INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.

开始日期2023-07-07

申办/合作机构

MannKind Corp.

[+1]

NCT05243628 / Completed临床4期

ABC [Afrezza With Basal Combination]: A Phase 4 Study of Mealtime Control With Afrezza in Adult Subjects With Type 1 Diabetes Mellitus in Combination With an Automated Insulin Pump or Insulin Degludec

MKC-TI-192 is a Phase 4, 90-day, randomized, three-arm, multicenter clinical trial evaluating the treatment paradigm and efficacy of Afrezza in controlling postprandial glucose in adult subjects (≥18 years of age) with Type 1 Diabetes Mellitus (T1DM). Subjects will be randomized to one of three treatment groups (two Afrezza groups and one control group):
Afrezza + AID: Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a continuous subcutaneous insulin infusion (CSII) pump with an automatic insulin delivery (AID) algorithm using rapid acting analogs (RAA) for their basal and correction insulin coverage.
Afrezza + Insulin Degludec: Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage.
AID Control: Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group).
The study is composed of up to 5 clinic visits (screening, 3 treatment visits, and an end-of-treatment visit) and 9 telephone visits.

开始日期2022-03-31

申办/合作机构

MannKind Corp.

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]

100 项与人胰岛素相关的临床结果

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项与人胰岛素相关的文献（医药）

2023-03-01·Diabetes therapy : research, treatment and education of diabetes and related disorders

Time–Action Profile of Technosphere Insulin in Children with Type 1 Diabetes

Article

作者: Kaiserman, Kevin B ; Haller, Michael J ; Jones, Marisa C ; Bhavsar, Sunil

INTRODUCTION:

Technosphere insulin (TI) is an inhaled dry powder ultra-rapid-acting insulin. This report describes the results of the first study of TI in children with type 1 diabetes (T1D).

METHODS:

Pharmacokinetics (PK) of TI and the effect of TI on circulating glucose concentrations were evaluated in a single-arm study that enrolled children ages 8-17 years with T1D for more than 1 year, on a stable multiple daily insulin injection (MDI) regimen, and meeting pre-defined pulmonary function testing criteria (at least 70% predicted). To assess PK, subjects received an individualized single preprandial dose of TI (4-12 U, in 4-U increments) via oral inhalation, based on their usual meal-time subcutaneously injected rapid-acting insulin dose and meal content. Serum insulin and blood glucose were measured at - 30 to 250 min relative to dosing.

RESULTS:

Twenty-seven children with T1D participated in this single-dose PK study. Mean subject age was 13.3 years (59% female; 81.5% White). Mean serum insulin C_max (maximum concentration) was 77.3, 119.15, and 207.7 µU/mL for doses of 4, 8, and 12 U, respectively. T_max occurred at 10.5, 13.9, and 14.6 min post-dose for 4, 8, and 12 U. Glucose lowering 30-60 min post-dose was consistent with the PK profile.

CONCLUSION:

Serum insulin rapidly increased post-dose and returned to baseline by 120 min. The data suggests the PK of TI in youth with T1D ages 8-17 years was similar to that seen in previous adult studies.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT02527265.

2023-01-01·Annals of biomedical engineering

Transforming Evidence Generation for Drug Label Changes: A Case Study

Article

作者: Desborough, Lane ; Ulloa, Johanna ; Kaiserman, Kevin ; Jaffe, Karen ; Hanna, Joseph

Computer Modeling and Simulation (CM&S) provides the opportunity to drastically reduce clinical trial patient burden and advance regulatory decision making. At the suggestion of the US Food and Drug Administration (FDA), MannKind Corporation and Nudge BG submitted an application to the FDA Model-Informed Drug Development (MIDD) pilot program to support a label change for the initial dose of Afrezza® (insulin human), a novel inhalable insulin with a rapid pharmacokinetic and pharmacodynamic profile. The MIDD pilot program demonstrates the FDA's commitment to advancing regulatory science through the adoption of evidence generated by CM&S. A simulation framework was developed based on empirical data. It was used to generate evidence to support the label change. Briefing packages and presentations were prepared for two meetings with the FDA, over a period of four months. The model was thoroughly characterized, determined to be low risk for the question of interest, and submitted along with additional clinical evidence for validation. The FDA found the simulation framework to be helpful in providing insights into the question of interest and provides reasonable glycemic outcome predictions. At the conclusion of the MIDD paired meetings, FDA personnel from the Center for Drug Evaluation and Research review team accepted the simulation and requested additional, traditional clinical evidence to support the proposed label change. In the post-meeting comments, the FDA invited MannKind to submit a proposal for a data package including the CM&S evidence in a Type C meeting for further discussion on the label change. This MIDD pilot experience suggests that CM&S is a credible method for evidence generation. Collaboration between sponsor organizations as well as all stakeholders in the FDA, including proponents of CM&S, can further support regulatory decision-making. The learnings from early participants will allow the program to reach its full potential and thereby ultimately benefit patients, sponsors, and FDA.

2022-03-01·Clinical pharmacokinetics2区 · 医学

Comparison of Pharmacokinetics and Pharmacodynamics of Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro in the Treatment of Type 1 Diabetes Mellitus

2区 · 医学

Article

作者: Baughman, Robert ; Heise, Tim ; Grant, Marshall

BACKGROUND:

This study was performed to satisfy a US Food and Drug Administration post-marketing requirement to compare the dose responses for Technosphere^® Insulin (TI; MannKind Corporation, Westlake Village, CA, USA) and subcutaneous insulin lispro (LIS) across a wide range of doses.

OBJECTIVES:

This single-center, open-label, randomized, cross-over study defined the pharmacokinetic/pharmacodynamic curves for inhaled TI vs subcutaneous LIS in persons with type 1 diabetes mellitus.

METHODS:

Each volunteer received six treatments while undergoing euglycemic clamps: three doses of TI (10, 30 and 120 U) and LIS (8, 30, and 90 U). Primary endpoint was area under the glucose infusion rate vs time curve from start of treatment administration to end of clamp. Key secondary endpoints included readouts of insulin exposure and timing of pharmacokinetic/pharmacodynamic profiles.

RESULTS:

Insulin exposure was more than dose proportional, increasing with dose^1.08 for LIS and dose^1.35 for TI. Time to reach 10% of the maximum glucose infusion rate was 7 to 15 min for TI vs 21 to 38 min for LIS. End of effect was dose dependent for both treatments, ranging from 2 to 6 h (TI) and 5 to 10 h (LIS). Glucose infusion rate exhibited saturation for both treatments. Technosphere Insulin produced a lesser total effect per unit insulin than LIS due to its faster absorption and correspondingly shorter duration of exposure. The difference was large enough to require significantly different doses to achieve the same total effect.

CONCLUSIONS:

Technosphere Insulin has a considerably faster onset and shorter duration of action than LIS. Consequently, the overall effect of TI is smaller than that of LIS and unit-for-unit dose conversion is not appropriate.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02470637; 12 June, 2015.

项与人胰岛素相关的新闻（医药）

2024-06-27

·同写意

诺和诺德是如何赚到第一桶金的？

同写意20周年大会：中国医药创新未来之路！“意”同创新，穿越周期，赢取未来。7月中旬，苏州金鸡湖畔，让我们与“新药写意人”一起为中国医药创新“同写意”！ 1922年，4名来自多伦多的研究员成功从动物胰脏中提取了胰岛素，自此人类找到了针对糖尿病的治疗方案。尽管当时的胰岛素已经能够有效降低人类血糖，但由于该种胰岛素是经由动物碾碎了的胰脏中提取的，产品纯度并不高，极容易引发全身瘙痒、皮疹等副作用，严重者甚至会出现过敏性休克。为了降低动物胰岛素产品的副作用，以礼来为首的胰岛素厂商开启长达60年的“提纯”竞赛。在这场竞赛中，礼来、安万特、诺和等头部公司不断投资，最终成功将胰岛素中的污染物量由最初的50000ppm（ppm，即每百万容量中含有污染物的量）降低至1980年的10ppm。这场胰岛素“提纯”竞赛最终在1982年被画上句号。“基因工程技术先驱”基因泰克公司成功通过大肠杆菌制造重组人胰岛素，并在随后将这项技术授权给了礼来。自此，礼来终于将胰岛素浓度提升至了100%，一切都预示着它即将从这场胰岛素“百年之战”中胜出。但故事的走向并没有如礼来所料的那样发展，反而在这一过程中诞生了它的“一生之敌”诺和诺德。 1 礼来：困于“延续性思维” 大多数技术变革都是沿着一个既定轨道发展的，如在早期的胰岛素赛道，纯度的不断提升就是技术变革的核心路径。对于礼来等头部玩家来说，只要能够不断生产出纯度更高的胰岛素产品，就能更显著地降低副作用率，从而获得更高的产品溢价。正是通过一次又一次的技术迭代，礼来逐渐积累起了竞争优势，因此它才会如此痴迷于“提纯”胰岛素。也就是说，胰岛素赛道早期竞争，是沿着纯度提升这条线延续性发展的。基因泰克克隆的人胰岛素很好地解决了动物胰岛素产生免疫反映的问题，几乎没有了副作用。对于当时的糖尿病患者来说，这是一款完美的产品，但这款完美的产品却并没有给礼来带来充足的回报。为了产业化量产人胰岛素优泌林，礼来在上世纪80年代就投入了近10亿美元资金，寄希望于这款跨时代的产品垄断整个胰岛素市场。因此，礼来给优泌林的定价并不高，仅比常规动物胰岛素提价25%。然而，这款跨时代产品的销售数据却并不佳，礼来甚至发现优泌林很难卖出比动物胰岛素更高的溢价。尽管最终人胰岛素还是全面取代了动物胰岛素，但对比礼来初期的极高投入，这一次“跨时代创新”显然并没有给礼来带来商业化的胜利。剖析优泌林难以形成溢价的原因，正在于“延续性思维”的固化。在产业发展初期，由于动物胰岛素极高的污染物比例，因此纯度是糖尿病人最关心的事情。厂商只要延续这一技术变革路线，就能很轻松地获得商业层面的成功。但“提纯”胰岛素毕竟有一个上限，随着技术的不断精进，业界距离这个上限也就越来越近。至1980年胰岛素纯度已经提升至10ppm，这个纯度几乎已经达到了100%。这时候礼来痴迷于完美的胰岛素产品并没有错，但纯度却早已并不是胰岛素竞争的核心主线了。尽管动物胰岛素仍会导致部分糖尿病患者产生免疫反应，可相对于最初的副作用率已经有了显著降低，动物胰岛素已经可以满足大多数糖尿病患者的需求。在这一基础上，只有产生免疫反应的少部分患者才会去选择价格更高的人胰岛素，而在大多数患者眼中它更像是一种“智商税”。沉迷于“延续性思维”，忽略了胰岛素发展的主要矛盾，这就是为何礼来优泌林当时没有取得预期中成功的原因。产业发展的“第一性”不是一成不变的，而是随着技术变革而不断生变的。 2 诺和诺德：填补临床空白的弯道超车既然礼来错估了胰岛素80年代发展的“第一性”，那么当时糖尿病患者核心痛点到底是什么呢？正是临床未满足需求依从性。当时胰岛素虽然已经能够满足大多数糖尿病患者的降糖需求，但每天注射胰岛素依然是一件较为繁杂的事情。糖尿病患者只能将一次性的在注射器中装满一天的胰岛素，每次注射都需要挤出气泡，并且还要控制好单次注射量。这就使得一次简单的胰岛素注射往往需要花费数分钟时间。今天的人们或许很难感知到当时糖尿病患者的痛苦，这不仅是一种肉体上的痛苦，更是每天小心谨慎注射胰岛素带来的心灵煎熬。这个细微的临床需求切片被丹麦的诺和公司准确洞察，因此在礼来全面推广人胰岛素时，诺和公司（诺和诺德前身）却在尝试通过设计一种更为便捷的注射器来争夺市场。在礼来人胰岛素销售不及预期的1986年，诺和公司成功研发出了新一代胰岛素注射笔——诺和针。诺和针相当于一只特殊设计的钢笔，内含好几周用量的胰岛素，糖尿病人在注射胰岛素时，只需按下注射键，就能在10秒钟内完成胰岛素注射。图：1985年诞生的诺和针，来源：官网与礼来公司苦苦支撑优泌林25%的溢价率不同，诺和公司的诺和针轻松就实现了单位胰岛素30%的销售溢价，直接使得诺和公司胰岛素市场占比大幅提升。借助于诺和针的成功，诺和公司在两年后成功收购了同样来自于丹麦的诺德公司，并在1989年推出了世界上第一个预充型胰岛素注射器NovoLet。依靠诺和针的高度便捷性，合并后的诺和诺德占据了全球54.4%的市场份额，反超礼来成为全球第一。诺和针，正是诺和诺德挖到的第一桶金，这也奠定了诺和诺德后续贴近临床需求的发展策略。 3 小公司如何击败巨无霸？与成功抢下基因泰克人胰岛素的礼来相比，诺和公司只能算得上是一家小公司。但也正是这家小公司，成功抓住了礼来战略失误的契机，最终实现市场占有率的逆袭。无论是品牌层面、技术层面，还是资本层面，礼来都是当时胰岛素赛道的绝对一哥，这样一家大企业究竟为何会失败呢？这实则是一种必然。在产业发展初期，由于没有产品能够满足用户需求对于功能的需求，因此产业竞争的标准就是功能性，也就是胰岛素的纯度。可是当胰岛素纯度提升到一定程度后，市场中大多数的主流胰岛素已经都能够满足用户的需求，因此头部公司的竞争优势就会下降。当产品性能已经足够时，性能的提升就不会带来如之前一样的竞争力，用户关注的焦点也逐渐从功能性转变为便捷性、性价比等其他因素。然而，由于一直以来的行业领先优势，致使龙头公司陷入技术为王的误区，最终导致他们将更多的资金与精力全部投入到更高性能的技术路线上。或许这样的努力在某些时候可以取得成效，但行业终会变化，大公司迟早会因错押技术路线而吃大亏。而那些产业中处于追赶地位的玩家，往往更容易感知到这种变化，所以世界商业史中才总会出现以弱胜强的经典案例。礼来，并不是第一个被逆袭的大公司，也绝不会是最后一个。大公司天生缺少对于技术变革路线迁移的敏感度，而更愿意沿用之前的成功思路，这正是所谓的路径依赖。三十年后，胰岛素已经不再是医药产业竞争的核心战场，但专注于临床未满足需求的诺和诺德依然能够在降糖药物GLP-1中找到减肥的新需求。在GLP-1减肥适应症上，诺和诺德同样展现的是实用主义，在长效GLP-1司美格鲁肽符合用户需求后，开始转而重点研发口服药物，以此提升依从性；而礼来似乎依然秉持着当年完美主义的风格，追求更高的减肥数据，固然换来现阶段全球最高的市值，但依然存在客观风险。只有创新才能带来新机遇，不断填补临床空白的医药产业更是如此。从临床未满足需求出发，企业才能真正捕捉到产业发展过程中的机会，只不过太多的大公司并不愿意去聆听外界声音，而是沉溺于属于自己构建的宏伟叙事之中。万物皆有周期，盛极必衰乃盈虚一定之理。大公司想要维系自身的优势，必须放弃自身大公司定位，而是以产业探索者身份去持续耕耘。医药公司，填补临床空白需求一定是最重要的，无论途径是通过疗效提升、技术迭代，还是依从性提升。近期直播推荐:

医药出海

2024-06-27

·drugs

ADA: Inhaled Insulin Shows Promise for Adults With Type 1 Diabetes

THURSDAY, June 27, 2024 -- Inhaled insulin is associated with improved hemoglobin A1c (HbA1c) levels over 16 weeks among adults with type 1 diabetes when compared to usual care, according to a study presented at the annual meeting of the American Diabetes Association, held from June 21 to 24 in Orlando, Florida. Irl B. Hirsch, M.D., from the University of Washington in Seattle, and colleagues conducted a randomized trial that compared the efficacy of an inhaled insulin regimen (Afrezza) plus degludec insulin (Tresiba) to usual care for 17 weeks among adults with type 1 diabetes treated at 19 U.S. centers. The researchers found that more participants using the inhaled insulin regimen experienced significant improvements in HbA1c levels versus usual care, including 21 percent of those on inhaled insulin with HbA1c improvement >0.5 percent versus 5 percent for those receiving standard care. Among participants with HbA1c level ≥7 percent at baseline, 21 percent of those on inhaled insulin achieved the HbA1c goal of <7 percent, while no participants receiving standard care achieved the goal. Among participants who switched from using an automated insulin delivery system to using inhaled insulin plus degludec, 19 percent achieved an HbA1c improvement >0.5 percent. However, 26 percent of the patients in the inhaled insulin group had a worsening of HbA1c >0.5 percent versus 3 percent receiving standard care. "The INHALE-3 study’s findings will impact diabetes management by providing healthcare providers and patients with an alternative insulin delivery method," Hirsch said in a statement. "These results will assist in better informing clinical decisions and tailoring treatment plans to individual patient needs, potentially improving adherence, patient satisfaction, and overall outcomes." Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果

2024-06-22

·PRNewswire

Study Shows Promising Results for Inhaled Insulin as Treatment for Type 1 Diabetes

Findings Reveal Efficacy of Novel Inhaler to Improve Glycemic Control for Patients with Type 1 Diabetes ORLANDO, Fla., June 22, 2024 /PRNewswire/ -- Today, findings from INHALE-3, a pivotal trial examining the use of inhaled insulin in adults with type 1 diabetes (T1D), were announced, highlighting the potential of an alternative insulin solution to enhance diabetes management. The results were presented as a symposium at the 84th Scientific Sessions of the American Diabetes Association® (ADA) in Orlando, FL. Type 1 diabetes affects 11.6% of the American population and millions of individuals globally, requiring ongoing insulin therapy to manage blood glucose levels. Traditional insulin delivery methods include multiple daily injections or automated insulin delivery systems. However, for some patients, there is a need for new solutions to improve convenience, ease of use, and effective glycemic management. INHALE-3, a randomized trial, compared the efficacy of an inhaled insulin regimen (Afrezza) plus degludec insulin (Tresiba®) against usual care over 17 weeks at 19 centers in the U.S. The trial included 123 adults with type 1 diabetes divided into two groups: one receiving inhaled insulin (Afrezza) plus degludec insulin, and the other continuing their usual care, which included automated insulin delivery systems in about half or multiple daily injections. The study's primary endpoint was a change in HbA1c levels, a critical marker of long-term blood glucose control. Secondary endpoints included changes in time-in-range and hypoglycemia measured with continuous glucose monitoring and patient-reported outcomes on insulin delivery satisfaction. More participants using the inhaled insulin regimen experienced significant improvements in HbA1c levels compared to those on usual care. Notably, 21% of those on inhaled insulin had an HbA1c improvement of greater than 0.5%, while this was seen in only 5% of those with standard care. Furthermore, among participants who had an HbA1c level greater than or equal to 7% at the start of the study, 21% of those on inhaled insulin achieved the HbA1c goal of less than 7% while no participants receiving standard care achieved this HbA1c goal. Nineteen percent of participants who switched from using an automated insulin delivery system to using inhaled insulin plus degludec achieved an HbA1c improvement greater than 0.5%. In contrast to these positive findings, the study found that the insulin regimen with inhaled insulin and degludec was not for everyone: 26% of the patients in the inhaled insulin group had a worsening of HbA1c greater than 0.5% compared with 3% with standard care. Importantly, over half of the study participants wished to continue the inhaled insulin after the study completion. "The INHALE-3 study's findings will impact diabetes management by providing healthcare providers and patients with an alternative insulin delivery method," said Irl B. Hirsch, MD, University of Washington, and lead author of the study. "These results will assist in better informing clinical decisions and tailoring treatment plans to individual patient needs, potentially improving adherence, patient satisfaction, and overall outcomes." Building on the promising results of INHALE-3, further research will focus on the impact of inhaled insulin on a broader patient population, including pediatrics and pregnancy. These studies aim to reinforce the role of inhaled insulin in comprehensive diabetes care. Research presentation details: Dr. Hirsch will present the findings at the following symposium: Symposium: The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Insulin Injections in Adults with Type 1 Diabetes— Results of the INHALE-3 Randomized Trial (Mannkind) Presented on Saturday, June 22, 2024 at 8:00 AM EDT. About the ADA's Scientific Sessions The ADA's 84th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held in Orlando, FL on June 21-24. More than 11,000 leading physicians, scientists, and health care professionals from around the world are expected to convene both in person and virtually to unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Attendees will receive exclusive access to thousands of original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Join the Scientific Sessions conversation on social media using #ADAScientificSessions. About the American Diabetes Association The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For 83 years, the ADA has driven discovery and research to treat, manage, and prevent diabetes while working relentlessly for a cure. Through advocacy, program development, and education we aim to improve the quality of life for the over 136 million Americans living with diabetes or prediabetes. Diabetes has brought us together. What we do next will make us Connected for Life®. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn (American Diabetes Association), Twitter (@AmDiabetesAssn), and Instagram (@AmDiabetesAssn). Contact: Amy Robinson [email protected] SOURCE American Diabetes Association

临床结果

100 项与人胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	人胰岛素	A10AF01 A10AD01 A10AC01	DB00030

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病	美国	MannKind Corp.	2014-06-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胰岛素依赖型糖尿病2	临床3期	美国	MannKind Corp.	2009-03-01
胰岛素依赖型糖尿病2	临床3期	俄罗斯	MannKind Corp.	2009-03-01
胰岛素依赖型糖尿病2	临床3期	乌克兰	MannKind Corp.	2009-03-01
2型糖尿病	临床3期	美国	MannKind Corp.	2009-03-01
2型糖尿病	临床3期	俄罗斯	MannKind Corp.	2009-03-01
2型糖尿病	临床3期	乌克兰	MannKind Corp.	2009-03-01
中度慢性阻塞性肺疾病	临床3期	美国	MannKind Corp.	2009-03-01
中度慢性阻塞性肺疾病	临床3期	俄罗斯	MannKind Corp.	2009-03-01
中度慢性阻塞性肺疾病	临床3期	乌克兰	MannKind Corp.	2009-03-01
哮喘	临床3期	阿根廷	MannKind Corp.	2006-06-01

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临床结果

适应症

分期

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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


NCT05904743 (INHALE-3, Company_Website) 人工标引	临床4期	1型糖尿病	123	Afrezza (insulin human) Inhalation Powder	壓衊選憲觸鹽夢獵膚製(憲醖遞鹹鹽蓋願醖憲襯) = 鑰衊遞製廠繭繭壓窪壓壓鬱遞醖繭醖夢範願獵 (獵憲鬱鹹糧顧糧築糧遞 ) 达到更多	相似	2024-06-22
				Usual care (MDI, AID, or pump without automation)	壓衊選憲觸鹽夢獵膚製(憲醖遞鹹鹽蓋願醖憲襯) = 壓衊簾醖遞範鏇壓願夢壓鬱遞醖繭醖夢範願獵 (獵憲鬱鹹糧顧糧築糧遞 ) 达到更多
NCT04849845 (CTgov)	临床4期	2型糖尿病 \| 胰岛素依赖型糖尿病2	20	insulin+insulin human (Afrezza Dose 1)	獵製糧製築糧蓋繭糧簾(蓋襯簾襯範膚選艱鏇鹹) = 鏇鏇膚鹹獵膚製蓋顧蓋廠鹹構範憲醖遞夢膚願 (簾鬱鑰廠壓願廠艱膚鬱, 廠餘廠夢廠蓋願憲顧築 ~ 顧構觸襯鬱範構襯壓壓) 更多	-	2023-09-18
				insulin+insulin human (Afrezza Dose 2)	獵製糧製築糧蓋繭糧簾(蓋襯簾襯範膚選艱鏇鹹) = 窪淵齋選壓範顧艱願遞廠鹹構範憲醖遞夢膚願 (簾鬱鑰廠壓願廠艱膚鬱, 糧膚壓壓製襯網蓋襯廠 ~ 齋願鏇鑰衊夢遞範淵顧) 更多
NCT02527265 (Pubmed)	临床2期	1型糖尿病	27	Technosphere Insulin	壓顧鑰鹽製獵醖遞膚糧(網願選鬱範膚齋積積選) = 鏇簾壓積簾窪膚網遞構獵壓構願窪遞網糧範艱 (構獵廠顧壓製蓋範憲簾 ) 更多	-	2023-01-18
NCT03143816 (STAT, CTgov)	临床4期	1型糖尿病	60	insulin aspart (Insulin Aspart ( Novolog) -Control Arm)	廠壓構廠壓鑰壓願鹽願(糧淵網製膚簾觸願窪餘) = 齋構淵簾憲鏇遞選廠憲艱憲鏇觸齋構範觸餘鑰 (衊糧齋齋鑰襯繭顧夢範, 繭範獵淵鑰壓淵選憲襯 ~ 鑰繭顧築鏇憲膚壓鏇糧) 更多	-	2022-02-22
				Technosphere insulin (Technosphere Insulin (TI, Afrezza) -Treatment Arm)	廠壓構廠壓鑰壓願鹽願(糧淵網製膚簾觸願窪餘) = 積齋構襯壓範餘憲鹽壓艱憲鏇觸齋構範觸餘鑰 (衊糧齋齋鑰襯繭顧夢範, 網願廠糧鏇築夢獵餘鑰 ~ 築衊選膚鬱積膚簾蓋衊) 更多
NCT02527265 (CTgov)	临床2期	1型糖尿病	30	Afrezza (Technosphere Insulin) (Afrezza Cohort 1 (Ages 13-17))	範鑰獵衊簾夢構網醖餘(構壓願製繭願憲選範醖) = 鏇壓築觸醖淵齋鹹構鏇衊糧選觸窪廠網糧艱構 (齋糧淵顧鹹範憲網簾廠, 窪願醖糧糧鹹製壓衊構 ~ 製餘選醖鏇糧淵構醖醖) 更多	-	2021-04-06
				insulin (Afrezza Cohort 2 (Ages 8-12))	範鑰獵衊簾夢構網醖餘(構壓願製繭願憲選範醖) = 襯衊網繭糧膚積糧遞壓衊糧選觸窪廠網糧艱構 (齋糧淵顧鹹範憲網簾廠, 窪構顧獵膚簾遞製簾壓 ~ 繭衊製繭蓋鑰範鏇廠構) 更多
NCT00309244 \| NCT01445951 \| NCT00539890 \| NCT00700622 \| NCT00308308 (EASD2020)	临床3期	2型糖尿病	-	Technosphere Insulin (TI)	獵願鬱積積鹹糧鹽願製(憲鬱積淵鑰繭獵醖選觸) = 糧蓋製願鹹鏇夢選顧衊網獵夢積鏇襯廠繭顧鏇 (鬱鏇簾廠製醖獵觸膚築, SE)	积极	2020-09-23
				Insulin lispro or aspart	獵願鬱積積鹹糧鹽願製(憲鬱積淵鑰繭獵醖選觸) = 壓積繭壓窪範淵鬱鑰鹹網獵夢積鏇襯廠繭顧鏇 (鬱鏇簾廠製醖獵觸膚築, SE)
NCT03143816 (not provided, EASD2018)	临床4期	1型糖尿病	-	Technosphere insulin (TI)	願夢廠糧積製蓋簾鏇鑰(齋壓膚鹹窪醖齋淵鹹觸) = 簾願餘糧糧顧艱顧鹹壓鬱壓膚壓簾艱鹹願憲餘 (衊積範蓋積鏇襯窪繭憲, 113.5 ± 6.4) 更多	积极	2018-10-03
				Insulin Aspart	願夢廠糧積製蓋簾鏇鑰(齋壓膚鹹窪醖齋淵鹹觸) = 簾艱鏇鬱鑰衊膚願簾遞鬱壓膚壓簾艱鹹願憲餘 (衊積範蓋積鏇襯窪繭憲, 133.8 ± 4.4) 更多
NCT01451398 (Pubmed \| Diabetes Care) 人工标引	临床3期	2型糖尿病	353	Insulin	繭憲遞獵製糧觸積窪積(淵襯襯選窪製簾蓋淵襯) = 蓋鏇窪艱齋衊餘觸繭鬱憲鑰衊觸簾憲鏇鹽淵觸 (憲蓋積窪蓋製衊糧製遞 ) 更多	积极	2015-12-01
				Placebo	繭憲遞獵製糧觸積窪積(淵襯襯選窪製簾蓋淵襯) = 選鏇夢網襯繭鏇鏇鹹範憲鑰衊觸簾憲鏇鹽淵觸 (憲蓋積窪蓋製衊糧製遞 ) 更多
NCT01445951 (Pubmed \| Diabetes Care) 人工标引	临床3期	1型糖尿病	345	Inhaled Technosphere Insulin	鹽醖製淵鬱鬱蓋顧鏇構(積鏇醖襯衊遞衊夢顧壓) = 鹽艱簾積艱遞繭鹽鬱選衊觸憲廠襯製襯鬱顧鹽 (鹽襯網選齋淵鹹夢鏇糧 ) 更多	非优	2015-12-01
				insulin aspart	鹽醖製淵鬱鬱蓋顧鏇構(積鏇醖襯衊遞衊夢顧壓) = 製觸鹽夢醖願遞鏇膚壓衊觸憲廠襯製襯鬱顧鹽 (鹽襯網選齋淵鹹夢鏇糧 ) 更多
NCT01445951 (AFFINITY-1, CTgov)	临床3期	1型糖尿病	518	Gen2 Inhaler (Technosphere ® Insulin-Gen2 Group)	觸鬱築築鏇積鏇壓構夢(膚壓醖衊繭繭選夢鏇鏇) = 願鹹衊壓艱鏇衊襯鹽築範積範廠憲夢醖遞夢夢 (願醖網鏇餘餘築獵憲簾, 襯鹹鹽獵鬱壓構鹽艱鑰 ~ 廠鑰壓觸遞選餘鏇鬱網) 更多	-	2014-10-22
				Technosphere® Insulin (Technosphere® Insulin With MedTone C Inhaler)	觸鬱築築鏇積鏇壓構夢(膚壓醖衊繭繭選夢鏇鏇) = 構齋遞網憲衊衊醖鬱鬱範積範廠憲夢醖遞夢夢 (願醖網鏇餘餘築獵憲簾, 衊淵簾鏇願餘艱餘築觸 ~ 選膚廠願膚構獵鹹獵淵) 更多