Diabetic ketoacidosis (DKA) is a medical emergency that is associated with significant morbidity and mortality for both patients with type I and type II diabetes. By correcting hyperglycemia and inhibiting the release of free fatty acids, insulin administration leads to decreased ketone formation and resolution of acidosis. Short-acting intravenous insulin is often preferred to subcutaneous administration for initial management due to its short half-life and ease of titration, but patients will eventually need to transition to subcutaneous insulin prior to discharge. The timing of initiation or resumption of home long-acting subcutaneous insulin is controversial in the treatment of DKA. It is currently unknown if resuming a portion or all of the patient's home basal regimen during the initial treatment phase of DKA will provide an impact on patient care. The purpose of this study is to evaluate the impact of early glargine administration if the patient was not previously on basal insulin or resuming the patient's home basal insulin regimen within two hours after the start of the intravenous insulin infusion in addition to usual care will improve patient outcomes.

开始日期2022-05-31

申办/合作机构

Health Partners Institute For Education & Research

NCT04974528 / Active, not recruiting临床3期

INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus

INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog [RAA] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza.
Pediatric subjects ≥4 and <18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group.
The study is composed of:
Up to 5-week screening/run-in period
26 week randomized treatment period
26-week treatment extension
4-week follow-up period

开始日期2021-09-29

申办/合作机构

MannKind Corp.

[+1]

NCT04864977 / Withdrawn临床4期

Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study

The main purpose of this study is to evaluate a novel approach for insulin glargine (LY2963016) titration for insulin-naïve adults with type 2 diabetes (T2D)
The study will last about 6 months.

开始日期2021-08-16

申办/合作机构

Eli Lilly & Co.

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项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的文献（医药）

2023-08-28·Endocrine journal

Endocrinological evaluation of dawn phenomenon in patients with diabetes and comparison of insulin glargine U-100 biosimilar (Insulin Glargine BS Injection "Lilly") and glargine U-300 (Lantus XR): a randomized controlled study.

Article

作者: Tamura, Haruka ; Hasebe, Masanori ; Terauchi, Yasuo ; Satoh, Shinobu ; Ito, Kohei

We investigated the pathophysiology of the dawn phenomenon by examining the effects of changes in blood glucose levels from late night to early morning on various hormones in a group taking glargine BS and a group taking Lantus XR, with the goal of achieving better glycemic control. Patients with types 1 and 2 diabetes scheduled for inpatient education were divided into BS and XR groups. Blood glucose levels were tracked from 0:00 to 7:00, while blood samples were extracted at 3:00 and 7:00 to measure glucose levels and hormones related to the dawn phenomenon. Overall, we analyzed blood sample and intermittently scanned Continuous Glucose Monitoring data of 43 and 40 patients, respectively. From 0:00 to 7:00, the mean blood glucose was significantly lower in the BS group, although the fluctuation was similar (p < 0.0001). The BS group also exhibited significantly higher ∆ACTH (p = 0.0215) and ∆ cortisol (p = 0.0430) than the XR group. In the BS group, ∆Glu exhibited a significant negative correlation with ∆ACTH and ∆cortisol (p = 0.0491). Similar findings were not observed in the XR group. These results suggest that XR may be a better choice for long-acting insulin since it is less likely to induce cortisol secretion. Further, analysis of the dawn phenomenon and non-dawn phenomenon groups showed the mean CPR levels at 3:00 and 7:00 were significantly higher in the latter (p = 0.0135). This supports the conventional belief that appropriate basal insulin replacement therapy is a beneficial treatment for the dawn phenomenon.

2023-07-01·Journal of managed care & specialty pharmacy

Utilization, user characteristics, and adverse outcomes of insulin glargine originators and follow-on drug in patients with diabetes in the United States.

Article

作者: Mendelsohn, Aaron B ; Nam, Young Hee ; Toh, Sengwee ; Lockhart, Catherine M ; Marshall, James ; McDermott, Cara L ; Rai, Ashish

BACKGROUND: The first follow-on drug (Basaglar) of the originator insulin glargine (Lantus), a long-acting insulin for treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM), was approved in 2015 in the United States. Information on the uptake, user characteristics, and outcomes of follow-on insulin remains sparse. OBJECTIVE: To describe the utilization, user characteristics, and health outcomes of the follow-on insulin glargine and insulin glargine originators in a large, distributed network of primarily commercially insured patients in the United States. METHODS: We used health care claims data in the US Food and Drug Administration's Sentinel common data model format across 5 research partners in the Biologics & Biosimilars Collective Intelligence Consortium distributed research network. Sentinel analytic tools were used to identify adult users of insulin glargine between January 1, 2011, and February 28, 2021, and describe patient demographics, baseline clinical characteristics, and adverse health events among users of the originators and the follow-on drug, stratified by diabetes type. RESULTS: We identified 508,438 users of originator drugs and 63,199 users of the follow-on drug. The proportions of the follow-on drug users among total insulin glargine users were 9.1% (n = 7,070) for T1DM and 11.4% (n=56,129) for T2DM. Follow-on use rose from 8.2% in 2017 to 24.8% in 2020, accompanied by a steady decrease in the use of originator drugs. Demographics of the users of the originators and follow-on drug were similar among the T1DM and T2DM groups. Overall, follow-on users had poorer baseline health profile and higher proportions of episodes with adverse events in the follow-up. CONCLUSIONS: We found evidence of increased uptake of the follow-on drug relative to the originator products in the post-2016 period. The differences in the base-line clinical characteristics between users of the originator products and the follow-on drug and their relationship with health outcomes merit further research. DISCLOSURES: Sengwee Toh consults for Pfizer, Inc., and TriNetX, LLC. This study was funded by the BBCIC.

2023-06-02·JAMA health forum

Estimated Changes in Insulin Prices and Discounts After Entry of New Insulin Products, 2012-2019.

Article

作者: Hernandez, Inmaculada ; Dickson, Sean ; Gellad, Walid F ; Gabriel, Nico

Importance:

Despite the political salience of insulin prices, no study to date has quantified trends in insulin prices that account for manufacturer discounts (net prices).

Objective:

To describe trends in insulin list prices and net prices faced by payers from 2012 to 2019 and estimate changes in net prices after the 2015 to 2017 entry of new insulin products.

Design, Setting, and Participants:

This longitudinal study included an analysis of Medicare, Medicaid, and SSR Health drug pricing data from January 1, 2012, to December 31, 2019. Data analyses were performed from June 1, 2022, to October 31, 2022.

Exposures:

US sales of insulin products.

Main Outcomes and Measures:

Net prices faced by payers were estimated for insulin products as list prices minus manufacturer discounts negotiated in commercial and Medicare Part D markets (ie, commercial discounts). Trends in net prices were evaluated before and after the entry of new insulin products.

Results:

Net prices of long-acting insulin products increased at an annual rate of 23.6% from 2012 to 2014 but decreased at an annual rate of 8.3% after the introduction of insulin glargine (Toujeo and Basaglar) and degludec (Tresiba) in 2015. Net prices of short-acting insulin increased at an annual rate of 5.6% from 2012 to 2017 but then decreased from 2018 to 2019 after the introduction of insulin aspart (Fiasp) and lispro (Admelog). For human insulin products, which did not experience entry of new products, net prices increased at an annual rate of 9.2% from 2012 to 2019. From 2012 to 2019, commercial discounts increased from 22.7% to 64.8% for long-acting insulin products, from 37.9% to 66.1% for short-acting insulin products, and from 54.9% to 63.1% for human insulin products.

Conclusions and Relevance:

In this longitudinal study of US insulin products, results suggest that insulin prices substantially increased from 2012 to 2015, even after accounting for discounts. The introduction of new insulin products was followed by substantial discounting practices that lowered net prices faced by payers.

项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的新闻（医药）

2024-06-18

·Novo Nordisk

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

上市批准临床结果临床研究

2024-05-16

·FierceBiotech

Lilly keeps on Novo's tail by reporting weekly insulin hits primary endpoint in 2 pivotal trials

New data readouts from Eli Lilly tick off two of the five upcoming efsitora R&D milestones. Eli Lilly finds itself in a familiar position: snapping at the heels of Novo Nordisk. The Indianapolis-based drugmaker kept itself in the slipstream of its regular foe Thursday with positive top-line data from a pair of phase 3 studies of its once-weekly insulin candidate. Lilly and Novo have identified once-weekly basal insulin as a way to slash the burdens on some people with diabetes. Rather than inject 365 daily doses each year, patients could administer 52 weekly shots. Novo is close to making that vision a reality for patients in the U.S., where a FDA advisory committee is set to discuss its filing for approval of Awiqli next week. Lilly is following close behind. Having revealed the top-line success of the QWINT-4 trial late last month, Lilly reported a primary endpoint hit on a second study, QWINT-2, and shared data from both trials Thursday. The studies are part of a five-trial program that is testing Lilly’s basal insulin fusion protein and is nearing completion. QWINT-2 compared Lilly’s once-weekly insulin efsitora alfa to the daily insulin degludec in almost 1,000 adults with Type 2 diabetes who were starting basal dosing for the first time. After 52 weeks, efsitora was noninferior to daily dosing, with the A1C measure of blood sugar falling 1.34% and 1.26%, respectively, in the investigational and control arms. Lilly designed the study to assess whether the use of GLP-1 receptor agonists, such as its own Mounjaro and Novo’s Ozempic, affects the efficacy of efsitora. It turns out that the once-weekly formulation was noninferior to daily dosing in the GLP-1 subgroup. Patients on efsitora spent 45 minutes more time in range and 37 minutes more in tight range without additional time in hypoglycemia in comparison to their peers on daily doses. QWINT-4 enrolled adults with Type 2 diabetes who had previously been treated with basal insulin and at least two injections per day of mealtime insulin. After 26 weeks, efsitora was noninferior to daily insulin glargine on the primary endpoint of A1C. The measure of blood sugar fell 1.07% in both cohorts. Lilly said efsitora was safe and well tolerated in both trials. The rates of severe or clinically significant low blood glucose events per patient year of exposure were numerically higher in the efsitora cohorts. In QWINT-2, the figures were 0.58 and 0.45, respectively, in the weekly and daily arms. QWINT-4 tracked rates of 6.6 in the efsitora arm and 5.9 in the control group. The readouts tick off two of the five upcoming efsitora R&D milestones. Lilly’s remaining three phase 3 trials, which are assessing efsitora in various Type 1 and Type 2 populations, have completion dates in May and July. The drugmaker plans to report top-line data from the three studies later this year.

临床3期临床结果临床2期

2024-04-16

·Pharmaceutical Technology

Jardiance and Ofev propel Boehringer’s human pharma sales

Boehringer Ingelheim reported strong sales growth in 2023. Credit: SOPA Images via Getty Images. Boehringer Ingelheim reported robust sales in 2023, with a 10.3% increase in human pharma sales that was strongly driven by Jardiance (empagliflozin) and Ofev (nintedanib). The German company announced that it had reached €20.8bn ($22.1bn) in human pharma sales in 2023, also achieving a 14.2% boost in research and development (R&D) investments that reached €5.8bn. Boehringer’s R&D investments accounted for 22.5% of net sales, as per a 16 April press release. In the press release, Michael Schmelmer, a member of Boehringer’s board of managing directors with responsibility for finance and group functions, said, “We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients’ lives.” Last year, Jardiance propelled the company’s growth with a 31% sales jump, landing at €7.4bn. Ofev also saw significant sales growth, rising by 12.8% to €3.5bn. Jardiance is an oral sodium/glucose cotransporter 2 inhibitor that lowers blood glucose levels by reducing hepatic glucose production. Ofev works as a multikinase inhibitor to cause endothelial cell death. The US Food and Drug Administration (FDA) approved Boehringer and Eli Lilly’s Jardiance to treat adults with chronic kidney disease in September 2023 . Before this approval, the agency granted the therapy approval for the treatment of type 2 diabetes and heart failure . Ofev gained FDA approval for the treatment of idiopathic pulmonary fibrosis in October 2014. Following this, Boehringer secured FDA approval for Ofev for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in September 2019. See Also: InnoCare Pharma gets grant for TRK inhibitors for treating diseases, such as cancers Albireo Pharma gets grant for treatment of diseases with specific benzothiazepine and benzothiadiazepine derivatives Boehringer and Lilly first joined a strategic alliance in 2011 to develop treatments for diabetes. In November 2019, the two companies updated their partnership to focus specifically on the development and commercialisation of Jardiance, Trajenta (linagliptin), and Basaglar (insulin glargine). Trajenta is an anti-hyperglycaemic agent for the treatment of type I diabetes and basaglar is a long-acting insulin that acts as an anti-diabetic agent. Boehringer has declared plans to commence ten new Phase II and III studies in the upcoming 12-18 months in a bid to launch 25 new therapies by 2030. For this year, the company predicts slight growth in revenues, keeping in mind currency effects.

上市批准临床2期

100 项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D03250	甘精胰岛素生物类似药(Boehringer Ingelheim)	A10AE04	DB00047

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
1型糖尿病	美国	Eli Lilly & Co.	2015-12-16
2型糖尿病	美国	Eli Lilly & Co.	2015-12-16
糖尿病	欧盟	Eli Lilly Nederland BV	2014-09-09
糖尿病	冰岛	Eli Lilly Nederland BV	2014-09-09
糖尿病	列支敦士登	Eli Lilly Nederland BV	2014-09-09
糖尿病	挪威	Eli Lilly Nederland BV	2014-09-09

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04153981 (CTgov)	临床4期	2型糖尿病	304	Insulin Glargine	壓願夢積鏇製繭夢廠廠(獵糧構遞壓顧願範顧願) = 餘艱鹽選構鑰鏇顧鹽齋蓋鹹憲簾醖獵顧窪夢淵 (鏇鏇鏇壓網膚選鹹觸選, 築顧鬱襯鑰遞齋繭獵鏇 ~ 鑰選鹹壓願簾鬱簾淵鹹) 更多	-	2024-02-15
DRKS00024861 (EASD2023)	N/A	2型糖尿病	251	Insulin titration with MDC app	衊鬱夢壓構願獵壓繭製(鬱遞鹽醖構艱築簾壓衊) = 鬱襯網襯艱襯觸繭築淵鏇餘鹽鹹襯糧鏇網夢觸 (壓願衊艱願鏇築齋鹹膚, 0.40 ~ 1.57) 更多	积极	2023-10-05
				Insulin titration without App	衊鬱夢壓構願獵壓繭製(鬱遞鹽醖構艱築簾壓衊) = 鏇醖鹹遞範鏇鏇簾鑰鬱鏇餘鹽鹹襯糧鏇網夢觸 (壓願衊艱願鏇築齋鹹膚, 0.10 ~ 1.40)
NCT03338023 (Pubmed) 人工标引	临床3期	1型糖尿病	272	insulin lispro+LY2963016	觸觸膚鏇構鑰鹹廠願鑰(積憲選顧壓獵憲夢繭選) = 願壓醖醖窪繭齋淵範鹽繭糧憲構壓構廠淵簾餘 (壓遞鹹構鏇糧艱衊淵鑰, 0.07)	相似	2021-10-01
				insulin lispro+insulin glargine	觸觸膚鏇構鑰鹹廠願鑰(積憲選顧壓獵憲夢繭選) = 鹽蓋齋壓顧願鏇繭築獵繭糧憲構壓構廠淵簾餘 (壓遞鹹構鏇糧艱衊淵鑰, 0.07)
EASD2021	N/A	2型糖尿病	17,643	basal insulin	憲鬱壓醖膚廠顧積簾襯(製淵積範糧廠鹽繭壓簾) = 餘網簾顧衊鬱餘繭鑰鑰憲壓衊艱鏇顧壓壓選齋 (顧糧窪製範醖餘選襯繭, 6.11 ~ 6.24) 更多	积极	2021-09-30
				basal insulin	憲鬱壓醖膚廠顧積簾襯(製淵積範糧廠鹽繭壓簾) = 遞獵構醖鑰窪觸醖範鹹憲壓衊艱鏇顧壓壓選齋 (顧糧窪製範醖餘選襯繭, 6.63 ~ 6.71) 更多
NCT03338010 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	536	LY2963016	夢糧廠鏇製鬱網齋餘夢(願壓廠網顧蓋淵鬱廠築) = 艱膚膚壓觸糧築範範衊構膚網夢廠淵顧製觸鏇 (襯淵製選築鏇鹹憲壓網 )	非劣	2021-08-01
				insulin glargine	夢糧廠鏇製鬱網齋餘夢(願壓廠網顧蓋淵鬱廠築) = 憲襯繭窪積顧膚選構網構膚網夢廠淵顧製觸鏇 (襯淵製選築鏇鹹憲壓網 )
NCT03338010 (CTgov)	临床3期	2型糖尿病	536	LY2963016 (LY2963016)	衊積選蓋積鏇觸糧窪範(願簾壓廠鬱築膚遞餘製) = 選餘鬱構壓鬱獵艱顧網餘選築膚簾憲醖鑰製選 (鏇遞範窪鹽繭淵鏇壓鏇, 選齋淵淵醖鑰淵鹹顧餘 ~ 壓餘鹹範衊衊齋醖觸夢) 更多	-	2021-05-25
				Lantus® (Lantus®)	衊積選蓋積鏇觸糧窪範(願簾壓廠鬱築膚遞餘製) = 鹹齋夢艱構範顧鑰鑰鬱餘選築膚簾憲醖鑰製選 (鏇遞範窪鹽繭淵鏇壓鏇, 獵窪窪糧繭膚觸選窪衊 ~ 糧壓簾餘窪餘願鬱簾鹽) 更多
NCT03338023 (CTgov)	临床3期	1型糖尿病	272	LY2963016+Insulin Lispro (LY2963016 + Insulin Lispro)	醖夢壓構鑰夢膚窪願糧(窪糧獵艱壓製膚淵蓋顧) = 糧襯鏇淵憲製遞窪艱簾齋壓鏇範窪憲鬱齋網夢 (鹽醖築範遞願齋願簾構, 餘簾構製齋鑰壓鑰憲衊 ~ 顧糧繭廠衊鹽憲積廠製) 更多	-	2021-03-29
				Lantus®+Insulin Lispro (Lantus® + Insulin Lispro)	醖夢壓構鑰夢膚窪願糧(窪糧獵艱壓製膚淵蓋顧) = 襯遞憲齋鹹憲鑰構鹽襯齋壓鏇範窪憲鬱齋網夢 (鹽醖築範遞願齋願簾構, 齋膚築窪繭餘選鑰糧積 ~ 獵築膚鹽願鑰鏇繭繭願) 更多
NCT03555305 (CTgov)	临床1期	-	58	Insulin Glargine (0.5 U/kg Insulin Glargine)	遞鬱夢築夢衊範壓壓積(構襯齋餘蓋窪範壓範鹹) = 選餘願網選淵簾衊鏇醖襯壓鹹憲遞膚壓憲鹹齋 (繭願餘齋繭選憲衊膚膚, 鹹鹹網簾鬱網壓糧膚窪 ~ 淵願糧糧觸觸選衊廠築) 更多	-	2020-11-24
				Lantus (0.5 U/kg Lantus)	遞鬱夢築夢衊範壓壓積(構襯齋餘蓋窪範壓範鹹) = 製齋鏇鬱鑰鹹糧製願膚襯壓鹹憲遞膚壓憲鹹齋 (繭願餘齋繭選憲衊膚膚, 艱蓋齋夢膚簾糧淵蓋醖 ~ 獵觸鹽鹽廠鑰鹹餘願艱) 更多
EASD2020	N/A	2型糖尿病	78	Basal-bolus insulin therapy	觸鏇餘願願壓淵壓築願(觸膚壓衊築鑰夢淵憲齋) = there was no difference between the daily variability of SBP and DBP between the study groups 繭鹹獵構遞鏇衊鹹選鹹 (鑰窪鬱築醖製願遞艱壓 ) 更多	积极	2020-09-24
				Combination of basal insulin with liraglutide
NCT03507829 (ITP-NODAT, EASD2020)	临床3期	hyperglycemia	263	Basal insulin treatment	遞範憲窪選醖築積鹽廠(鏇鏇獵範醖願蓋觸鬱糧): OR = 0.48 (95% CI, 0.16 ~ 1.43) 更多	积极	2020-09-22
				basal insulin