A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec when Switching from Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults with Type 2 Diabetes

Start Date20 Jun 2024

Sponsor / Collaborator

Novo Nordisk India Pvt Ltd.

NCT06340854 / RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Start Date19 Apr 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT06288412 / RecruitingPhase 1

Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

Start Date26 Feb 2024

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Icodec Insulin

100 Translational Medicine associated with Icodec Insulin

100 Patents (Medical) associated with Icodec Insulin

Literatures (Medical) associated with Icodec Insulin

01 Feb 2024·Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists

Once-weekly Insulin Icodec as Compared to Once-daily Basal Insulins: A Meta-analysis

Article

Author: Mukhopadhyay, Pradip ; Sanyal, Debmalya ; Pandit, Kaushik ; Ghosh, Sujoy ; Chatterjee, Purushottam

BACKGROUND:

Once-weekly basal insulin icodec has been tested in clinical trials for efficacy and safety over currently available glargine-100 and degludec in different clinical settings for type 2 diabetes. We performed this meta-analysis to evaluate its overall safety and efficacy as compared to glargine-100 and degludec (nonicodec), from all available randomized controlled trials.

METHODS:

Seven trials comparing once-daily basal insulin analogs to once-weekly basal insulin icodec were included. Based on available information, outcomes in terms of HbA1c, fasting plasma glucose reduction, and increase in time in range (TIR) were compared. Side-effects were compared for overall hypoglycemia, severe hypoglycemia, and weight gain. The pooled effect size for continuously distributed data was measured as a reduction in "estimated differences in mean (with 95% CI)." For categorical data, the pooled effect size was measured as the Mantel-Haenszel risk ratio (with 95% CI).

RESULTS:

Analyzing against the nonicodec comparators together, the "estimated mean changes" in HbA1c and fasting plasma glucose favoring icodec were -0.22% (-0.35, -0.10) and -1.59 mg% (-9.26, 6.08) respectively. The "estimated mean increment" in weight for icodec was 0.64 kg (0.61, 0.67). The "estimated mean percentage" increment in TIR for icodec was 4.24% (2.99, 5.49). The Mantel-Haenszel risk ratios for all hypoglycemic events and severe hypoglycemia for icodec were 1.24 (1.02, 1.50) (P = .03) and 0.81 (0.31, 2.08) (P is not significant), respectively, suggesting a 24% increased incidence of all hypoglycemia with icodec.

CONCLUSION:

Once-weekly basal insulin icodec as compared to once-daily basal insulin analogs had a slight increase in the risk of overall hypoglycemia and weight gain, without any difference in severe hypoglycemia, with similar glycemic control (in terms of fasting plasma glucose, HbA1c, and TIR).

05 Jan 2024·Journal of the Endocrine Society

Once-weekly Insulin Icodec Versus Once-daily Long-acting Insulin for Type II Diabetes: A Meta-analysis of Randomized Controlled Trials

Review

Author: Elsaeidy, Ahmed Saad ; Abuelazm, Mohamed ; Amin, Ahmed Mazen ; Elzeftawy, Mohamad A ; Khlidj, Yehya ; Abdelazeem, Basel ; Ibrahim, Ahmed A ; Gowaily, Ibrahim ; Badr, Amr

Abstract:

Background:

Insulin icodec is a novel basal insulin analog with once-weekly subcutaneous administration. We aim to estimate the efficacy and safety of insulin icodec vs long-acting insulin (insulin glargine and degludec) in type II diabetic patients.

Methods:

We conducted a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching PubMed, Web of Science, SCOPUS, and Cochrane through May 29, 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD) with a 95% confidence interval (CI). Our primary outcome was glycated hemoglobin (HbA1C) change.

Results:

We included 7 RCTs with a total of 3183 patients. Insulin icodec was associated with significantly decreased HbA1C (MD: −0.15 with 95% CI [−0.24, −0.06], P = .002) and increased percentage of time with glucose in range (TIR) (MD: 4.06 with 95% CI [2.06, 6.06], P = .0001). However, insulin icodec was associated with increased body weight (MD: 0.57 with 95% CI [0.45, 0.70], P = .00001). Also, there was no difference regarding any serious adverse events (AEs) (RR: 0.96 with 95% CI [0.76, 1.20], P = .7) or AEs leading to withdrawal (RR: 1.54 with 95% CI [0.84, 2.82], P = .16). However, insulin icodec was associated with increased any AEs incidence (RR: 1.06 with 95% CI [1.01, 1.12], P = .02).

Conclusion:

Insulin icodec was associated with decreased HbA1C, increased TIR, with similar hypoglycemic and serious AEs. However, it was also associated with increased body weight and the incidence of any AEs.

01 Jan 2024·Annals of internal medicine

In T2DM requiring insulin initiation, icodec titrated with an app safely reduced HbA_1c vs. daily basal insulin analogues at 52 wk

Article

Author: Liakos, Aris ; Karagiannis, Thomas ; Tsapas, Apostolos

SOURCE CITATION:

Bajaj HS, Aberle J, Davies M, et al. Once-weekly insulin icodec with dosing guide app versus once-daily basal insulin analogues in insulin-naive type 2 diabetes (ONWARDS 5): a randomized trial. Ann Intern Med. 2023;176:1476-1485. 37748181.

News (Medical) associated with Icodec Insulin

22 Jun 2024

·www.prnewswire.com

Gan & Lee Pharmaceuticals Announces Significant Progress on New Diabetes and Obesity Treatments at the American Diabetes Association's 84th Scientific Sessions

BEIJING and BRIDGEWATER, N.J., June 22, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the results of the Phase 1b/2a clinical study of the Company's independently developed glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18 Injection, in an obese/overweight population in China, along with the results of two other innovative insulins' preclinical studies in poster presentations at the American Diabetes Association's（ADA's）84th Scientific Sessions. This randomized, double-blind, placebo-controlled, dose-escalation Phase 1b/2a clinical study evaluated the safety, tolerability, pharmacokinetics and efficacy of GZR18 Injection in Chinese subjects with obesity/overweight after multiple administration on a once-weekly (QW) or bi-weekly (Q2W) dosing interval. A total of 36 obese participants were enrolled in the study and randomized in a 3:1 ratio to receive a dose titration of 1.5 mg to 30 mg of GZR18 Injection or a matching placebo for a total of 35 weeks. The study results demonstrated a superior efficacy of GZR18 Injection than placebo for weight reduction in Chinese obese subjects. After 35 weeks of treatment, the mean weight change from baseline in the GZR18 QW group was -16.5 kg (95% CI: -19.9 kg, -13.1 kg); the placebo-adjusted mean percent weight change from baseline was -18.6% (95% CI: -25.5%, -11.6%). Although it was not a head-to-head study, when compared to the published data on weight reduction of similar products currently available on the market, GZR18's weight-reducing ability outperformed Semaglutide and dual-incretin receptor targeted Tirzepatide in similar study duration. Meanwhile, the mean weight change from baseline in the GZR18 Q2W group was -11.3 kg (95% CI: -15.4 kg, -7.2 kg); the placebo-adjusted mean percent weight change from baseline was -13.5% (95% CI: -21.0%, -6.0%). In addition, the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline were 100.0%, 90.0%, and 80.0%, respectively, in the GZR18 QW group, and the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline were 71.4%, 71.4%, and 42.9%, respectively, in the GZR18 Q2W group. No participant in the placebo group achieved a weight reduction of 5% and above. In terms of safety, GZR18 Injection was well tolerated in obese participants. The most commonly reported adverse events (AE) during treatment were gastrointestinal related AEs, and all were mild to moderate in severity. This is consistent with the incretin-based therapies approved for the treatment of obesity and overweight and occurred mainly in the early dose-escalation period. There were no serious hypoglycemic events in this study and no serious adverse events related to the investigational drug. Gan & Lee also announced that a multi-center, placebo-controlled, randomized, double-blind, 30-week Phase 2 clinical study evaluating the efficacy and safety of GZR18 Injection in Chinese adults with obesity and overweight is in progress. A total of 338 adults with obesity or overweight were enrolled in this study, and the study explores a broader dose range and frequency of administration. The main body of the Phase 2 has now been completed, and the priliminary study data further support the results of the reported Phase 1b/2a obese/overweight study, particularly the positive results achieved with bi-weekly dosing frequency. "We are very excited about the clinical results of the GZR18 program to the present day." Dr. Gan Zhong-ru, Founder of Gan & Lee, commented. "Our unique molecular design delays the onset of drug action and attenuates the peak effect, thereby improving drug tolerability and achieving smooth and sustained weight loss in a stepwise manner. Moreover, GZR18 has a longer duration of action, which is expected to be administered once every two weeks. Meanwhile, we hope that the clinical results of GZR18 will provide more evidence to reveal the mechanism of action of different targets of Incretins and Glucagon." In addition, Gan & Lee announced the results of preclinical trials of the company's investigational products: GZR4, a once-weekly insulin analog, and GZR101, a premixed dual insulin analog, at the ADA's 84th Scientific Sessions: Once-weekly Insulin Analog GZR4 GZR4 is a novel ultra-long-acting basal insulin analog designed for once-weekly administration. Results from preclinical studies have shown that GZR4 has a significantly higher affinity for human serum albumin (HSA) and a significantly lower affinity for the insulin receptor than insulin Icodec, another once-weekly insulin analog. Moreover, unlike insulin Icodec, GZR4 maintains its activity in activating the insulin receptor after binding to albumin. In the studies using animal models of diabetes, the glucose-lowering effect of GZR4 was observed to be 2-3 times greater than that of insulin Icodec. Based on the preclinical results, GZR4 is expected to be the fourth-generation basal insulin that can be administered once a week to achieve an effective glycemic control. Premixed Insulin Analog GZR101 GZR101 injection is a premixed insulin analog made from a combination of ultra-long-acting basal insulin GZR33 injection and rapid-acting insulin aspart (Rapilin®). Different from traditional premixed insulin analogs, the duration of glucose-lowering effect of basal insulin component (GZR33) in GZR101 can last 72 hours, and there is no significant peak within 24 hours after reaching a steady state with multiple injections. When combined with insulin aspart (Rapilin®️) to make a premixed insulin analog, it can achieve smooth control of fasting and postprandial blood glucose throughout the day. In diabetic animal models, GZR101 is significantly superior than insulin degludec/insulin aspart (IDegAsp) in blood glucose reduction and safety. As a premixed insulin analog developed based on an advanced concept, GZR101 is expected to make an important contribution to the control of blood glucose and the reduction of the risk of hypoglycemia in patients with diabetes globally. Conclusions and Future Directions The ADA's 84th scientific sessions highlighted Gan & Lee Pharmaceuticals' leadership in developing next-generation diabetes and obesity treatments. With these latest preclinical and clinical results, the Company will continue to advance the development of innovative therapeutics for diabetes. While ongoing studies and upcoming trials will further support the positive influence of these innovative medicines on public health issues related to diabetes and obesity. Forward-looking Statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. References ： American Diabetes Association. ADA's 84th Scientific Sessions. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®). In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked second overall and first among domestic companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. Further Information: [email protected] (Media) [email protected] (Business Development) SOURCE Gan & Lee Pharmaceuticals

Clinical ResultPhase 2Drug Approval

18 Jun 2024

·www.novonordisk.com

Novo Nordisk announces presentation of data from key semaglutide clinical trials in diabetes, obesity and chronic kidney disease at the 84th Scientific Sessions of the American Diabetes Association

FLOW kidney outcomes trial data evaluating efficacy and safety of once-weekly semaglutide 1.0 mg in people with type 2 diabetes 1 SELECT cardiovascular outcomes trial data evaluating efficacy and safety of once-weekly semaglutide 2.4 mg in people with obesity and established cardiovascular disease, without diabetes 2 STEP HFpEF trial programme data evaluating efficacy and safety of once-weekly semaglutide 2.4 mg in people with obesity-related heart failure with preserved ejection fraction (HFpEF), with and without diabetes 3 ,4 Bagsværd, Denmark, 18 June 2024 – Novo Nordisk today announced the presentation of 34 abstracts highlighting the breadth of its portfolio at the upcoming 84 th Scientific Sessions of the American Diabetes Association (ADA). The conference will be held in-person and virtually from 21–24 June 2024 in Orlando, US. Additional data from three landmark trials with semaglutide will also be presented in dedicated scientific sessions. The trials assess additional potential benefits of semaglutide, including evaluation of kidney and cardiovascular endpoints in people with type 2 diabetes and chronic kidney disease (FLOW, semaglutide 1.0 mg) and cardiovascular and glucose-related endpoints in people with obesity and CVD, with and without diabetes (SELECT and STEP HFpEF, semaglutide 2.4 mg). “We recognise that cardiometabolic conditions like cardiovascular disease, chronic kidney disease, obesity and type 2 diabetes are often interlinked and might occur in the same patient. We need to develop medicines that address multiple facets of the diseases,” said Stephen Gough, senior vice president and global chief medical officer at Novo Nordisk. “The broad data being presented this year at ADA reflect this goal. In particular, data from FLOW and SELECT look at ways to treat common comorbidities of diabetes and obesity, such as kidney disease and cardiovascular disease.” All abstracts will be published on the website of the journal Diabetes ® . Data from the scientific sessions will be made available after their presentation. Summary of presentations Scientific sessions The following data will be presented in the dedicated scientific sessions as a part of the scientific agenda of the congress: The first dedicated kidney outcome trial with a GLP1-RA once-weekly semaglutide – FLOW trial results (scientific session; 24 June, 13:30–15:00 EST) SELECT trial – New looks at glycemia, inflammation, and heart failure (scientific session; 22 June, 08:00–09:00 EST) The STEP-HFpEF and STEP-HFpEF-DM trials – Targeting obesity to treat heart failure (scientific session; 23 June, 16:30–18:00 EST) Poster and oral presentations The following abstracts were submitted by Novo Nordisk and are accepted for presentation at the congress: Diabetes Ozempic ® (once-weekly semaglutide 1.0 mg) Comparative effectiveness of semaglutide in T2D – year 2 results of a randomized pragmatic clinical trial (230-OR) Long-term effectiveness associated with maintenance doses of once-weekly semaglutide in US adults with poorly controlled T2D (766-P) Semaglutide in patients with peripheral arterial disease and type 2 diabetes: comorbidities and concomitant medications from the STRIDE trial (784-P) Real-world impact of once-weekly injectable semaglutide on weight, BMI and HbA 1c outcomes in type 2 diabetes: an observational study (PAUSE) (857-P) Real-World Impact of Once-Weekly Injectable Semaglutide (sema OW) vs. Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) on HbA1c, Weight, and Health Care Resource Utilization (HCRU) Outcomes in Type 2 Diabetes (T2D) - An Observational Study (PAUSE) (1884-LB) Rybelsus ® (once-daily oral semaglutide) Evaluating the efficacy of oral semaglutide in Chinese patients with T2D by baseline characteristics: post hoc analysis of PIONEER 11 and 12 (752-P) Real-world impact of fasting on adherence to dosing instructions and efficacy of oral semaglutide during Ramadan in people with type 2 diabetes: O-SEMA-Fast sub-analysis (808-P) CagriSema CagriSema improves insulin sensitivity in diet-induced obese rats (763-P) Once-weekly insulin icodec Healthcare resource utilization and costs with timely vs delayed basal insulin initiation (816-P) Demographic, clinical, and treatment characteristics of patients with timely vs. delayed basal insulin initiation (817-P) No evidence of increased physical activity-related hypoglycemia with once-weekly insulin icodec versus once-daily basal insulin in T1D: ONWARDS 6 (824-P) Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in individuals with T2D by kidney function: ONWARDS 1–5 (826-P) No evidence of increased physical activity-related hypoglycemia with once-weekly insulin icodec versus once-daily basal insulin in T2D: ONWARDS 1-5 (830-P) Adherence to app-based dose guidance for once-weekly insulin icodec in insulin-naive T2D: post hoc analysis of ONWARDS 5 (836-P) Impact of age on the efficacy and safety of once-weekly insulin icodec versus once-daily insulin in T2D (ONWARDS 1–5) (838-P) Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist use: ONWARDS 1–5 (840-P) Efficacy and safety of once-weekly insulin icodec vs once-daily basal insulin in T2D by ethnicity and race: ONWARDS 1–5 (841-P) Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes in Canada (1046-P) Efficacy and safety outcomes with once-weekly insulin icodec versus once-daily insulin degludec in T1D according to glycemic variability: ONWARDS 6 post hoc analysis (1882-LB) Daily insulins Influence of the functionally selective insulin analog NNC-965 on cardiac structure and function versus insulin glargine (IGla) (822-P) Improved glycemic control in people with type 2 diabetes (T2D) initiating or switching to insulin degludec/insulin aspart (IDegAsp) in a real-world setting in China (publication only) General diabetes Persistence and adherence of once weekly GLP-1 receptor agonists in patients with type 2 diabetes and atherosclerotic cardiovascular disease in a real-world setting (740-P) Impact of newer GLP-1 RAs on HbA1c in US adults with type 2 diabetes: a population-level time-series analysis (774-P) Understanding attitudes about basal insulin: insights from a global survey of people with type 2 diabetes (833-P) The value of the guideline-recommended management of type 2 diabetes: A novel population-level system dynamics approach (1040-P) Prevalence of atherosclerotic cardiovascular diseases in adults with type 2 diabetes in Jordan: the PACT-MEA Study (1789-LB) In vivo chain-splitting of human insulin (2032-LB) Digital Health Improvement in time in range after smart insulin pen initiation in Austria (842-P) Multinational analysis of factors associated with missed bolus insulin injections using smart pen data (843-P) Obesity Wegovy ® (once-weekly semaglutide 2.4 mg) CONCRETE – characterization of patients receiving telemedicine and branded antiobesity medication for medical weight management: a retrospective analysis (1684-P) Clinical outcomes in patients with obesity or overweight treated with semaglutide 2.4 mg: a real-world retrospective cohort study in the United States (SCOPE 2) (1691-P) Modeling the Impact of Semaglutide 2.4 mg in U.S. Patients with Atherosclerotic Cardiovascular Disease and BMI ≥27 kg/m2 (1981-LB) General obesity Patient-centered weight management clinical decision support: a proof-of-concept study (1101-P) Prevalence, characteristics, and clinical burden among patients with overweight or obesity and established ASCVD in a US real world setting (1692-P) About Ozempic ® Once-weekly subcutaneous semaglutide is approved in 0.5 mg, 1.0 mg and 2.0 mg doses under the brand name Ozempic ® and indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease. About Rybelsus ® Oral semaglutide is administered once daily and is approved for use in three therapeutic doses, 3 mg, 7 mg and 14 mg under the brand name Rybelsus ® . It is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise. About Wegovy ® Once-weekly subcutaneous semaglutide 2.4 mg is approved under the brand name Wegovy ® and is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in adults and paediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 66,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information Media: Ambre James-Brown +45 3079 9289 abmo@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com Investors: Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com David Heiberg Landsted +45 3077 6915 dhel@novonordisk.com Sina Meyer +45 3079 6656 azey@novonordisk.com Frederik Taylor Pitter +45 3075 8259 fptr@novonordisk.com Ida Melvold Gjøsund +45 3077 5649 idmg@novonordisk.com Mark Joseph Root (US) +1 848 213 3219 mjhr@novonordisk.com _______________________ References 1. ClinicalTrials.gov. A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW). Available at: https://clinicaltrials.gov/study/NCT03819153. Last accessed: June 2024. 2. ClinicalTrials.gov. Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT). Available athttps://clinicaltrials.gov/study/NCT03574597. Last accessed: June 2024. 3. ClinicalTrials.gov. Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity (STEP-HFpEF). Available at: https://clinicaltrials.gov/study/NCT04788511. Last accessed: June 2024. 4. ClinicalTrials.gov. Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM). Available at: https://clinicaltrials.gov/study/ NCT04916470. Last accessed: June 2024. Attachment PR240618-ADA_Global Curtain raiser

Drug ApprovalClinical ResultClinical Study

28 May 2024

·www.biopharmadive.com

Roche’s Sabry retires; Duchenne drug fails confirmatory test

BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line!Today, a brief rundown of news from Merck & Co. and biotechnology startup Cartography Biosciences, as well as updates from Roche, Novartis, Novo Nordisk and Nippon Shinyaku that you may have missed over the holiday weekend.Merck & Co.s drug Keytruda helped people with a hard-to-treat form of breast cancer live longer when used first as a neoadjuvant, or preoperative, therapy, and then as an adjuvant therapy. The study, called Keynote-522, compared Keytruda- and chemotherapy-based regimens to neoadjuvant chemo alone in early-stage triple-negative breast cancer thats considered high risk. Merck, which won U.S. approval for the regimen in July 2021 based on earlier data, said Tuesday the improvement in survival was statistically significant and clinically meaningful. Ned PagliaruloCartography Biosciences will receive $20 million from Gilead Sciences in a research collaboration to discover drug targets for cancers of the breast and lungs. Cartography, which raised $57 million in a Series A venture financing two years ago, touts a pair of computational and genomics platforms that it says can map novel tumor-selective antigens. Ned PagliaruloJames Sabry, who has led pharma partnering for Roche, is retiring after fourteen years with the Swiss drugmaker, the company said Monday. He will be replaced by Boris Zatra, who will on July 1 become head of group business development, a new role that combines several dealmaking functions.Zatra will report to Roche CEO Thomas Schinecker as part of an enlarged executive committee. Ned PagliaruloPreliminary results from a confirmatory clinical trial of Nippon Shinyakus Viltepso for Duchenne muscular dystrophy showed treatment didnt lead to a meaningful benefit over a placebo. The study, which enrolled 77 boys with Duchenne who could still walk, measured the time it took participants to stand from lying down. After 48 weeks, both groups showed a trend of increased velocity from baseline, with no statistically significant difference between them. The study was meant to confirm Viltepsos accelerated approval, which the Food and Drug Administration granted in 2020. Nippon Shinyaku said it is conducting further analyses of the results and working closely with regulators. Ned PagliaruloNovartis on Monday announced positive Phase 3 results for two kidney disease drugs its developing. One, called atrasentan and acquired through a buyout of Chinook Therapeutics, significantly reduced protein in urine compared to a placebo among people with a rare condition known as IgA nephropathy. The other, an approved medicine Novartis sells as Fabhalta, also lowered proteinuria versus placebo in treating C3 glomerulopathy, an even less common disease. Proteinuria reduction is considered a surrogate marker of benefit in certain kidney conditions, and Novartis plans to submit both drugs for regulatory approvals in IgA nephropathy and C3 glomerulopathy, respectively. Ned PagliaruloA panel of FDA advisers voted 7-4 against recommending approval of a weekly insulin injection from Novo Nordisk in people with Type 1 diabetes, according to Reuters. The shot, called insulin icodec, could offer a more convenient alternative than current daily insulin injections. But FDA staff flagged a higher rate of hypoglycemia in participants given Novos experimental drug in testing, compared to those who received a comparator treatment. The agency usually, though not always,follows its advisers recommendations. In Europe, regulators recently authorized insulin icodec for sale there. Ned Pagliarulo '

Clinical ResultPhase 3Drug ApprovalExecutive Change

100 Deals associated with Icodec Insulin

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	CN	Novo Nordisk A/S	18 Jun 2024
Diabetes Mellitus	EU	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	IS	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	LI	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	NO	Novo Nordisk A/S	17 May 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	US	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	JP	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	AT	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	CA	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	DE	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	IN	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	IT	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	NL	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	RU	Novo Nordisk A/S	30 Apr 2021
Diabetes Mellitus, Type 1	Phase 3	ES	Novo Nordisk A/S	30 Apr 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04460885 (ONWARDS 1, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 insulin-naïve	492	Once-weekly insulin icodec	krapfictbb(abgodxfsvh) = TBR <54 mg/dL was not significantly different between arms agcjbxgrxv (myhmqokmvt ) View more	Positive	03 Oct 2023
NCT04880850 \| NCT04770532 \| NCT04460885 \| NCT04795531 \| NCT04848480 \| NCT04760626 (ONWARDS 1-6, EASD2023)	Phase 3	-	-	Once-weekly insulin icodec	hufrolpqqp(hhxwrjlfwn) = eyhxugdgzf hohyekjarm (txzohfbjby, 1.1)	Positive	03 Oct 2023
NCT04795531 (ONWARDS 3, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	588	Insulin icodec	xzconrbsih(xfyqiookqp): P-Value = <0.0001 View more	Positive	03 Oct 2023
				Insulin degludec
NCT04760626 (ONWARDS 5, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	-	Once-weekly insulin icodec with a dosing guide app	vsxopsuqbi(xtuqqemiza): P-Value = <0.0001 View more	Positive	03 Oct 2023
				Once-daily basal insulin analogues (degludec, glargine U100 or glargine U300)
NCT04848480 (ONWARDS 6, EASD2023)	Phase 3	Diabetes Mellitus, Type 1	582	Insulin icodec	rbcjblibbr(rlpeovkuas) = voxqzfxofu yddabkipac (egouytnini ) View more	Negative	03 Oct 2023
				Insulin degludec	rbcjblibbr(rlpeovkuas) = yizbhenmqs yddabkipac (egouytnini ) View more
NCT04795531 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	588	Once-weekly insulin icodec	swihvkahgg(gqdlhyokaw) = ppeykegzyf rjduewgdhc (pnmoqdakcy ) View more	Positive	24 Jun 2023
				Once-daily insulin degludec	swihvkahgg(gqdlhyokaw) = dlqcrucjix rjduewgdhc (pnmoqdakcy ) View more
ONWARDS 5 (ADA2023)	Not Applicable	Diabetes Mellitus, Type 2	-	Once-Weekly Insulin Icodec with a Dosing Guide App	lvimpgfjti(txbzxulxrb) = sgzamagxvc wllzuwhvjk (vsjsltkofj )	Positive	20 Jun 2023
				Once-Daily Basal Insulin Analogs (degludec, glargine U100 or glargine U300)	lvimpgfjti(txbzxulxrb) = lgvdqthham wllzuwhvjk (vsjsltkofj )
NCT03945656 (Pubmed)	Phase 1	Diabetes Mellitus, Type 2	43	Once-weekly insulin icodec	mtmgnyzgqh(cvcxwlgrth) = qdyzyyxfvm onfshalqxc (hkzzccqmbx )	-	13 Jun 2023
				Once-daily insulin glargine U100	mtmgnyzgqh(cvcxwlgrth) = wujxibepgh onfshalqxc (hkzzccqmbx )
NCT04770532 (ONWARDS 2, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	526	Icodec Insulin	poyolndxnk(tdjnkqyayg) = eefzkknqjv uabwwaeede (nsbkbpddkq ) View more	Non-inferior	22 Sep 2022
				Insulin degludec	poyolndxnk(tdjnkqyayg) = oarwhnmvlu uabwwaeede (nsbkbpddkq ) View more
EASD2022	Phase 2	Diabetes Mellitus, Type 2	606	Insulin icodec	ykqiauoiih(kdbrzggndv) = Only 1 hypoglycemia level 3 event was noted (patient on icodec) hnnvfuembb (orgfejohzu )	Positive	20 Sep 2022

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