PROMAXX<sup>®</sup> inhaled insulin: safe and efficacious administration with a commercially available dry powder inhaler

Heise, Tim; Brugger, Andrew; Cook, Chyung S.; Eckers, U.; Hutchcraft, Audrey; Nosek, Leszek; Rave, Klaus; Troeger, J.; Valaitis, Paul W.; White, S J; Heinemann, Lutz

doi:10.1111/j.1463-1326.2008.00961.x

Cited by 21 publications

(5 citation statements)

References 4 publications

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“…13,14 Both automated clamps (by means of the Biostator) [1][2][3][4][5][6][7][8][9][10][11][12] and manual clamps have been used for insulin PK/PD assessments. The metabolic effect of the investigated insulin is characterized by the glucose infusion rate (GIR) needed to keep BG constant at a predefined target BG concentration during a euglycemic glucose clamp.…”

Section: Original Articlementioning

confidence: 99%

“…Clinical glucose clamp trials have frequently been used for the evaluation of the pharmacokinetic/pharmacodynamic (PK/PD) properties of different kinds of insulin formulations 1-12 or for the determination of insulin sensitivity. 13,14 Both automated clamps (by means of the Biostator) 1-12 and manual clamps have been used for insulin PK/PD assessments. The metabolic effect of the investigated insulin is characterized by the glucose infusion rate (GIR) needed to keep BG constant at a predefined target BG concentration during a euglycemic glucose clamp.…”

mentioning

confidence: 99%

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How to Assess the Quality of Glucose Clamps? Evaluation of Clamps Performed With ClampArt, a Novel Automated Clamp Device

Benesch

Heise

Klein

et al. 2015

J Diabetes Sci Technol

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Background: There are no widely accepted parameters to assess the quality of glucose clamps. Thus, we selected different parameters describing clamp quality. These parameters were then evaluated in glucose clamps carried out with ClampArt, a novel CE-marked, state-of-the-art fully automated glucose clamp device employing continuous blood glucose (BG) measurements and minute-by-minute adaptations of glucose infusion rate (GIR).Methods: Thirty-nine glucose clamps were performed in 10 healthy and 29 subjects with type 1 diabetes (T1DM) (total duration 583 h). ClampArt-based BG measurements were compared with those obtained with a laboratory reference method. Clamp quality was assessed by 5 parameters: (1) difference (mg/dl) of all paired BG measurements of ClampArt versus reference method ("trueness"), (2) coefficient of variation (CV, %) of ClampArt's BG measurements at target clamp level ("precision"), (3) mean absolute relative difference (MARD, %) at target clamp level ("accuracy"), (4) difference (mg/dl) between ClampArt and target BG ("control deviation"), and (5) percentage operational time ("utility"). Results:ClampArt-based BG measurements showed a trueness of 1.2 ± 2.5 mg/dl. CV and MARD at target BG were 5.5 ± 2.1% and 5.3 ± 2.3%, respectively. There were only small deviations from target level (1.2 ± 1.6 mg/dl). Operational time was as high as 95.4% ± 4.1% (means ± SD). Conclusions:The selected parameters seem to be adequate to characterize clamp quality. The novel, fully automated clamp device ClampArt achieves high clamp quality, which in future trials should be compared with other (automated and manual) clamp methods.

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Section: Original Articlementioning

confidence: 99%

mentioning

confidence: 99%

How to Assess the Quality of Glucose Clamps? Evaluation of Clamps Performed With ClampArt, a Novel Automated Clamp Device

Benesch

Heise

Klein

et al. 2015

J Diabetes Sci Technol

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“…Success for examples such as inhaled administration of human growth hormone [4,5,6] and insulin [7,8,9,10,11,12,13] is a strong motivator for exploring this route of drug administration. Inhaled drug delivery can be the answer to increase bioavailability of poorly soluble drugs that have poor absorption and bioavailability in the gastrointestinal tract when orally administered or are highly metabolized by the liver.…”

Section: Lung Physiologymentioning

confidence: 99%

Targeting Inhaled Therapy beyond the Lungs

Mortensen

Hickey

2014

Respiration

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Pulmonary disease has been the primary target of inhaled therapeutics for over 50 years. During that period, increasing interest has arisen in the use of this route of administration to gain access to the systemic circulation for the treatment of a number of diseases beyond the airways. In order to effectively employ this route, the barriers to transport from the lungs following deposition of aerosols must be considered, including the nature of the disease (whether proximal, as in pulmonary hypertension, or distal, as in diabetes). Delivery to the systemic circulation begins with the efficiency of aerosol generation and subsequent deposition in the airways and proceeds to the influence of mechanisms of clearance, including absorption, metabolism, and mucociliary and cell-mediated transport, on the residence time of the drugs in the lungs. The nature of the drug (small or large molecules/low or high molecular weight), susceptibility to degradation and general physicochemical properties play a role in the chemistry of its formulation, physics of aerosol delivery and biology of disposition.

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“…It is a water based delivery technology for proteins, peptides etc. [246,247] Different devices meant for inhaled delivery of insulin are shown in Figure 5.…”

Section: Exuberamentioning

confidence: 99%

Novel noninvasive techniques in management of diabetes

Sameer¹

2014

Asian J Pharm

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S ince the discovery, insulin remains as effective means of curing the diabetes. During the last decades, diabetes has become a life-threatening disease, because of this people initially goes for insulin injections but the inconvenience leads to the development of noninvasive techniques, which has recently replaced the insulin injection. These techniques overcome the barrier for the insulin treatment and ultimately control the glucose level of patient effectively than invasive technique. In these review, an attempt has been made to cover overall techniques available for diabetes treatment noninvasively. In an attempt of this, data has been collected, which includes insulin delivery via oral, nasal, pulmonary, rectal, buccal and ocular route. Along with these devices available in the market and under trials for diabetes treatment has also been covered. As this disease requires continuous treatment, it is advisable to go with noninvasive means of insulin delivery.

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PROMAXX^® inhaled insulin: safe and efficacious administration with a commercially available dry powder inhaler

Cited by 21 publications

References 4 publications

How to Assess the Quality of Glucose Clamps? Evaluation of Clamps Performed With ClampArt, a Novel Automated Clamp Device

How to Assess the Quality of Glucose Clamps? Evaluation of Clamps Performed With ClampArt, a Novel Automated Clamp Device

Targeting Inhaled Therapy beyond the Lungs

Novel noninvasive techniques in management of diabetes

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PROMAXX® inhaled insulin: safe and efficacious administration with a commercially available dry powder inhaler

Cited by 21 publications

References 4 publications

How to Assess the Quality of Glucose Clamps? Evaluation of Clamps Performed With ClampArt, a Novel Automated Clamp Device

How to Assess the Quality of Glucose Clamps? Evaluation of Clamps Performed With ClampArt, a Novel Automated Clamp Device

Targeting Inhaled Therapy beyond the Lungs

Novel noninvasive techniques in management of diabetes

Contact Info

Product

Resources

About

PROMAXX^® inhaled insulin: safe and efficacious administration with a commercially available dry powder inhaler