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Inhaled Insulin: A Clinical and Historical Review.

Published on Jan 1, 2017in Cardiology in Review1.552
· DOI :10.1097/CRD.0000000000000143
Jason Chan1
Estimated H-index: 1
(Yeshiva University),
Angela Cheng-Lai10
Estimated H-index: 10
Abstract
Insulin is the most effective blood glucose lowering agent and remains one of the cornerstones of diabetes management. However, many individuals with diabetes are either reluctant to initiate or are nonadherent to their insulin therapy for various reasons, including fear of frequent injections. Technosphere Insulin (TI) is a novel inhaled insulin powder that is approved by the United States Food and Drug Administration for the management of diabetes. The results from 2 phase III clinical trials have shown that TI was noninferior to subcutaneous insulin aspart and superior to inhaled placebo in lowering HbA1c in patients with diabetes mellitus types 1 and 2, respectively. Across both studies, TI appears to be generally well tolerated, with the most common adverse events being hypoglycemia and cough. However, long-term pulmonary safety concerns have not been addressed and additional studies are needed. Overall, TI appears to be a promising noninvasive prandial insulin alternative for individuals with diabetes who are at risk for medication nonadherence due to aversion to frequent injections. This article provides a review of the historical development of TI, its safety and efficacy data, and its advantages and disadvantages over traditional injectable insulins.
  • References (27)
  • Citations (5)
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References27
Newest
#1Tracy L. Setji (Duke University)H-Index: 10
#2Beatrice D. Hong (Duke University)H-Index: 2
Last. Mark N. Feinglos (Duke University)H-Index: 46
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Introduction: Insulin therapy is a mainstay for treatment of diabetes mellitus; however, many barriers to insulin exist. Insulin human inhalation powder (technosphere insulin) is a new FDA-approved alternative to subcutaneous bolus insulin.Areas covered: This is an overview of technosphere insulin (TI). Pharmacokinetics, clinical efficacy, safety and tolerability are discussed.Expert Opinion: TI is more quickly absorbed than subcutaneous insulin therapies and has a shorter duration of action. It...
8 CitationsSource
#1Rima B ShahH-Index: 1
#2Manhar Patel (UIC: University of Illinois at Chicago)H-Index: 1
Last. Viral N. Shah (University of Colorado Denver)H-Index: 20
view all 4 authors...
Many patients with advanced type 2 diabetes mellitus (T2DM) and all patients with T1DM require insulin to keep blood glucose levels in the target range. The most common route of insulin administration is subcutaneous insulin injections. There are many ways to deliver insulin subcutaneously such as vials and syringes, insulin pens, and insulin pumps. Though subcutaneous insulin delivery is the standard route of insulin administration, it is associated with injection pain, needle phobia, lipodystr...
44 CitationsSource
#1Bruce W. BodeH-Index: 49
#2Janet B. McGill (WashU: Washington University in St. Louis)H-Index: 56
Last. David B. Bregman (Albert Einstein College of Medicine)H-Index: 22
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OBJECTIVE To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS This open-label noninferiority trial compared the change in HbA 1c 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 HbA 1c 7.5–10.0% (56.8–86.0 mmol/mol). RESULTS Mean change in HbA 1c in TI patients (–0.21% [–2.3 mmol/mol]) from baseli...
24 CitationsSource
#1Julio RosenstockH-Index: 113
#2Denise FrancoH-Index: 1
Last. Janet B. McGill (WashU: Washington University in St. Louis)H-Index: 56
view all 8 authors...
OBJECTIVE To investigate the efficacy and safety of prandial Technosphere inhaled insulin (TI), an inhaled insulin with a distinct time action profile, in insulin-naive type 2 diabetes (T2D) inadequately controlled on oral antidiabetes agents (OADs). RESEARCH DESIGN AND METHODS 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) ( ...
11 CitationsSource
#1Jack L. Leahy (UVM: University of Vermont)H-Index: 23
Pulmonary-delivered insulin is again a reality (1). The failure of the first inhaled insulin in 2007 showed that being radically different from what health care providers are used to, even when injections are avoided, can be problematic. The current product Technosphere inhaled insulin has addressed many of the prior concerns—a more convenient delivery device that is dosed in insulin units. Also, fear of lung toxicity or tumor development has been lessened somewhat by in vitro cytotoxic (2) and ...
3 CitationsSource
Insulin pumps are a major advance in diabetes management, making insulin dosing easier and more accurate and providing great flexibility, safety, and efficacy for people who need basal-bolus insulin therapy. They are the preferred treatment for people with type 1 diabetes and many with type 2 diabetes who require insulin. This article reviews the basics of how insulin pumps work, who benefits from a pump, and how to manage inpatients and outpatients on insulin pumps.
4 CitationsSource
#1Giuseppe Derosa (UNIPV: University of Pavia)H-Index: 43
#2Pamela Maffioli (UNIPV: University of Pavia)H-Index: 31
1 CitationsSource
#1Esther S. Kim (Springer Science+Business Media)H-Index: 9
#2Greg L. Plosker (Springer Science+Business Media)H-Index: 7
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 di...
13 CitationsSource
#1Grace A. Ledet (XULA: Xavier University of Louisiana)H-Index: 6
#2Richard A. Graves (XULA: Xavier University of Louisiana)H-Index: 13
Last. Tarun K. Mandal (XULA: Xavier University of Louisiana)H-Index: 20
view all 4 authors...
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 wi...
7 CitationsSource
#1Howard Zisser (UCSB: University of California, Santa Barbara)H-Index: 38
#2Eyal Dassau (UCSB: University of California, Santa Barbara)H-Index: 33
Last. Francis J. Doyle (UCSB: University of California, Santa Barbara)H-Index: 67
view all 6 authors...
Objective: The purpose of this study was to investigate whether or not adding a fixed preprandial dose of inhaled insulin to a fully automated closed loop artificial pancreas would improve the postprandial glucose control without adding an increased risk of hypoglycemia. Research Design and Methods: Nine subjects with T1DM were recruited for the study. The patients were on closed-loop control for 24 hours starting around 4:30 pm. Mixed meals (~50 g CHO) were given at 6:30 pm and 7:00 am the foll...
19 CitationsSource
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Abstract We previously reported that insulin-entrapped chitosan complexed carboxymethylated iota-carrageenan (CS/CMCi) particles exhibit pH-responsive swelling behavior. However, the particles’ stability in the enzymatic gastrointestinal environment, their drug permeability mechanism, and related in vivo studies have not been discussed to date. In this study, we investigated the stability, muco-adhesiveness, transport mechanism and in vivo assessment of the particles. The particles retained thei...
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AbstractThe pulmonary delivery of locked nucleic acid containing antisense oligonucleotides (LNA-ASOs) is expected to be a novel therapeutic approach for lung diseases. However, there are two conce...
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ABSTRACTIntroduction: Therapeutic proteins have become a highly attractive drug of choice due to minimal toxicity, high activity and exquisite specificity. Oral delivery of protein drugs is a very interesting area for research, and, naturally, numerous technologies are required to improve the oral bioavailability of therapeutic proteins.Areas covered: This review article systemically generalized the major physiological barriers facing oral macromolecule delivery as well as the current approaches...
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Antibody therapeutics are now established as a major drug class. Here, Carter and Lazar comprehensively discuss current and emerging platforms and technologies for antibody therapeutics, with an emphasis on approaches that could extend their therapeutic applications, including antibody–drug conjugates, bispecific antibodies and antibody engineering to enable more effective delivery.
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