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Jeremy Pettus, Tricia Santos Cavaiola, Steven V Edelman
Treatment with Afrezza® (insulin human) inhalation powder in individuals with type 1 diabetes (T1D) reduces HbA1c levels similar to rapid-acting insulin analogs, but with significantly less hypoglycemia due to its unique time action profile. Examinations of studies of Afrezza pharmacokinetics/pharmacodynamics, relevant clinical trials, and U.S. Food and Drug Administration (FDA) documentation suggest that current FDA-mandated dosing recommendations for initiating Afrezza treatment may not result in optimal glycemic control for individuals with T1D...
June 14, 2018: Diabetes Technology & Therapeutics
Wilbur de Kruijf, Carsten Ehrhardt
Oral inhalation offers the opportunity of targeting drugs locally to different regions of the respiratory tract or alternatively, using the high surface area of the alveoli for systemic delivery. Pulmozyme and the inhaled insulins (i.e. Exubera and Afrezza) are examples of the scope of pulmonary drug delivery of biopharmaceuticals-albeit with strikingly different commercial success. Particularly, the failure of Exubera and the subsequent overreactions (e.g. the unsubstantiated lung cancer fear), lastingly stunned the field of systemically inhaled protein and peptide drugs...
October 2017: Current Opinion in Pharmacology
Rashmi Ranjan Mohanty, Smita Das
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...
April 2017: Journal of Clinical and Diagnostic Research: JCDR
Douglas B Muchmore
Considerable progress in treatment of diabetes has been made in the nearly 100 years following the discovery of insulin, and advances in insulin therapy have improved convenience, quality of life, overall glycemic control (A1C), and risk of hypoglycemia. An unmet need remains for a mealtime insulin that can faithfully reproduce the metabolic profile that ensues following meal ingestion in healthy persons. A number of "ultra-fast" insulin programs have been initiated, and Afrezza® (insulin human; Inhalation Powder, MannKind Corporation, Danbury, CT) stands as the first such product to be approved by the US FDA...
January 2017: Journal of Diabetes Science and Technology
Nasser Mikhail
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...
December 15, 2016: World Journal of Diabetes
Nasser Mikhail
BACKGROUND: Technoshere insulin (TI), Afrezza, is a form of short-acting human insulin taken by oral inhalation with meals. METHODS: literature search (English, French, Spanish) of all human studies and pertinent animal and in-vitro studies related to technosphere insulin until September 2016 with special emphasis on its safety. RESULTS: Compared to subcutaneous insulin aspart, TI is slightly less effective, the difference in hemoglobin A1c (HbA1c) reduction being 0...
2017: Current Drug Safety
Janet B McGill, David Ahn, Steven V Edelman, C Rachel Kilpatrick, Tricia Santos Cavaiola
UNLABELLED: Glycemic control is fundamental to the management of diabetes. However, studies suggest that a significant proportion of people with diabetes, particularly those using insulin, are not achieving glycemic targets. The reasons for this are likely to be multifactorial. The real and perceived risk of hypoglycemia and the need for multiple daily injections are widely recognized as key barriers to effective insulin therapy. Therefore, there is a clear unmet need for a treatment option which can help mitigate these barriers...
August 2016: Advances in Therapy
Roberto Visentin, Clemens Giegerich, Robert Jäger, Raphael Dahmen, Anders Boss, Marshall Grant, Chiara Dalla Man, Claudio Cobelli, Thomas Klabunde
BACKGROUND: Technosphere(®) insulin (TI), an inhaled human insulin with a fast onset of action, provides a novel option for the control of prandial glucose. We used the University of Virginia (UVA)/Padova simulator to explore in-silico the potential benefit of different dosing regimens on postprandial glucose (PPG) control to support the design of further clinical trials. Tested dosing regimens included at-meal or postmeal dosing, or dosing before and after a meal (split dosing). METHODS: Various dosing regimens of TI were compared among one another and to insulin lispro in 100 virtual type-1 patients...
September 2016: Diabetes Technology & Therapeutics
Loretta Fala
No abstract text is available yet for this article.
March 2015: American Health & Drug Benefits
Tamara Goldberg, Elaine Wong
Afrezza (insulin human) inhalation powder: a new inhaled insulin for the management of type-1 or type-2 diabetes mellitus.
November 2015: P & T: a Peer-reviewed Journal for Formulary Management
Esther S Kim, Greg L Plosker
Afrezza® (insulin human) inhalation powder is a rapid-acting Technosphere® insulin (TI) administered via a breath-powered oral inhaler to patients with diabetes requiring prandial insulin. TI, a dry powdered formulation of recombinant human insulin adsorbed onto a proprietary carrier, is designed to deliver insulin to the deep lung, at the level of the alveoli, where it is absorbed into the systemic circulation. In a randomized, open-label, multinational, phase III trial (trial 171) in type 1 diabetes (T1DM) patients, prandial TI via the Gen2 inhaler provided noninferior glycated haemoglobin (HbA1c) lowering compared with prandial subcutaneous insulin aspart...
September 2015: Drugs
Moawia M Al-Tabakha
The current review was designed to compare between the insulin inhalation systems Exubera and Afrezza and to investigate the reasons why Exubera was unsuccessful, when Afrezza maker is expecting their product to be felicitous. In January 2006, Pfizer secured FDA and EC approval for the first of its kind, regular insulin through Exubera inhaler device for the management of types 1 and 2 diabetes mellitus (DM) in adults. The product was no longer available to the market after less than two years from its approval triggering a setback for competitive new inhalable insulins that were already in various clinical development phases...
October 10, 2015: Journal of Controlled Release: Official Journal of the Controlled Release Society
Grace Ledet, Richard A Graves, Levon A Bostanian, Tarun K Mandal
PURPOSE: The pharmacologic properties of a recently approved inhaled insulin product, its unique delivery system, and the results of clinical safety and efficacy trials are reviewed. SUMMARY: Afrezza (also called Technosphere Insulin, MannKind Corporation, Valencia, CA) is a novel ultrarapid-acting insulin formulation indicated for use in improving glycemic control in selected patients with type 1 or type 2 diabetes mellitus. Afrezza is not intended as a substitute for traditional basal therapy with injectable long-acting insulin but may be used to provide prandial insulin coverage; it must be used in combination with long-acting insulin in patients with type 1 diabetes...
July 15, 2015: American Journal of Health-system Pharmacy: AJHP
(no author information available yet)
No abstract text is available yet for this article.
June 2, 2015: JAMA: the Journal of the American Medical Association
(no author information available yet)
No abstract text is available yet for this article.
July 2014: American Journal of Managed Care
Laurie W Fleming, Joshua W Fleming, Courtney S Davis
PURPOSE: The purpose of this article is to educate nurse practitioners about Afrezza. DATA SOURCES: A comprehensive literature search was conducted using MEDLINE for clinical trial data. Information from the Centers of Disease Control and Prevention, World Health Organization, clinical guidelines, Food and Drug Administration labeling, briefings, and press releases was also utilized. CONCLUSIONS: Afrezza represents a promising noninjectable insulin delivery option for type 1 and type 2 diabetes mellitus...
October 2015: Journal of the American Association of Nurse Practitioners
(no author information available yet)
No abstract text is available yet for this article.
March 2, 2015: Medical Letter on Drugs and Therapeutics
Heidi Collins Fantasia
Rates of diabetes continue to rise in the United States. It's estimated that more than 25 million people in the United States currently have either type 1 or type 2 diabetes. Insulin is the mainstay of treatment, and a new delivery option is available. In 2014, the U.S. Food and Drug Administration approved Afrezza® inhalation powder, a rapid-acting inhaled form of human insulin, to treat diabetes in adults. This article will provide an overview of the Afrezza system, indications for use, adverse reactions and implications for nurses who work with women with diabetes...
February 2015: Nursing for Women's Health
M Rendell
Technosphere® insulin uses a unique carrier -fumaryl diketopiperazine (FDKP)- which adsorbs insulin to form microparticles to permit delivery to the alveoli by inhalation. Toxicity studies have been entirely negative. The pulmonary absorption of insulin is very rapid, and the disappearance time is shorter than for subcutaneously delivered rapid-acting insulins. As a result, after inhalation, there is a rapid drop in glucose levels which subsequently return to normal in a shorter time than after subcutaneous insulin administration...
December 2014: Drugs of Today
Jahidur Rashid, Shahriar Absar, Kamrun Nahar, Nilesh Gupta, Fakhrul Ahsan
INTRODUCTION: Delivery of therapeutic insulin via the pulmonary route has been the most investigated non-invasive alternative to the commonly used subcutaneous (SC) route for diabetes management. Despite discontinuation of the first inhalable insulin, Exubera®, due to suboptimal market acceptance, development of orally inhaled insulin delivery systems has been galvanized by the recent approval of Afrezza® and several others awaiting approval. AREAS COVERED: The scope of this review article includes the prospects for and the challenges faced in developing inhaled insulin delivery systems; discussion of orally inhaled therapeutic insulin delivery systems that were discontinued, recently approved or are currently under active investigation; and formulation approaches that have the potential to deliver insulin via the pulmonary route...
June 2015: Expert Opinion on Drug Delivery
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