- |||||||||| Fiasp (fast-acting insulin aspart) / Novo Nordisk, Afrezza (recombinant human insulin inhalation) / MannKind, Apidra (insulin glulisine) / Sanofi
Review, Journal: Prandial Insulins: A Person-Centered Choice. (Pubmed Central) - May 9, 2024
The Technosphere insulin offers an inhaled route for prandial insulin delivery...Ongoing research is focused on refining prandial insulin replacement and exploring newer delivery methods. The article provides a comprehensive overview of various prandial insulin options and their clinical applications in the management of diabetes.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Enrollment closed, Trial primary completion date, Combination therapy: Afrezza (clinicaltrials.gov) - Mar 5, 2024
P3, N=319, Active, not recruiting,
The article provides a comprehensive overview of various prandial insulin options and their clinical applications in the management of diabetes. Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2024 --> Sep 2024
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Trial completion date, Combination therapy: Afrezza (clinicaltrials.gov) - Jan 5, 2024
P3, N=264, Recruiting,
Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2024 --> Sep 2024 Trial completion date: Apr 2024 --> Apr 2025
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Enrollment closed: INHALE-3: Afrezza (clinicaltrials.gov) - Nov 30, 2023
P4, N=141, Active, not recruiting,
Expected conclusion to include summary of results highlighting the efficacy and safety outcomes. Recruiting --> Active, not recruiting
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Trial primary completion date, Combination therapy: Afrezza (clinicaltrials.gov) - Sep 13, 2023
P3, N=264, Recruiting,
Recruiting --> Active, not recruiting Trial primary completion date: Aug 2023 --> Dec 2023
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Enrollment open: INHALE-3: Afrezza (clinicaltrials.gov) - Jul 6, 2023
P4, N=145, Recruiting,
Trial primary completion date: Aug 2023 --> Dec 2023 Not yet recruiting --> Recruiting
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
New P4 trial: INHALE-3: Afrezza (clinicaltrials.gov) - Jun 15, 2023
P4, N=145, Not yet recruiting,
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Trial primary completion date, Combination therapy: Afrezza (clinicaltrials.gov) - May 8, 2023
P3, N=264, Recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Apr 2023 --> Aug 2023
- |||||||||| Generex Oral-lyn (insulin buccal spray) / Generex, Dong Sung Pharma, Shreya Life Sci, Afrezza (recombinant human insulin inhalation) / MannKind
Journal: Celebrating A Century Of Insulin Discovery: A Critical Appraisal Of The Emerging Alternative Insulin Delivery Systems. (Pubmed Central) - Mar 27, 2023
These efforts have not been without victory, as we have seen the emergence of pulmonary (Exubera and Afrezza) and buccal insulin delivery systems licenced for therapeutic use...However, at present, there are no clinical studies that have reported the efficacy of transdermal insulin administration With technological advancement, there is a potential to develop yet another insulin delivery system which would likely enter the markets. Although these novel delivery systems are welcome, however, emerging competing products should be welcome and appreciated.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Journal: Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes. (Pubmed Central) - Jan 19, 2023
P2
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.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
INHALED INSULIN + AID SAFELY REDUCED GLUCOSE COMPARED TO AID ADMINISTERED RAA FOLLOWING IN-CLINIC MEAL IN PROOF-OF-CONCEPT STUDY DATA SUBSET (Hall A5) - Dec 16, 2022 - Abstract #ATTD2023ATTD_354;
The data suggests the PK of TI in youth with T1D ages 8-17 years was similar to that seen in previous adult studies. Background and Aims:Technosphere Insulin (TI) is anultra-rapid-acting inhaled insulin...The results of this study indicate that TI with ahigher (*2x RAA) converted dose, in combination with an AIDsystem, significantly reduces glucose in the 2-hour postprandialperiod compared to an AID system alone, with no safety signals.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Trial completion, Enrollment change, Combination therapy: Afrezza With Basal Combination (clinicaltrials.gov) - Nov 1, 2022
P4, N=33, Completed,
Background and Aims:Technosphere Insulin (TI) is anultra-rapid-acting inhaled insulin...The results of this study indicate that TI with ahigher (*2x RAA) converted dose, in combination with an AIDsystem, significantly reduces glucose in the 2-hour postprandialperiod compared to an AID system alone, with no safety signals. Recruiting --> Completed | N=25 --> 33
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Journal: Transforming Evidence Generation for Drug Label Changes: A Case Study. (Pubmed Central) - Sep 8, 2022
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...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.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Journal: Reduction in Postprandial Peak Glucose With Increased Technosphere Insulin Dosage. (Pubmed Central) - Jul 15, 2022
The higher dose 2 reduced PPGE versus the current label recommended dose 1 within the two-hour postprandial timeframe without any new safety concerns. When confirmed with a larger study, this higher TI dosing recommendation may help patients and clinicians minimize immediate postprandial hyperglycemia when titrating TI for prandial glucose control.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Trial completion, Enrollment change: Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy (clinicaltrials.gov) - May 25, 2022
P1, N=15, Completed,
When confirmed with a larger study, this higher TI dosing recommendation may help patients and clinicians minimize immediate postprandial hyperglycemia when titrating TI for prandial glucose control. Recruiting --> Completed | N=25 --> 15
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Enrollment open, Combination therapy: Afrezza With Basal Combination (clinicaltrials.gov) - Apr 1, 2022
P4, N=25, Recruiting,
Consequently, the overall effect of TI is smaller than that of LIS and unit-for-unit dose conversion is not appropriate. Not yet recruiting --> Recruiting
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
New P4 trial, Combination therapy: Afrezza With Basal Combination (clinicaltrials.gov) - Feb 17, 2022
P4, N=25, Not yet recruiting,
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Enrollment open, Combination therapy: Afrezza (clinicaltrials.gov) - Sep 21, 2021
P3, N=264, Recruiting,
However, more effective treatments are needed for M. abscessus-PD. Not yet recruiting --> Recruiting
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Trial completion date, Trial primary completion date, Combination therapy: Afrezza (clinicaltrials.gov) - Aug 23, 2021
P3, N=264, Not yet recruiting,
ClinicalTrials.gov: NCT01445951. Trial completion date: Apr 2025 --> Apr 2024 | Trial primary completion date: Apr 2024 --> Apr 2023
- |||||||||| Exubera (recombinant human insulin inhalational) / Nektar Therap, Afrezza (recombinant human insulin inhalation) / MannKind
Journal: Inspiration and Exasperation: The Challenges of Inhaled Biologics. (Pubmed Central) - Aug 1, 2021
As a result, scientific knowledge within the toxicologic pathology community is fragmented with precious little publicly available data. Therefore, one of the aims of this special edition was to generate a collection of manuscripts that pathologists and toxicologists could refer in order to understand the pathology, mechanisms of toxicity, immunogenicity, and challenges associated with the development of inhaled biotherapeutics.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
New P3 trial, Combination therapy: Afrezza (clinicaltrials.gov) - Jul 22, 2021
P3, N=264, Not yet recruiting,
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
PK/PD data, Preclinical, Journal: Excipient-free pulmonary insulin dry powder: Pharmacokinetic and pharmacodynamics profiles in rats. (Pubmed Central) - Jun 22, 2021
PK/PD profiles were measured in rats that received the pulmonary powders by intratracheal insufflation and compared with Afrezza inhalation insulin...In summary, Ins_SD product is suitable for post-prandial glucose control, providing a convenient and compliant product, in particular in the event of using a disposable device. Albeit the product has to be stored in fridge, its stability at room temperature allows the diabetic individual to carry the daily dose in normal conditions.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Trial completion, Trial completion date: Afrezza (clinicaltrials.gov) - Jun 16, 2021
P4, N=20, Completed,
Albeit the product has to be stored in fridge, its stability at room temperature allows the diabetic individual to carry the daily dose in normal conditions. Recruiting --> Completed | Trial completion date: Sep 2021 --> May 2021
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
[VIRTUAL] Inhaled Insulin Improves Daytime Time-in-Range in People with Type 2 Diabetes () - May 29, 2021 - Abstract #ADA2021ADA_1102;
Background and Aims: Technosphere Insulin (TI), an inhaled insulin with ultra-rapid onset and short duration of action that more closely mimics physiologic insulin, may improve patient outcomes... Addition of TI in patients with uncontrolled type 2 diabetes results in a significant increase in daytime CGM time-in-range (from 38.7% to 62.1%, a mean of over 4 hours of increased daytime time-in-range per day) without an increase in hypoglycemia and a significant reduction in both Level 1 and Level 2 hyperglycemia.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
Journal: Effect of Afrezza on Glucose Dynamics During HCL Treatment. (Pubmed Central) - May 4, 2021
Afrezza (A) premeal bolus reduced the early glycemic excursion and improved PPG during HCL compared with aspart premeal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120 min.
- |||||||||| Afrezza (recombinant human insulin inhalation) / MannKind
New P4 trial: Afrezza (clinicaltrials.gov) - Apr 18, 2021
P4, N=20, Recruiting,
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