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Inhaled Insulin

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1. Improved Postprandial Glucose with Inhaled Technosphere Insulin Compared with Insulin Aspart in Patients with Type 1 Diabetes on Multiple Daily Injections: The STAT Study (PubMed)

Improved Postprandial Glucose with Inhaled Technosphere Insulin Compared with Insulin Aspart in Patients with Type 1 Diabetes on Multiple Daily Injections: The STAT Study The majority of therapies have generally targeted fasting glucose control, and current mealtime insulin therapies have longer time action profiles than that of endogenously secreted insulin. The primary purpose of this study was to assess both glucose time-in-range (TIR: 70-180 mg/dL) and postprandial glucose excursions (PPGE (...) ) in 1-4 h using a real-time continuous glucose monitor (CGM) with Technosphere insulin (TI) versus insulin aspart in patients with type 1 diabetes (T1DM) on multiple daily injections (MDI).This pilot, investigator-led, collaborative, open-label, multicenter, clinical research trial enrolled 60 patients with T1DM with HbA1c levels ≥6.5% and ≤10%. Individuals were randomized to treatment with titrated TI (n = 26) or titrated insulin aspart (n = 34), stratified by baseline HbA1c levels (≤8% or >8

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2018 Diabetes technology & therapeutics

2. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. (PubMed)

Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. The Follow-Up Study of patients previously enrolled in Exubera controlled clinical trials (FUSE) was designed to evaluate whether patients previously treated with Exubera (EXU; insulin human [rDNA origin], inhaled powder) in controlled clinical trials died because of incident primary lung cancer at a substantially higher

2019 Diabetes Care

3. Inhaled Insulin - Current Direction of Insulin Research (PubMed)

Inhaled Insulin - Current Direction of Insulin Research Diabetes Mellitus (DM) is a metabolic disorder characterized by relative or absolute deficiency of insulin, resulting in hyperglycemia. Subcutaneous insulin and Oral Hypoglycaemic Agents (OHA) constitute the main treatment option for DM. Insulin is administered by injection or continuous infusion to control glucose levels mainly in Type I diabetes. Newer routes both oral and non oral, for insulin administration are current direction (...) of insulin research as insulin injection therapy is burdensome and painful for many patients. Inhalational insulin is an attractive alternative for systemic administration of insulin given its accessibility and large alveolar-capillary network of lungs for drug absorption. Afrezza, inhaled insulin has been recently approved by Food and Drug Administration (FDA). It is a new, quicker acting inhalable insulin with a different and safer pharmacokinetic profile in comparison to previously failed inhaled form

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2017 Journal of clinical and diagnostic research : JCDR

4. Efficacy of inhaled Technosphere® insulin: a comparative review to injectable insulin

Efficacy of inhaled Technosphere® insulin: a comparative review to injectable insulin "Efficacy of inhaled Technosphere® insulin: a comparative review to inj" by Brian Johnston < > > > > > Title Author Date of Graduation Summer 8-9-2014 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies Rights . Abstract Background: Insulin therapy is often met with apprehension among diabetic patients due to the inconvenience and discomfort of injecting oneself. Past (...) attempts to develop an inhaled insulin has been met with such obstacles as inefficiency, cost issues, and patient acceptance. Technosphere® insulin (MannKind Corporation, Valencia, CA) is a rapid acting inhalable insulin that is indicated for prandial use and is currently in phase III clinical trials. It is showing promising results and this systematic review aims to evaluate the efficacy of Technosphere insulin as compared to traditional injectable insulin. Methods: An exhaustive search was conducted

2014 Pacific University EBM Capstone Project

5. Inhaled insulin: An Elusive Revolution in Diabetes Management

Inhaled insulin: An Elusive Revolution in Diabetes Management Inhaled insulin: An Elusive Revolution in Diabetes Management. – Clinical Correlations Search Inhaled insulin: An Elusive Revolution in Diabetes Management. June 19, 2014 6 min read By Reed Magleby, MD Peer Reviewed For many with type II diabetes, initiation of insulin therapy represents a devastating progression of their disease. Patients who are dependent on insulin require constant blood sugar monitoring, adherence to strict (...) dosing algorithms, and up to 4 self-administered injections every day. According to a 2010 survey of non-insulin adherent diabetic patients, both “injection phobia” . [1]. In response to these concerns, less invasive administration techniques such as inhaled insulin have been a topic of major interest over the last decade. Accepting inhaled insulin as a replacement for injectable could revolutionize the management of type II diabetes and improve the lives of millions of Americans suffering from

2014 Clinical Correlations

6. Good Things in Small Packages: an Innovative Delivery Approach for Inhaled Insulin. (PubMed)

Good Things in Small Packages: an Innovative Delivery Approach for Inhaled Insulin. The design development of a small, hand held, battery operated, breath actuated inhaler as a drug/device platform for inhaled insulin posed a number of technical challenges. Our goal was to optimize lung deposition and distribution with aerosol generators producing 3-6 μm particle size distribution.In silico modeling with computational fluid dynamics (CFD) and in vitro testing of device components were assessed (...) reduced the delivery efficiencg. Prototypes tested with inspiratory flow of 10 L/min provided up to 70% of dose delivered distal to the model throat with aerosols of 3 to 6 μm. Users guided by LED were able to inhale for 8-24 s with 5 s breath hold. Lung dose >70% with peripheral to central ratios >2.0 were achieved, with subject preference for the longer inspiratory time with breath hold.The device design phase integration led to a novel design and inspiratory pattern with greater levels

2018 Pharmaceutical research

7. Rethinking the Viability and Utility of Inhaled Insulin in Clinical Practice (PubMed)

Rethinking the Viability and Utility of Inhaled Insulin in Clinical Practice Despite considerable advances in pharmacotherapy and self-monitoring technologies in the last decades, a large percentage of adults with diabetes remain unsuccessful in achieving optimal glucose due to suboptimal medication adherence. Contributors to suboptimal adherence to insulin treatment include pain, inconvenience, and regimen complexity; however, a key driver is hypoglycemia. Improvements in the PK/PD (...) administration of rapid-acting insulin analogs. This article reviews the unique PK/PD properties of a novel inhaled formulation that support its use in patient populations with T1D or T2D.

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2018 Journal of diabetes research

8. Impact of symptomatic upper respiratory tract infections on insulin absorption and action of Technosphere inhaled insulin (PubMed)

Impact of symptomatic upper respiratory tract infections on insulin absorption and action of Technosphere inhaled insulin Uncomplicated, acute upper respiratory tract infections (URTIs) occur in patients with diabetes at a similar frequency to the general population. This study (NCT00642681) investigated the effect of URTIs on the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Technosphere inhaled insulin (TI) in patients with type 1 or type 2 diabetes.This was a phase 2 study (...) with TI had no significant impact on the PK/PD properties of TI, suggesting that no adjustment in prandial insulin dosing is needed. However, if patients are unable to conduct proper inhalation, they should administer their prandial insulin subcutaneously.NCT00642681; Results.

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2016 BMJ open diabetes research & care

9. A Population Dose–Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects (PubMed)

A Population Dose–Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects Technosphere insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. A euglycemic glucose clamp study was performed to compare the effects of TI and regular human insulin (RHI) on the induced glucose infusion rate (GIR) in healthy volunteers. Generation of a dose-response relationship between insulin dose and effect (expressed

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2017 CPT: pharmacometrics & systems pharmacology

10. Insulin in a Pill: Barriers to Development of Oral Insulin

with their associated costs. Although transmucosal insulin does not face gastrointestinal absorption barriers, the fate of Afrezza, an FDA-approved inhaled insulin, might serve as an industrywide warning. Past inhaled insulins have failed on the market, due to bulkiness and pulmonary side effects, mandating periodic pulmonary function tests to confirm safe drug continuation. Afrezza is no different, making it an expensive treatment that requires patients to undergo extra testing and is contraindicated in patients (...) Insulin in a Pill: Barriers to Development of Oral Insulin Insulin in a Pill: Barriers to Development of Oral Insulin – Clinical Correlations Search Insulin in a Pill: Barriers to Development of Oral Insulin May 8, 2018 4 min read By Nicolas Gillingham Peer Reviewed Over 30 million Americans—9.4% of the population—live with diabetes, .[1] Insulin can be self-administered by subcutaneous injection, either classically via a syringe, an insulin pen, or using an insulin pump. However, patients

2018 Clinical Correlations

11. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial (PubMed)

Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes.This open-label noninferiority trial compared the change in HbA1c from baseline to week 24 of prandial TI (n = 174) with that of subcutaneous aspart (n = 171), both with basal insulin, in patients with type 1 diabetes and HbA1c 7.5-10.0% (56.8-86.0 mmol/mol).Mean (...) (P = 0.0102). TI patients had a lower hypoglycemia event rate than aspart patients (9.8 vs. 14.0 events/patient-month, P < 0.0001). Cough (generally mild) was the most frequent adverse event (31.6% with TI, 2.3% with aspart), leading to discontinuation in 5.7% of patients. Treatment group difference for mean change from baseline in forced expiratory volume in 1 s was small (40 mL) and disappeared upon TI discontinuation.In patients with type 1 diabetes receiving basal insulin, HbA1c reduction

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2015 EvidenceUpdates

12. Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. (PubMed)

Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. To investigate the efficacy and safety of prandial Technosphere inhaled insulin (TI), an inhaled insulin with a distinct time action profile, in insulin-naïve type 2 diabetes (T2D) inadequately controlled on oral antidiabetes agents (OADs).Subjects with T2D with HbA1c levels ≥7.5% (58.5 mmol/mol) and ≤10.0% (86.0 mmol/mol (...) ) on metformin alone or two or more OADs were randomized to add-on prandial TI (n = 177) or prandial Technosphere inhaled placebo (TP) (n = 176) to their OAD regimen in this double-blind, placebo-controlled trial. Primary end point was change in HbA1c at 24 weeks.TI significantly reduced HbA1c by -0.8% (-9.0 mmol/mol) from a baseline of 8.3% (66.8 mmol/mol) compared with TP -0.4% (-4.6 mmol/mol) (treatment difference -0.4% [95% CI -0.57, -0.23]; P < 0.0001). More TI-treated subjects achieved an HbA1c ≤7.0

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2015 Diabetes Care

13. Pharmacokinetic and Pharmacodynamic Properties of a Novel Inhaled Insulin (PubMed)

Pharmacokinetic and Pharmacodynamic Properties of a Novel Inhaled Insulin Advances in insulin treatment options over recent decades have markedly improved the management of diabetes. Despite this, glycemic control remains suboptimal in many people with diabetes. Although postprandial glucose control has been improved with the development of subcutaneously injected rapid-acting insulin analogs, currently available insulins are not able to fully mimic the physiological time-action profile (...) these, pulmonary insulin delivery has shown the most promise. Technosphere® Inhaled Insulin (TI) is a rapid-acting inhaled human insulin recently approved by the FDA for prandial insulin therapy. In this article we discuss the pharmacokinetic and pharmacodynamic properties of TI, and, based on key studies performed during its clinical development, the implications for improved postprandial glucose control.

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2016 Journal of diabetes science and technology

14. Commentary: Why Was Inhaled Insulin a Failure in the Market? (PubMed)

Commentary: Why Was Inhaled Insulin a Failure in the Market? 27574374 2016 08 30 2018 11 13 1040-9165 29 3 2016 Aug Diabetes spectrum : a publication of the American Diabetes Association Diabetes Spectr Commentary: Why Was Inhaled Insulin a Failure in the Market? 180-4 10.2337/diaspect.29.3.180 Oleck Jacob J Becton Dickinson and Company, Franklin Lakes, NJ; School of Pharmacy, MCPHS University, Boston, MA. Kassam Shahista S Becton Dickinson and Company, Franklin Lakes, NJ; School of Pharmacy

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2016 Diabetes spectrum : a publication of the American Diabetes Association

15. Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Pharmacologic (...) Response and Safety of Inhaled Insulin in Type 1 Diabetes (Samba-01) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02713841 Recruitment Status : Completed First Posted : March 21, 2016 Last Update Posted : March 21, 2016 Sponsor: Dance Biopharm Inc. Information provided by (Responsible Party): Dance

2016 Clinical Trials

16. Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes

Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Dose-Response (...) and Variability of Inhaled Insulin in Type 2 Diabetes (Samba-02) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02716610 Recruitment Status : Completed First Posted : March 23, 2016 Last Update Posted : March 23, 2016 Sponsor: Dance Biopharm Inc. Information provided by (Responsible Party): Dance Biopharm Inc

2016 Clinical Trials

17. Subacute Inhalation Exposure to Ozone Induces Systemic Inflammation but not Insulin Resistance in a Diabetic Mouse Model (PubMed)

Subacute Inhalation Exposure to Ozone Induces Systemic Inflammation but not Insulin Resistance in a Diabetic Mouse Model Epidemiological studies suggest that diabetics may be more susceptible to the adverse health effects from exposure to high ambient concentrations of ozone, the primary oxidant gas in photochemical smog. While increased morbidity and mortality from ozone inhalation has been linked to disruption of normal cardiovascular and airway functions, potential effects on glucose (...) results show that in addition to marked local and systemic inflammation, ozone increases insulin sensitivity that may be related to weight loss/leptin sensitization-dependent mechanisms in KKAy mice, warranting further study on the role of hyperglycemia in mediating cardiometabolic effects of ozone inhalation.

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2016 Inhalation toxicology

18. Inhaled Insulin

Inhaled Insulin Inhaled Insulin Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Inhaled Insulin Inhaled Insulin Aka: Inhaled Insulin (...) , Insulin Inhalation Powder , Exubera , Afrezza From Related Chapters II. Background Exubera (listed for historical reasons) Off U.S. Market as of October 2007 (based on business decisions, not on recall) III. Indications when intollerant to SQ injection IV. Contraindications use V. Mechanism Dry powder form of rapid acting Delivery by oral inhalation Large doses needed due to inefficient absorption Most remains in lung and is inactive VI. Preparations: Afrezza Released in 2014, as a substitute Does

2018 FP Notebook

19. Place of technosphere inhaled insulin in treatment of diabetes (PubMed)

Place of technosphere inhaled insulin in treatment of diabetes Technosphere insulin (TI), Afrezza, is a powder form of short-acting regular insulin taken by oral inhalation with meals. Action of TI peaks after approximately 40-60 min and lasts for 2-3 h. TI is slightly less effective than subcutaneous insulin aspart, with mean hemoglobin A1c (HbA1c) reduction of 0.21% and 0.4%, respectively. When compared with technosphere inhaled placebo, the decrease in HbA1c levels was 0.8% and 0.4% with TI (...) and placebo, respectively. Compared with insulin aspart, TI is associated with lower risk of late post-prandial hypoglycemia and weight gain. Apart from hypoglycemia, cough is the most common adverse effect of TI reported by 24%-33% of patients vs 2% with insulin aspart. TI is contraindicated in patients with asthma and chronic obstructive pulmonary disease. While TI is an attractive option of prandial insulin, its use is limited by frequent occurrence of cough, need for periodic monitoring of pulmonary

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2016 World journal of diabetes

20. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. (PubMed)

Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes.This open-label noninferiority trial compared the change in HbA1c from baseline to week 24 of prandial TI (n = 174) with that of subcutaneous aspart (n = 171), both with basal insulin, in patients with type 1 diabetes and HbA1c 7.5-10.0% (56.8-86.0 mmol/mol).Mean (...) (P = 0.0102). TI patients had a lower hypoglycemia event rate than aspart patients (9.8 vs. 14.0 events/patient-month, P < 0.0001). Cough (generally mild) was the most frequent adverse event (31.6% with TI, 2.3% with aspart), leading to discontinuation in 5.7% of patients. Treatment group difference for mean change from baseline in forced expiratory volume in 1 s was small (40 mL) and disappeared upon TI discontinuation.In patients with type 1 diabetes receiving basal insulin, HbA1c reduction

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2015 Diabetes Care

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