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P17

Poster
Protocol of A Randomized, Single blind, placebo -controlled RESCAP, intervention study to determine the safety of RESCAP  in Diabetes: RAPID protocol-Rational and design.

V. Popov1, R. Brands2, N. Bulanova1 (1Moscow RU; 2Wageningen NL)


Type 2 diabetes (T2DM) affects 5.3% of world population with huge impact on healthcare cost, morbidity and mortality. Low grade chronic systemic inflammation results in complications like retinopathy, ESRD, diabetic wounds and adverse pregnancy conditions. Alkaline Phosphatase (AP) supplementation restores diabetes insulin and blood-lipid chemistry in preclinical models. A human field study in T2DM patients reports that AP in feces is reduced 50 %.

We propose oral AP supplementation in T2DM patients. AMRIF, leveraging on the RESCAP® platform, develops therapies for TDM and other chronic inflammatory diseases.  The RESCAP in Diabetes (RAPID) study is an exploratory interventional, multicenter, blinded, randomized controlled trial that is designed to determine safety of RESCAP in T2DM patients with high HbA1C, partially responsive to standard care treatment on metformin. The safety of bRESCAP has been extensively investigated. bRESCAP safety and efficacy is established in a variety of preclinical disease models and in  a clinical trials,  either i.v. or s.c. formulations. To date, APPIRED-III study with RESCAP is in phase 3 of development in cardiothoracic surgery patients. In topical/oral settings, safety & efficacy was established in patients with IBD.  RAPID may yield long term safety data (primary outcome) and health benefits in T2DM. Secondary outcome parameter changes: e.g. HbA1C, bloodlipid chemistry, low-grade systemic inflammation, adverse events, general well-being. Duration: 9 months (the Clinical phase). Upon ethical approval, RAPID is conducted under ICH  GCP .

    
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            [titel] => Protocol of A Randomized, Single blind, placebo -controlled RESCAP, intervention study to determine the safety of RESCAP  in Diabetes: RAPID protocol-Rational and design.

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Type 2 diabetes (T2DM) affects 5.3% of world population with huge impact on healthcare cost, morbidity and mortality. Low grade chronic systemic inflammation results in complications like retinopathy, ESRD, diabetic wounds and adverse pregnancy conditions. Alkaline Phosphatase (AP) supplementation restores diabetes insulin and blood-lipid chemistry in preclinical models. A human field study in T2DM patients reports that AP in feces is reduced 50 %.

We propose oral AP supplementation in T2DM patients. AMRIF, leveraging on the RESCAP® platform, develops therapies for TDM and other chronic inflammatory diseases.  The RESCAP in Diabetes (RAPID) study is an exploratory interventional, multicenter, blinded, randomized controlled trial that is designed to determine safety of RESCAP in T2DM patients with high HbA1C, partially responsive to standard care treatment on metformin. The safety of bRESCAP has been extensively investigated. bRESCAP safety and efficacy is established in a variety of preclinical disease models and in  a clinical trials,  either i.v. or s.c. formulations. To date, APPIRED-III study with RESCAP is in phase 3 of development in cardiothoracic surgery patients. In topical/oral settings, safety & efficacy was established in patients with IBD.  RAPID may yield long term safety data (primary outcome) and health benefits in T2DM. Secondary outcome parameter changes: e.g. HbA1C, bloodlipid chemistry, low-grade systemic inflammation, adverse events, general well-being. Duration: 9 months (the Clinical phase). Upon ethical approval, RAPID is conducted under ICH  GCP .

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Vladimir POPOV
RU-135215 Moscow
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