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

NCT06370715 / RecruitingPhase 4

A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India

The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.
The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

Start Date18 Apr 2024

Sponsor / Collaborator

Eli Lilly & Co.

[+1]

NCT06178874 / Not yet recruitingNot ApplicableIIT

Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia

The role of ultralong insulin in the control of the blood glucose level in diabetic patients is well known, the current study will discuss the role of ultralong insulin in controlling of hyperglycaemia in critical illness defined as failure or impending failure of an organ

Start Date01 Dec 2023

Sponsor / Collaborator

Ain Shams University

100 Clinical Results associated with Insulin glargine (Sanofi)

100 Translational Medicine associated with Insulin glargine (Sanofi)

100 Patents (Medical) associated with Insulin glargine (Sanofi)

2,030

Literatures (Medical) associated with Insulin glargine (Sanofi)

Small (Weinheim an der Bergstrasse, Germany)

Comparative Analysis of PEG‐Free and PEG‐Based Self‐Emulsifying Drug Delivery Systems for Enhanced Oral Bioavailability of Therapeutic (Poly) Peptides

Article

Author: Bernkop-Schnürch, Andreas ; Haddadzadegan, Soheil ; To, Dennis ; Laffleur, Flavia ; Matteo Jörgensen, Arne ; Wibel, Richard

Abstract:

This study aims to compare the potential of Polyethylene glycol (PEG‐free and PEG‐based self‐emulsifying drug delivery systems (SEDDS) for the oral administration of insulin glargine (IG). Hydrophobic ion pairs (HIPs) of IG are formed using various counterions. HIPs are assessed for log P octanol/water and dissociation behavior. They are incorporated into SEDDS based on polyglycerol (PG) and zwitterionic surfactant (ZW) using response surface methodology and compared to conventional PEG‐SEDDS in size, stability, and log D SEDDS/release medium. Oral IG bioavailability in PG/ZW‐SEDDS and PEG‐SEDDS is evaluated in rats. Among the various counterions studied, IG‐BIS (bis(isotridecyl)sulfosuccinate) HIPs demonstrated the highest log P and an improved dissociation profile. PG/ZW‐SEDDS and PEG‐SEDDS have similar ≈40 nm sizes and are stable over 24 h. Both formulations have log D > 4 in water and >2 in 50 mM phosphate buffer pH 6.8. PG/ZW‐SEDDS yielded an oral bioavailability of 2.13 ± 0.66% for IG, while the employment of PEG‐SEDDS resulted in an oral bioavailability of 1.15 ± 0.35%. This study highlights the prospective utilization of PEG‐free SEDDS involving the concurrent application of PG and ZW surfactants, an alternative to conventional PEG surfactants, for improved oral therapeutic (poly) peptide delivery.

01 Feb 2024·Hospital pharmacy

Insulin Glargine Associated Nausea in a Patient Seen by a Collaborative Drug Therapy Management Pharmacist in an Urban Community Hospital: A Case Report

Author: Gerber, Anthony ; Quinn, Rachel

Background: Diabetes mellitus has become increasingly prevalent and a considerable health risk in the United States. Early introduction of insulin can improve overall health outcomes of patients with diabetes. With the development of long-acting insulin analogs, such as insulin glargine, limitations such as variable absorption and hypoglycemia were reduced. Majority of reported adverse drug effects secondary to insulin glargine include injection site reaction and hypoglycemia. There is limited data on gastrointestinal adverse effects, including nausea, of insulin glargine. Case Presentation: A 51-year-old female with a past medical history of type 2 diabetes was referred to the collaborative drug therapy management pharmacist for diabetes education and management. The patient was initiated on insulin glargine (Lantus®) and began to experience episodes of nausea and emesis over a 9 week period. Once the patient was switched from insulin glargine (Lantus®) to insulin detemir, symptoms subsided. Upon re-trial of insulin glargine (Lantus®), nausea and emesis-like symptoms resumed. A probable relationship between insulin glargine (Lantus®) and the reaction was estimated using the Naranjo Adverse Drug Reaction Probability Scale. Conclusion: Potential mechanisms behind the relationship of insulin glargine (Lantus®) and nausea are hypothesized, however there is limited literature supporting this claim and further investigation is warranted.

01 Feb 2024·Diabetes, obesity & metabolism

Treatment responses to basal insulin glargine 300 U/ml and glargine 100 U/ml in newly defined subphenotypes of type 2 diabetes: A post hoc analysis of the EDITION 3 randomized clinical trial

Article

Author: Bolli, Geremia B ; Landgraf, Wolfgang ; Frier, Brian M ; Owens, David R

Abstract:

Introduction:

To compare responses to basal insulin glargine 300 U/ml (IGlar‐300) and 100 U/ml (IGlar‐100) in newly defined subphenotypes of type 2 diabetes.

Methods:

Insulin‐naive participants (n = 858) from the EDITION 3 trial were assigned to subphenotypes ‘Mild Age‐Related Diabetes (MARD)’, ‘Mild Obesity Diabetes (MOD)’, ‘Severe Insulin Resistant Diabetes (SIRD)’ and ‘Severe Insulin Deficient Diabetes (SIDD)’. Key variables were analysed at baseline and 26 weeks.

Results:

Participants were comprised of MOD 56.1% (n = 481), SIDD 22.1% (n = 190), MARD 18.2% (n = 156) and SIRD 3.0% (n = 26). After 26 weeks a similar decrease in glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) of 16‐19 mmol/mol and 1.4‐1.7 mmol/L, respectively, occurred in MARD and MOD with both insulins. SIDD had the most elevated HbA1c and FPG (80‐83 mmol/mol/11.1‐11.4 mmol/L) and reduction in both HbA1c and FPG was greater with IGlar‐100 than with IGlar‐300 (−18 vs. −15 mmol/mol and −1.6 vs. −1.3 mmol/L, respectively; each p = .03). In SIDD, despite receiving the highest basal insulin doses, HbA1c decline (57‐60 mmol/mol/7.3‐7.6%) was suboptimal at week 26. In MOD and SIDD lower incidences with IGlar‐300 were found for level 1 nocturnal hypoglycaemia [odds ratio (OR) 0.59, 95% confidence intervals (CI) 0.36‐0.97; OR 0.49, 95% CI 0.24‐0.99]. In addition, fewer level 2 hypoglycaemia episodes occurred at any time with IGlar‐300 in SIDD (OR 0.31, 95% CI 0.13‐0.77).

Conclusion:

Both insulins produce comparable outcomes in type 2 diabetes subphenotypes, but in SIDD, add‐on treatment to basal insulin is required to achieve glycaemic targets.

News (Medical) associated with Insulin glargine (Sanofi)

01 Jul 2024

·www.echemi.com

French Pharmaceutical Giant Sanofi to Invest €13-15 Billion in German Production Facility

According to a report in the German business newspaper on Monday, the French pharmaceutical giant Sanofi plans to make a major investment of between €13 billion and €15 billion (equivalent to $14 billion to $16 billion) in its large production facility located in Frankfurt, Germany, for the manufacturing of its insulin brand Lantus. The report, citing sources within the German government, indicates that Sanofi initially considered shifting Lantus production to France, but has since changed its strategy. The company is now close to committing to an upgrade and renovation of its factory in the Höchst district of Frankfurt, Germany. Sanofi has not yet responded to requests for comment on this report. It is worth noting that the German governing coalition has recently succeeded in attracting multiple investments in the healthcare sector. For instance, Daiichi Sankyo (4568.T) announced in February that it will invest around €1 billion to drive its precision anti-cancer drug development work near Munich. Additionally, the American pharmaceutical company Eli Lilly announced in November last year that it will invest €2.3 billion in Germany to produce drugs for the treatment of obesity and diabetes. (Exchange rate: 1 USD = 0.9299 EUR)

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

100 Deals associated with Insulin glargine (Sanofi)

External Link

KEGG	Wiki	ATC	Drug Bank
D03250	Insulin glargine (Sanofi)	A10AE04	DB00047

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	EU	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	IS	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	LI	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	NO	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus, Type 1	US	Sanofi-Aventis U.S. LLC	20 Apr 2000
Diabetes Mellitus, Type 2	US	Sanofi-Aventis U.S. LLC	20 Apr 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	US	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	AR	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	BR	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	CA	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	MX	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	US	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	AR	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	BR	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	CA	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	MX	Sanofi	01 Apr 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2023	Not Applicable	Sex hormone-binding globulin (SHBG) \| testosterone	-	Glargine	iwpbydnads(pigenofxmf) = bodhhmbgof tjnhclsmdo (nykltszxxr )	-	26 Aug 2023
				Glargine	iwpbydnads(pigenofxmf) = ilcunlzswj tjnhclsmdo (nykltszxxr )
RESTORE-G (ADA2023)	Not Applicable	-	-	Glargine 300 U/mL	vqjgrifpia(lbmjcdfujo) = iiqcoreuqz qkaiargwgd (jyuudknjxy )	-	23 Jun 2023
ADA2023	Not Applicable	-	-	Bridging dose of G with first dose of D	mudiydvxqe(oweeyeglha) = vizdajaway rwwqztxhbc (yrqppigzhw )	-	20 Jun 2023
				Placebo	eyggsaaneb(vduerfjrkd) = qcvkgxzorb hqxzcbqlgz (ntkxhlsrcd )
NCT04567225 (CTgov)	Phase 4	Diabetic Ketoacidosis \| Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Type 1	39	IV insulin infusion+Early Glargine (Early Glargine)	iwbuakuxrf(nsjplhegzs) = mlxpjmcjes teblrpslhs (iqvnhraani, baxwicxevd - iayvdqohnn) View more	-	25 Aug 2022
				IV insulin infusion+Late Glargine (Standard Practice (Late Glargine))	iwbuakuxrf(nsjplhegzs) = fawhxykglz teblrpslhs (iqvnhraani, tpbkpvaeif - eoobbbageu) View more
ADA2022	Not Applicable	Diabetes Mellitus, Type 2	-	NPH	azegbebliu(bnfbllgdam) = ncszzbwoex dwbiuletpt (nztzdiwjam )	-	01 Jun 2022
EUCTR2019-003209-89-AT (ADA2022)	Not Applicable	Diabetes Mellitus, Type 1	25	Insulin Glargine U300 100%	vljbxxvbwa(wsasmyzdfh) = yasuhvffgp neyupscwab (dxqzopdiln )	-	01 Jun 2022
				Insulin Degludec 100%	vljbxxvbwa(wsasmyzdfh) = szoolyxkzi neyupscwab (dxqzopdiln )
ADA2022	Not Applicable	-	-	Insulin Glargine 100 U/mL (Gla-100)	cxlfulftoz(buurbwhojj) = ntmiqrqhjf bgjjtswrzk (iifvnoauyx )	Positive	01 Jun 2022
				Insulin Glargine 300 U/mL (Gla-300)	cxlfulftoz(buurbwhojj) = bweznlwvij bgjjtswrzk (iifvnoauyx )
ADA2022	Not Applicable	Diabetes Mellitus, Type 2	-	Continued treatment with Gla-300	vlsdwsrczy(wsbaqujdtp) = ponmxanqru ouwmxomavm (jvjahiaewp ) View more	-	01 Jun 2022
				Switched to 1st-gen BI analog (Gla-100 or IDet)	vlsdwsrczy(wsbaqujdtp) = hhkljpbmop ouwmxomavm (jvjahiaewp ) View more
NCT03107208 (CTgov)	Phase 4	Diabetic Ketoacidosis \| Diabetes Mellitus, Type 1 \| Rebound hyperacidity	61	glargine (Early Glargine (Lantus))	awhagfttua(nqploidskm) = sbhcdtpite hntwuylhvc (uqqobiwjsx, klvsflkhyd - cnlncgwcfx) View more	-	10 May 2022
				glargine (Control Group)	awhagfttua(nqploidskm) = apbxbyitno hntwuylhvc (uqqobiwjsx, rzzejnqqbk - wsggrqyuoi) View more
NCT04157738 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	24	Rapid-Acting Insulin+Long acting insulin (Fixed Group)	bctmjggkim(ujyciczyht) = icqazvwjth hfmtyfgilp (zzyxcbtkgr, zwbvlsjfwf - rctqydmreb) View more	-	30 Sep 2021
				Rapid-Acting Insulin+Long acting insulin (Insulin to Carbohydrate Ratio (ICR) Group)	bctmjggkim(ujyciczyht) = sblckpuhuh hfmtyfgilp (zzyxcbtkgr, nusczywmtd - rtplugpcln) View more

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