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.

Start Date07 Jul 2023

Sponsor / Collaborator

MannKind Corp.

[+1]

NCT05243628 / CompletedPhase 4

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.

Start Date31 Mar 2022

Sponsor / Collaborator

MannKind Corp.

NCT04974528 / Active, not recruitingPhase 3

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

Start Date29 Sep 2021

Sponsor / Collaborator

MannKind Corp.

[+1]

100 Clinical Results associated with Insulin Recombinant Human(MannKind)

100 Translational Medicine associated with Insulin Recombinant Human(MannKind)

100 Patents (Medical) associated with Insulin Recombinant Human(MannKind)

Literatures (Medical) associated with Insulin Recombinant Human(MannKind)

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

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

Article

Author: 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.

01 Jan 2023·Annals of biomedical engineering

Transforming Evidence Generation for Drug Label Changes: A Case Study

Article

Author: 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.

01 Mar 2022·Clinical pharmacokineticsQ2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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.

News (Medical) associated with Insulin Recombinant Human(MannKind)

27 Jun 2024

·www.drugs.com

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.

Clinical Result

22 Jun 2024

·www.prnewswire.com

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

Clinical Result

05 Jun 2024

·www.biospace.com

Inhale-3 Study Results to be Presented During a 90-Minute Symposium on Saturday, June 22 at the American Diabetes Association’s 84th Scientific Sessions

17-week endpoint results comparing Afrezza® head-to-head with multiple daily injections (MDI) and insulin pumps INHALE-3 Study Protocol Chair Dr. Irl. B. Hirsh joined by investigational team to deliver presentation moderated by Jaeb Center founder Dr. Roy W. Beck DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced that the 17-week endpoint results from the INHALE-3 study will be presented during a 90-minute symposium and livestream on Saturday, June 22, at the American Diabetes Association’s (ADA) 84th Scientific Sessions. The presentation will be delivered by INHALE-3 Study Protocol Chair Dr. Irl B. Hirsh and the investigational team and will be moderated by Jaeb Center founder Dr. Roy W. Beck. “We are excited for the first read-out of results from the largest post-market clinical trial MannKind has conducted with Afrezza in the last 10 years,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “The results will speak to the common question about Afrezza: ‘How does inhaled insulin fare when compared head-to-head with usual care?’ The full 30-week results of INHALE-3 will be available later this year.” Title: The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Injections in Adults with Type 1 Diabetes Date: Saturday, June 22, 2024 Times: 8:00-9:30 AM (ET) with topics/presenters to include: Inhaled Insulin’s History and Study Rationale – Dr. Halis Akturk Study Methods & Participant Baseline Characteristics – Dr. Yogish Kudva Study Results I: Comparison of Inhaled Insulin vs. Rapid Acting Analogue Insulin in Users of AID or MDI During Standardized In-Clinic Meal Challenge –Dr. Ruth S. Weinstock Study Results II: Primary Efficacy, Safety, and Quality of Life Outcomes – Dr. Carol J. Levy Study Results III: Effect of Inhaled Insulin-Degludec Compared with AID and in Subgroups According to Participant Characteristics – Dr. Grazia Aleppo Critique of Study Design and Results – by Dr. Irl B. Hirsch Use of Afrezza in Clinical Practice – by Dr. Thomas Blevins Question and Answer Session – Moderated by Dr. Roy W. Beck Location: W320 Chapin Theatre at the Orange County Convention Center (+livestream) Livestream: Please refer to for access details MannKind will host booth# 1307 in the Exhibit Hall throughout the Scientific Sessions as well. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth. About MannKind MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking Statements This press release contains forward-looking statements about the release of data from a clinical study that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of an investigational drug product may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. AFREZZA and MANNKIND are registered trademarks of MannKind Corporation. For MannKind: Christie Iacangelo, Corporate Communications (818) 292-3500 Email: media@mnkd.com Rose Alinaya, Investor Relations (818) 661-5000 Email: ir@mnkd.com

100 Deals associated with Insulin Recombinant Human(MannKind)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Insulin Recombinant Human(MannKind)	A10AF01 A10AD01 A10AC01	DB00030

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	US	MannKind Corp.	27 Jun 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	US	MannKind Corp.	01 Mar 2009
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	RU	MannKind Corp.	01 Mar 2009
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	UA	MannKind Corp.	01 Mar 2009
Diabetes Mellitus, Type 2	Phase 3	US	MannKind Corp.	01 Mar 2009
Diabetes Mellitus, Type 2	Phase 3	RU	MannKind Corp.	01 Mar 2009
Diabetes Mellitus, Type 2	Phase 3	UA	MannKind Corp.	01 Mar 2009
Moderate chronic obstructive pulmonary disease	Phase 3	US	MannKind Corp.	01 Mar 2009
Moderate chronic obstructive pulmonary disease	Phase 3	RU	MannKind Corp.	01 Mar 2009
Moderate chronic obstructive pulmonary disease	Phase 3	UA	MannKind Corp.	01 Mar 2009
Asthma	Phase 3	AR	MannKind Corp.	01 Jun 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05904743 (INHALE-3, Company_Website) Manual	Phase 4	Diabetes Mellitus, Type 1	123	Afrezza (insulin human) Inhalation Powder	osmcwfjwwq(xmjfvnkceh) = ofrgngaazh nctedzgzmv (hpojauhofd ) Met View more	Similar	22 Jun 2024
				Usual care (MDI, AID, or pump without automation)	osmcwfjwwq(xmjfvnkceh) = ojnawlzvld nctedzgzmv (hpojauhofd ) Met View more
NCT04849845 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Insulin-Dependent, 2	20	insulin+insulin human (Afrezza Dose 1)	modkcnlhuq(yfeujrrnnt) = hnbaprpaac qgtjeoicxa (qknlzvuzxz, dvajmfcvqi - nklbhlraly) View more	-	18 Sep 2023
				insulin+insulin human (Afrezza Dose 2)	modkcnlhuq(yfeujrrnnt) = wnifzivtec qgtjeoicxa (qknlzvuzxz, pnvrpyfrkq - saxamhzquv) View more
NCT02527265 (Pubmed)	Phase 2	Diabetes Mellitus, Type 1	27	Technosphere Insulin	vyleqerhit(fmxxhyqulx) = njjgtsygbf jkkaoyjoeq (woguclupnd ) View more	-	18 Jan 2023
NCT03143816 (STAT, CTgov)	Phase 4	Diabetes Mellitus, Type 1	60	insulin aspart (Insulin Aspart ( Novolog) -Control Arm)	lfxohpvzob(tcdiqgjmkr) = vhmfwhlfbn yoyozatryo (owyyuyjygp, jaqqnrzoen - pgglabhhsk) View more	-	22 Feb 2022
				Technosphere insulin (Technosphere Insulin (TI, Afrezza) -Treatment Arm)	lfxohpvzob(tcdiqgjmkr) = apbcaiiyeo yoyozatryo (owyyuyjygp, jyuvfuntxd - bhuawlnphn) View more
NCT02527265 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	30	Afrezza (Technosphere Insulin) (Afrezza Cohort 1 (Ages 13-17))	jxghjbbfvf(tjmwgwfdyx) = qvaisxcdnu ikkaphmakz (vxsmvguhrk, ngbhkmiikd - nwnscsfslm) View more	-	06 Apr 2021
				insulin (Afrezza Cohort 2 (Ages 8-12))	jxghjbbfvf(tjmwgwfdyx) = acxafoxnet ikkaphmakz (vxsmvguhrk, libpxgifcu - mwxgoxtxca) View more
NCT00309244 \| NCT01445951 \| NCT00700622 \| NCT00539890 \| NCT00308308 (EASD2020)	Phase 3	Diabetes Mellitus, Type 2	-	Technosphere Insulin (TI)	givvpqxvxl(edoxkxmycb) = ijunjtoshi mlfsamjkow (aynzadofns, SE)	Positive	23 Sep 2020
				Insulin lispro or aspart	givvpqxvxl(edoxkxmycb) = myzgesrmbz mlfsamjkow (aynzadofns, SE)
NCT03143816 (not provided, EASD2018)	Phase 4	Diabetes Mellitus, Type 1	-	Technosphere insulin (TI)	cqekrafzhs(udkagmllvb) = sqdjafwlpw dpazdullid (fkrumbqtel, 113.5 ± 6.4) View more	Positive	03 Oct 2018
				Insulin Aspart	cqekrafzhs(udkagmllvb) = imiolnlcij dpazdullid (fkrumbqtel, 133.8 ± 4.4) View more
NCT01445951 (Pubmed \| Diabetes Care) Manual	Phase 3	Diabetes Mellitus, Type 1	345	Inhaled Technosphere Insulin	myfiqpwzhx(bsknligzij) = ckkfupuxwp ahmmreeqou (wzdiviwwaf ) View more	Non-superior	01 Dec 2015
				insulin aspart	myfiqpwzhx(bsknligzij) = yjnhdxiipw ahmmreeqou (wzdiviwwaf ) View more
NCT01451398 (Pubmed \| Diabetes Care) Manual	Phase 3	Diabetes Mellitus, Type 2	353	Insulin	zzanughich(zjwjogmsbc) = onxgtyjjyo euzwaqindm (vlmcnwsreu ) View more	Positive	01 Dec 2015
				Placebo	zzanughich(zjwjogmsbc) = biljvhrkqc euzwaqindm (vlmcnwsreu ) View more
NCT01445951 (AFFINITY-1, CTgov)	Phase 3	Diabetes Mellitus, Type 1	518	Gen2 Inhaler (Technosphere ® Insulin-Gen2 Group)	fdabwgrdaj(bkmhwooovk) = hdinkowxvt aukirvxult (nixzkgckpc, pwvexohtss - njkgttwhcq) View more	-	22 Oct 2014
				Technosphere® Insulin (Technosphere® Insulin With MedTone C Inhaler)	fdabwgrdaj(bkmhwooovk) = umwexucrpd aukirvxult (nixzkgckpc, vtzvgvxecd - dkgnlmpiqs) View more

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