The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).

Start Date01 Jan 2020

Sponsor / Collaborator

Warszawski Uniwersytet Medyczny

NCT04124302 / Unknown statusPhase 4IIT

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.

The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.

Start Date01 Nov 2019

Sponsor / Collaborator

Warszawski Uniwersytet Medyczny

NCT03529123 / CompletedPhase 3

A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal Insulin With or Without Metformin

Primary Objective:
To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).
Secondary Objectives:
To assess the effects of the FRC in comparison with insulin glargine on:
Percentage of patients reaching HbA1c targets (<7% );
Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
Body weight
Fasting Plasma Glucose (FPG);
Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
7-point Self-Monitoring Plasma Glucose (SMPG) profile;
Insulin glargine dose.
To assess the safety and tolerability in each treatment group.

Start Date19 Jun 2018

Sponsor / Collaborator

Sanofi SA

100 Clinical Results associated with Insulin Glulisine Recombinant

100 Translational Medicine associated with Insulin Glulisine Recombinant

100 Patents (Medical) associated with Insulin Glulisine Recombinant

336

Literatures (Medical) associated with Insulin Glulisine Recombinant

01 Dec 2024·Phytomedicine

Jia Wei Qingxin Lotus Seed Drink ameliorates epithelial mesenchymal transition injury in diabetic kidney disease via inhibition of JMJD1C/SP1/ZEB1 signaling pathway

Article

Author: Zuo, Anna ; Yang, Peiyuan ; Luo, Yanyu ; Lin, Haoyu ; Wang, Ming ; Lin, Wenming ; Yuan, Daijiao ; Jin, Fuhua ; Xie, Jiarun ; Song, Jianda ; Yao, Wang ; Sun, Jia

BACKGROUNDDiabetic kidney disease (DKD) is one of the most common microvascular complications in patients with diabetes mellitus. In this condition, renal tubular epithelial mesenchymal transition (EMT) is an important factor accelerating the progression of DKD and a major cause of renal fibrosis and end-stage renal disease. However, the therapeutic effect is unsatisfactory because of the lack of effective drugs. Jia Wei Qingxin Lotus Seed Drink (QISD) is a traditional Chinese medicine compound formula that has shown to be effective in the clinical treatment of DKD. However, the potential of QISD in DKD-EMT treatment has yet to be fully explored.PURPOSEThis study aimed to investigate the role of QISD in ameliorating DKD-EMT injury and its mechanism.METHODSThe active ingredients of QISD were identified via ultra-performance liquid chromatography-mass spectrometry/mass spectrometry (UHPLC-MS/MS). A DKD mouse model was constructed by high-fat diet feeding and intraperitoneal injection of STZ (60 mg/kg), and QISD (14.46, 28.92, and 57.84 g/kg/day) was administered by gavage for 12 consecutive weeks. Dapagliflozin (1 mg/kg/d) was used as a positive control. Renal pathological damage was observed by HE, PAS, and Masson staining. The expression levels of EMT-related proteins and pathway proteins were detected via immunohistochemistry, RT-qPCR, and western blot. In in vitro experiments, EMT injury was induced in human kidney tubular epithelial cells (HK-2) by using lipopolysaccharide (LPS). A combination of CCK8 assay, wound healing assay, small-molecule inhibitor intervention, and overexpression lentiviral transfection was used to investigate the effects of QISD on cell migration ability, adhesion ability, fibrotic factor formation, and mesenchymal properties.RESULTSAnimal experiments showed that QISD improved blood glucose, body weight, symptoms of excessive drinking and eating, and renal pathological injury in mice, reduced extracellular matrix deposition, delayed renal EMT injury, and inhibited the activation of the histone demethylase JMJD1C. UHPLC-MS/MS and molecular docking indicated that baicalin, wogonoside, oroxylin A-7-O-β-D-glucuronide, and glulisine A found in QISD could bind to JMJD1C. The ameliorating effect of QISD on DKD-EMT injury might be related to JMJD1C. The improvement of DKD-EMT injury by QISD was accompanied by the reduction of SP1 and ZEB1 expression. The SP1 overexpression not only reversed the therapeutic effect of JIB-04, an inhibitor of JMJD1C, on DKD-EMT but also exacerbated the expression of ZEB1 and downstream EMT-related factors. Thus, QISD might affect the expression of the epithelial marker E-cadherin by inhibiting the JMJD1C/SP1/ZEB1 signaling pathway, consequently preventing the transformation of epithelial cells to mesenchymal cells and ameliorating DKD-EMT injury.CONCLUSIONThis study was the first to demonstrate that QISD might ameliorate DKD-EMT injury by inhibiting the JMJD1C/SP1/ZEB1 signaling pathway. These findings provide strong pharmacologic evidence for the clinical use of QISD in the treatment of DKD.

01 Aug 2024·Die Pharmazie

Optimization of a mass spectrometric analytical method for the quality assessment of insulin and its analogs.

Article

Author: Pajaziti, B A ; Kemlendi, N ; Pajaziti, B ; Andrási, M ; Nebija, D

The principal aim of this study was to optimize analytical methodology based on mass spectrometry for the evaluation of the quality of recombinant human insulin and its analogs. In this study ESI-MS was used to assess the quality of human insulin, short acting insulin analogs, insulin lispro, insulin aspart and insulin glulisine and long acting analogs including insulin glargine, insulin degludec, and insulin detemir, in respective pharmaceutical formulations. In this study, with the aimed to optimize analytical conditions, different factors influencing the analytical performance such as pH, ionic strength, sample dilution, organic solvent addition were addressed. The study results demonstrated that MS is a suitable technique for the analysis of biotechnological compounds like insulin and its analogs. Although the obtained results provide an important information regarding this methodology, further studies are needed to validate this analytical approach and check for its suitability to be used in the regulatory environment.

01 Jul 2024·Clinical Pharmacology in Drug Development

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

Article

Author: Arefeva, Anna ; Dorotenko, Artem ; Drai, Roman ; Noskov, Sergei ; Koksharova, Ekaterina ; Galstyan, Gagik ; Protsenko, Ekaterina ; Makarenko, Igor ; Radaeva, Kseniia ; Gefen, Maria

AbstractThe aim of the study was to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of T‐glu (GP40321, test drug), and reference insulin glulisine in a hyperinsulinemic‐euglycemic clamp procedure. During this study, 34 healthy male volunteers underwent the hyperinsulinemic‐euglycemic clamp procedure following subcutaneous 0.3 U/kg injection of T‐glu or reference insulin glulisine in a randomized, double‐blind, crossover study. Plasma glucose levels were monitored every 5 minutes for 8 hours. Glucose infusion rate adjustment was based on the blood glucose measurements. Evaluation of PD was performed using the glucose infusion rate values, while PK was calculated using insulin concentrations measured via enzyme‐linked immunosorbent assay. The study results showed that the 90% CI for the geometric mean ratios of primary PK and PD of T‐glu and reference insulin glulisine were within 80%‐125% comparability limits, and that the safety profiles were comparable. PK, PD, and safety similarity of T‐glu and reference insulin glulisine was demonstrated.

News (Medical) associated with Insulin Glulisine Recombinant

18 Apr 2023

·www.pharmaceutical-technology.com

Insulin pricing in flux as major pharma players take action

Credit: Getty images/ Artur Debat As the three main US pharmaceutical insulin suppliers, Novo Nordisk , Sanofi and Eli Lilly , have announced major price reductions , and the US government is pushing caps on out-of-pocket costs for their blockbuster insulins, experts say the tides may soon be turning for insulin afccess in the US. Free Buyers Guide Leading Guide to Pharma Benefit Managers and Management Companies for the Pharmaceutical Industry The document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with Pharma Buyers Guide and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Buyers Guide. On March 1, Eli Lilly announced a 70% price reduction for its most commonly prescribed insulins a few months after losing $15 billion in market cap after a fake tweet. Novo Nordisk soon followed suit with plans to cut the cost of its pre-filled pens and vials. In the midst of growing public sentiment against price hikes, Sanofi also followed suit by cutting prices for its most popular insulin product Lantus (insulin glargine) by 78%. This is not the first time that insulin pricing has been in the spotlight. In April 2022, the US House of Representatives passed the Affordable Insulin Act , as part of the Inflat ion Reduction Act (IRA), which set a pric e cap for insulin copays of $35 per month. However, this affected insulin prices only for patients above the age of 65 years on Medicare, and several diabetes organisations called for wider action. Still, in August 2022, 43 senators voted against including patients on commercial insurance plans in the group with capped prices. More recently, on March 23, Senators John Kennedy and Raphael Warnock put forward a bipartisan bill to cap insulin costs for all citizens. Dr. Irl B. Hirsch, the former chair of the Professional Practice Committee for the American Diabetes Association , says, “[Insulin pricing] has become not just a medical issue, but a political issue based on a very complex pricing situation with insulin in the United States.” At the same time, pressure on the big three insulin companies continued to rise, as multiple states like California filed lawsuits alleging that companies and some pharmaceutical benefit managers (PBMs) had leveraged their control of the market to overcharge patients. Experts attribute the extremely high insulin prices to a dysfunctional rebate system involving PBMs, consistent price gouging, and a flawed healthcare system. Sachiko Ozawa, PhD, a health economist at the University of North Carolina at Chapel Hill, says the extravagant insulin prices seen in recent years have even caused some diabetics to partake in high-risk behaviors such as online purchases from illegitimate websites. “These rogue or illegitimate online pharmacies are really catering to a population that’s looking for cheaper insulin prices,” says Ozawa. Still, Aaron Turner-Phifer, the director of Health Policy at the nonprofit Juvenile Diabetes Research Foundation (JDRF), says the recent price cuts from the major insulin companies and last year’s IRA-related developments have been encouraging. He says, “Each of these actions mean that people who couldn’t otherwise afford their insulin to live, now can do so. [But] this is not the end of the issue and there are a number of things that need to happen to ensure that everyone regardless of their insurance status has access to affordable insulin.” The history of insulin pricing As per the Centers for Disease Control and Prevention, 37.3 million people or 11.3% of the US population have diabetes. In 2017, the American Diabetes Association found that $237 billion was spent in direct medical costs related to diabetes . A high burden of insulin costs factors into this, with the current average price of $636 for 5 units (100IU/ml) for pre-filled insulin pens. This average takes into account the eleven branded preselected insulins in the figure, according to GlobalData’s Price Intelligence database. Turner-Phifer says there are two issues that moved in parallel to lead the US to the current insulin affordability crisis—high list prices and high out-of-pocket costs. For uninsured US citizens, Turner-Phifer says that the rebate system is the main culprit for high out-of-pocket costs. Critics allege insulin manufacturers increase list prices and give large rebates to PBMs to then prioritise those insulins on their formularies. PBMs in turn argue they negotiate with manufacturers to obtain lower prices and blame the lack of market competition among manufacturers as the culprit. Frank Wharam, a health policy researcher at the Duke Margolis Center for Health Policy, found that even commercially insured US citizens, particularly those with high-deductible health plans, had increased out-of-pocket costs when it came to insulin. In 2020, Colorado began a trend of states putting their own caps on out-of-pocket costs for insulin. Wharam explains that this was a good short-term solution but did not fix the issue as manufacturers continued to increase their prices. “You’re [the consumer] getting a reduced cost, but someone is paying for it,” he says. Wharam also explains why after 2017, insulin prices began to settle with less-sharp price increases: “In the next few years [2017–20], the situation got a lot of publicity…and politicians became highly aware of it and put it pretty high on their legislative agenda. Private actors in the US system will pay attention to enough political pressure.” Furthermore, Wharam explains that this period is when more players entered the US insulin landscape, developing biosimilars and generics, and states like Colorado began to put caps on prescription insulin. He says, “However it happened, it's a positive development for patients.” In this analysis, the highest list price of selected insulin pens was taken from January of each year, and then averaged for each company. Each company launched new insulins to the market at different points within this timeline. A changing insulin market The recent price changes may indicate the beginning of flux in the insulin market. Eli Lilly said each 100 units/mL vial of Insulin Lispro, a popular short-acting manmade insulin, will cost $25 per vial starting May 1. Humalog and Humulin’s prices will also be reduced by 70% from Q4 2023 onwards. Lilly is also launching Rezvoglar (insulin glargine-aglr), a basal insulin biosimilar that is interchangeable with Lantus, for $92 per five-pack of KwikPens. In addition, Novo Nordisk is also lowering list prices of its basal long-acting, bolus short-acting, and pre-mix insulins. Specifically, these include Levemir (insulin detemir), Novolin (insulin regular), NovoLog (insulin aspart), and NovoLog Mix 70/30. Hirsch speculates that negative public sentiment, which has been “severe” for some time, and a changing diabetes therapeutic market may have triggered the recent announcements. Furthermore, the growing popularity of therapies that target GLP1 like Ozempic (semaglutide), Trulicity (dulaglutide), and Mounjaro (tirzepatide) is causing a shift in the landscape, says Hirsch. The tremendous weight loss that patients see with these drugs makes insulin requirements lower for type 2 diabetes patients, Hirsch explains. “They’ve made their billions of dollars on the insulin, so they can look in the rear-view mirror with insulin as they don’t need it anymore, especially Novo Nordisk and Lilly.” Lilly markets Mounjaro (tirzepatide) and Trulicity (dulaglutide) indicated for type 2 diabetes, and Novo Nordisk markets Ozempic. These drugs are approved as treatment for diabetes but are also being prescribed off-label for obesity, and are popular enough to result in drug shortages. Combination insulins with GLP-1 agonists are already more expensive than standard insulins. For example, Novo Nordisk’s Xultophy (insulin degludec and liraglutide) is $12,057 for a pre-filled pen (with a strength of 100IU/ml) per 5 units. Additionally, other entities are also shaking up the space. Civica Rx, a non-profit generic drug company, announced a partnership with the state of California to produce cheaper biosimilar insulins for the CalRx Biosimilar Insulin initiative. Hirsch suspects that Civica Rx’s project may be particularly successful due to its method of bypassing PBMs to get insulin to patients. However, Turner-Phifer is cautious about the recent news from the insulin companies, saying, “Several of these announcements are simply announcements for things to come in the future. And there's no security that two or five years from now, other dynamics might be at play, and prices may be going back up.” He continues, “The system for insulin in the US is broken.” “The good news is that insulin [pricing] has received so much publicity about the inequities of insulin access that most Americans, independent of their political persuasion, agree that we need to give underserved people and people of color access to insulin…but it’s going to take years to get there,” says Turner-Phifer. With data analysis support from GlobalData principal research analyst Alex Watt. Free Buyers Guide Leading Guide to Pharma Benefit Managers and Management Companies for the Pharmaceutical Industry The document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision. By Pharma Buyers Guide Submit Country Code UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with Pharma Buyers Guide and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Buyers Guide. Branded Name Generic Name Company Current Prices ($ USD) per 5 units Average Annual Treatment Cost ($ USD) BASAGLAR INSULIN GLARGINE Eli Lilly 391.63 HUMALOG INSULIN LISPRO Eli Lilly 636.48 5162.56 LYUMJEV INSULIN LISPRO Eli Lilly 636.48 5162.56 FIASP INSULIN ASPART Novo Nordisk 670.6 3120.79 NOVOLIN N INSULIN (HUMAN) Novo Nordisk 312.3 TRESIBA INSULIN DEGLUDEC Novo Nordisk 610.12 4948.72 XULTOPHY INSULIN DEGLUDEC; LIRAGLUTIDE Novo Nordisk 1486.46 12056.87 ADMELOG INSULIN LISPRO Sanofi 227.22 LANTUS INSULIN GLARGINE Sanofi 525.68 4263.88 SOLIQUA INSULIN GLARGINE; LIXISENATIDE Sanofi 1018.14 8258.25 SEMGLEE INSULIN GLARGINE Viatris 484.85 INSULIN LISPRO INSULIN LISPRO Eli Lilly 190.94 INSULIN ASPART INSULIN ASPART Novo Nordisk 335.29 INSULIN GLARGINE INSULIN GLARGINE Viatris 177.58 INSULIN GLARGINE INSULIN GLARGINE Winthrop/ Sanofi 204.142012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Eli Lilly (Branded) 284.16 325.32 388.74 469.8 549.18 485.31 514.055 514.055 514.055 554.8633333 554.8633333 554.8633333 Novo Nordisk (Branded) 252.17 272.34 363.74 447.31 508.41 720.2133333 699.825 656.566 617.9716667 628.3683333 639.0683333 664.2 Sanofi (Branded) 246.48 273.92 363.74 447.31 447.31 604.655 587.9133333 610.7866667 553.8166667 565.41 555.1633333 569.0833333Combination therapies of insulin and GLP-1 agonists have a higher average annual treatment cost Average annual cost of US branded pre-filled pen insulins (with a strength of 100 IU/ml) per 5 units in March 2023. Branded Name Generic Name Company Average Annual Treatment Cost ($ USD) HUMALOG INSULIN LISPRO Eli Lilly 5162.56 LYUMJEV INSULIN LISPRO Eli Lilly 5162.56 FIASP INSULIN ASPART Novo Nordisk 3120.79 TRESIBA INSULIN DEGLUDEC Novo Nordisk 4948.72 XULTOPHY INSULIN DEGLUDEC; LIRAGLUTIDE Novo Nordisk 12056.87 APIDRA INSULIN GLULISINE Sanofi 5338.93 LANTUS INSULIN GLARGINE Sanofi 4263.88 SOLIQUA INSULIN GLARGINE; LIXISENATIDE Sanofi 8258.25 TOUJEO INSULIN GLARGINE Sanofi 1471.4 Source: GlobalData

Drug Approval

17 Mar 2023

·www.pharmamanufacturing.com

Sanofi caps insulin at $35 per month

Sanofi this week that it will be slashing the list price of its most widely prescribed insulin, Lantus, by 78%, and its short-acting Apidra by 70%. According to Sanofi, with the price discounts, no insured patient will pay more than $35 out of pocket for insulin.The new prices will go into effectJanuary 1, 2024. Sanofi launched its unbranded biologic for Lantus at 60% less than the branded list price. But, according to Olivier Bogillot, Sanofi's head of U.S. General Medicines, inherent structural challenges prevented the U.S. health system from taking advantage of the discount. Now Sanofi is joining other drugmakers like who are providing hefty discounts to both their biosimilars and branded insulins.

16 Mar 2023

·www.globenewswire.com

Press Release: Sanofi cuts U.S. list price of Lantus®, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance

Sanofi cuts U.S. list price of Lantus®, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance Paris, March 16, 2023. Sanofi announces that it will cut the list price of Lantus (insulin glargine injection) 100 Units/mL, its most widely prescribed insulin in the U.S., by 78 percent. The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance, underscoring its longstanding commitment to offer affordable access to medicines. These moves, which go into effect January 1, 2024, will come in addition to decisions taken in June 2022 to lower diabetes medicines costs: the launch of an unbranded Lantus biologic at -60% versus Lantus list price, and a cap on out-of-pocket costs on insulin to $35 for all people without insurance. With all those decisions, now Sanofi’s suite of savings programs ensures that no patient will pay more than $35 for a monthly supply of Lantus. Finally, Sanofi will also cut the list price of its short-acting Apidra (insulin glulisine injection) 100 Units/mL by 70%. Olivier BogillotHead, U.S. General Medicines, Sanofi“Sanofi believes that no one should struggle to pay for their insulin and we are proud of our continued actions to improve access and affordability for millions of patients for many years. We launched our unbranded biologic for Lantus at 60 percent less than the Lantus list price in June 2022 but, despite this pioneering low-price approach, the health system was unable to take advantage of it due to its inherent structural challenges. We are pleased to see others join our efforts to help patients as we now accelerate the transformation of the U.S. insulin market. Our decision to cut the list price of our lead insulin needs to be coupled with broader change to the overall system to actually drive savings for patients at the pharmacy counter.” Sanofi Savings Programs Sanofi will continue to provide different programs to ensure access and affordability to patients depending on their coverage situations and will continue to monitor policy and market changes. Our suite of innovative programs includes: 100% of commercially insured people are eligible for Sanofi’s copay assistance programs, regardless of income or insurance plan design, which, in 2022 limited out-of-pocket expenses for a majority of participating patients to $15 or less for their diabetes medicines for a 30-day supply.100% of uninsured people are eligible for the Insulins Valyou Savings Program – regardless of income level – enabling them to buy one or multiple Sanofi insulins at $35 for a 30-day supply. The Soliqua (insulin glargine and lixisenatide) injection 100 Units/mL and 33 mcg/mL cash offer also allows uninsured people to pay as little as $99 per box of pens, for up to two boxes of pens for a 30-day supply. We also provide free medications to qualified low- and middle-income patients the Sanofi Patient Connection program. Some people facing an unexpected financial hardship may be eligible for a one-time, immediate month’s supply of their Sanofi medicine as they wait for their application to process. Beginning in 2023, Sanofi insulins and Soliqua are included under the Inflation Reduction Act, where covered on Medicare formulary, which provides insulin savings, capping monthly cost at $35 for Seniors who have Medicare Part D. This ensures a predictable, stable co-pay, regardless of phase including the donut hole. Prior to the Inflation Reduction Act, Sanofi voluntarily participated in part of the Centers for Medicare and Medicaid Services’ (CMS) Senior Savings Model which allowed patients enrolled in participating Part D plans to pay a $35 or less co-pay for each 30-day prescription of a Sanofi insulin throughout the year. Every patient has unique circumstances, and Sanofi has live support specialists who can be reached at (855) 984-6302 to answer individual patient’s questions and navigate their unique situation to find the best resources and programs to help lower their out-of-pocket costs. Learn more about Sanofi’s transparent approach to pricing in our 2023 Pricing Principles Report. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release

100 Deals associated with Insulin Glulisine Recombinant

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KEGG	Wiki	ATC	Drug Bank
-	Insulin Glulisine Recombinant	A10AB06	DB01309

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	JP	Sanofi	19 Jun 2009
Diabetes Mellitus, Type 1	JP	Sanofi	08 Apr 2009
Diabetes Mellitus	US	Sanofi-Aventis U.S. LLC	16 Apr 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infarction	Phase 2	BR	Sanofi	01 Apr 2008
Infarction	Phase 2	AR	Sanofi	01 Apr 2008
Infarction	Phase 2	CA	Sanofi	01 Apr 2008
Infarction	Phase 2	MX	Sanofi	01 Apr 2008
Infarction	Phase 2	US	Sanofi	01 Apr 2008
Diabetes Mellitus, Insulin-Dependent, 2	Discovery	US	Sanofi	01 Aug 2005
Diabetes Mellitus, Type 2	Discovery	US	Sanofi	01 Apr 2004
Diabetes Mellitus, Type 1	Discovery	FR	Sanofi SA	01 May 2002
Diabetes Mellitus, Type 1	Discovery	NL	Sanofi SA	01 May 2002
Diabetes Mellitus, Type 1	Discovery	DE	Sanofi SA	01 May 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00913497 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	16	insulin glulisine (Insulin Glulisine)	rwzuiluunr(fvgdgzssxk) = tmmwuktbra ftfgqlomrm (urneuiokfn, kllxolquhl - hmdkzwywbj) View more	-	18 Sep 2023
				Insulin Aspart (Insulin Aspart)	rwzuiluunr(fvgdgzssxk) = hfwqbqetrv ftfgqlomrm (urneuiokfn, veejlwxljv - nneolrvugn) View more
NCT02503501 (CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	49	Insulin glulisine (Insulin Glulisine)	gwcoiwsrsj(qytomwjeps) = mrbbtlmzjc jjltxszmhc (ioqsklbhbd, rttxjntuei - xyiuqdncuo) View more	-	09 Apr 2020
				Placebo (Placebo)	gwcoiwsrsj(qytomwjeps) = xxwwcmjlic jjltxszmhc (ioqsklbhbd, qimbcacciq - mnocatjexs) View more
NCT02432716 (CTgov)	Phase 1	Down Syndrome	12	Insulin glulisine+saline (Insulin (Glulisine), Then Placebo)	fcplrzgorl(chysdyahss) = tewbkrfqew wpdmavjdvs (nxydbgrrhu, pwspkyscks - lwurxewsqw)	-	06 Dec 2019
				Insulin glulisine+saline (Placebo, Then Insulin (Glulisine))	fcplrzgorl(chysdyahss) = cvpaxpeycu wpdmavjdvs (nxydbgrrhu, reademjbjc - pbwtjxbxhy)
NCT00911625 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Renal Insufficiency	114	Apidra+Lantus (0.5 Units/kg)	mvuntltusi(ocaalitvtx) = fpwkhbsikt tzqbdhlgrq (jladyoxdpf, mvwvlyylqf - htbxqtijzy) View more	-	10 Mar 2017
				Apidra+Lantus (0.25 Units/kg)	mvuntltusi(ocaalitvtx) = vwevfkiagu tzqbdhlgrq (jladyoxdpf, neviwsxjjy - hmnfljeymi) View more
NCT01212913 (Pubmed \| J Diabetes) Manual	Phase 4	Diabetes Mellitus, Type 2	-	insulin glulisine	(gyjcaypqzt) = ezfsclpogf mreixgzxov (tvkvqudcew, 0.09)	Positive	01 May 2016
				insulin aspart/insulin aspart protamine	(gyjcaypqzt) = lyxuohggsx mreixgzxov (tvkvqudcew, 0.09)
NCT01131052 (DMElderly, CTgov)	Phase 4	Diabetes Mellitus \| Hyperglycemia	150	Insulin Glargine+Insulin glulisine (Basal Plus)	cuussyzynb(iinusbsyli) = rnvocrwghs rshcvknevp (aeqexxiwji, drvunympsp - enprlfqooy) View more	-	31 Dec 2014
				Insulin (Sliding Scale Regular Insulin (SSRI))	cuussyzynb(iinusbsyli) = yswwceaznb rshcvknevp (aeqexxiwji, xbgykzcoei - koatsyqzrn) View more
NCT01848990 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	456	Insulin aspart+Insulin glulisine+Insulin Lispro (Standard Rapid-Acting Insulin CSII)	awhafrdjyz(kfyinztdjc) = yijioytwca ineytxppim (ewkdxihagg, xpghntxink - yvhkqlqlgm) View more	-	29 Oct 2014
				Insulin aspart+Insulin glulisine+Insulin Lispro (Standard Rapid-acting Insulin CSII)	ghlteuqpex(hlhboidqlo) = sslvluvomu jgprkjjgwl (kdsrkmxjmh, lhqlzdipac - ibtazqqoio) View more
NCT00979628 (Basal-Plus, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Hyperglycemia	375	Apidra+Lantus (Basal Plus Regimen)	kfrazcdybk(hcmsuzvfqj) = halocfwdmb xjumioxlvv (inijsncnkn, oolystgadp - bpfhrktsgv) View more	-	24 Apr 2014
				Basal Bolus (Basal Bolus)	kfrazcdybk(hcmsuzvfqj) = dqgezjrxmw xjumioxlvv (inijsncnkn, akoxipxcif - oxmeoxcowt) View more
NCT01621776 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1 \| Hyperglycemia	107	humalog (Humalog)	mhhtdlugjp(ysjjzjbbaw) = xztdchaass zttoofwlum (olzeodhxxk, jaycqyhbvq - qqoselusln) View more	-	13 Sep 2013
				Apidra (Apidra)	mhhtdlugjp(ysjjzjbbaw) = gsqjwlwkzy zttoofwlum (olzeodhxxk, hopxvmatrz - lflffhvkht) View more
NCT00272064 (ELEONOR, Pubmed \| Diabetes Technol Ther)	Phase 3	Diabetes Mellitus, Type 2	241	insulin glulisine (Telecare)	(nnzjeskxap) = vxcrgzobes oxxagtjlgp (llhyfdzrkk ) View more	Positive	01 Feb 2012
				insulin glulisine (Conventional self-monitored blood glucose (SMBG))	(nnzjeskxap) = jbzulmykul oxxagtjlgp (llhyfdzrkk ) View more

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