and gently through the patient's nose to the back of the nasal cavity.

SwabBot has a built-in feature that withdraws the swab stick if there is resistance when it is moved deeper into the nasal cavity. If patients feel uncomfortable at any point, they can stop the process by moving their head away from the robot.

The process takes 20 seconds, while a manual swab test can take twice as long. At the end of the procedure, a medical worker will open the machine to remove and store the swab stick.

The robot, including its interior, will be wiped down and covered with a fresh plastic drape fitted with a nosepiece for the next patient.

The machine, which is 35cm by 40cm, and 49cm high, was developed by clinicians from the National Cancer Centre Singapore (NCCS), Singapore General Hospital (SGH) and Duke-NUS Medical School, in collaboration with medical robotics company Biobot Surgical.

The team said the robot can address the limitations and risks of manual swabbing. It reduces swabbers' risk of exposure to the virus and the need for training people, standardises the consistency of swabs taken, and increases the efficiency of conducting swab tests.

"Our team felt that we had to find a better way to swab patients to reduce the risk of exposure of Covid-19 to our healthcare workers, especially when patients sneeze or cough during the swabbing process," said principal investigator Rena Dharmawan, associate consultant, head and neck surgery, at NCCS and SGH's Division of Surgery and Surgical Oncology.

Beyond that, the clinicians wanted to make the swabbing procedure more comfortable for patients.

SwabBot retains the same gentle touch and precision as surgeons who perform very delicate procedures, said Dr Luke Tay, consultant at SGH's Department of Vascular Surgery, who is one of the project's team members.

Dr Dharmawan said: "When patients are empowered and fully in control of the swabbing process, they are mentally prepared and experience subjectively less pain."

To date, a total of 85 patients from SGH and Bright Vision Hospital as well as volunteers have participated in the ongoing clinical trial that compares SwabBot against manual swabbing. All of the participants said the procedure with the robot was either equally or less painful compared with getting a manual swab, said Dr Dharmawan.

Volunteer Marco Lizwan, 25, a second-year medical student at Duke-NUS Medical School, said he was less worried when he was swabbed by the robot.

"I found the robot more comfortable because you can (turn it on) whenever you are ready. So things are within your control. I was worried when I did the manual one because I was wondering if the swabber's hand will be shaky."

SingHealth and Biobot Surgical have filed a patent for SwabBot's technology. Biobot is also working to get the robot CE-marked for it to be commercialised globally.

Two months ago, a Taiwanese medtech firm developed a robotic arm that can conduct nasal swabs by using a depth-sensing camera. A start-up in Denmark also recently invented a fully automated throat swab robot.

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Safer, faster Covid-19 tests with Singapore robot swabber - The Straits Times

PARIS (REUTERS) - Global airlines called on Tuesday for airport Covid-19 tests for all departing international passengers to replace the quarantines they blame for exacerbating the travel slump.

Rapid and affordable antigen tests that can be administered by non-medical staff are expected to become available in coming weeks and should be rolled out under globally agreed standards, the head of the International Air Transport Association (IATA) said during an online media briefing.

We dont see any alternative solution that would be less challenging or more effective, IATA director-general Alexandre de Juniac said.

Airlines hammered by the pandemic are pressing governments to embrace alternatives to blanket travel restrictions that are still hampering a traffic recovery and now tightening again in Europe amid resurgent case numbers.

With rapid antigen tests becoming available for as little as US$7 (S$9) each, De Juniac said, airlines will push for their use to be endorsed by International Civil Aviation Organisation (ICAO), the UN agency that oversees global aviation rules.

IATA believes production could be quickly increased to millions per day and the tests phased in between late October and the end of the year, helping to save a part of the winter season, De Juniac told Reuters television.

A global agreement is needed to ensure pre-departure test results are uniformly accepted by the destination country, he said. It will also boost passenger confidence that everybody on the aircraft has been tested.

The airlines position has evolved with the test technology.

IATA argued a month ago for new rules to recognise lab-based PCR tests conducted 48 hours before departure.

Last-minute airport screening is more effective because it seals off the system against forged certificates or infections contracted just before travel, De Juniac said on Tuesday.

Antigen tests are faster but less sensitive and therefore slightly more likely to miss positive cases than the PCR alternatives, although the accuracy gap has narrowed.

Among companies marketing the new tests, German diagnostics specialist Qiagen said earlier this month it planned to launch a Covid-19 antigen test that provided results in 15 minutes and could be deployed in airports or stadiums.

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Airlines call for Covid-19 tests before all international flights - The Straits Times