A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta
Impaired glucose tolerance (IGT) is a common carbohydrate metabolism disorder world-wide. To evaluate the efficacy and safety of 12-week Subetta therapy in correcting 2-h plasma glucose in patients with IGT, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. De...
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| Veröffentlicht in: | Journal of clinical medicine 2022-03, Vol.11 (5), p.1390 |
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| creator | Mkrtumyan, Ashot Ametov, Alexander Demidova, Tatiana Volkova, Anna Dudinskaya, Ekaterina Vertkin, Arkady Vorobiev, Sergei |
| description | Impaired glucose tolerance (IGT) is a common carbohydrate metabolism disorder world-wide. To evaluate the efficacy and safety of 12-week Subetta therapy in correcting 2-h plasma glucose in patients with IGT, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to insulin receptor β-subunit and endothelial NO synthase, Subetta increases the sensitivity of insulin receptors by activating the insulin signaling pathway. Oral glucose tolerance test (OGTT), fasting plasma glucose (FPG), and glycated hemoglobin (HbA1c) were examined at screening, after 4 and 12 weeks. In Per Protocol population, 2-h plasma glucose in the Subetta group decreased by 2.05 ± 2.11 mmol/L (versus 0.56 ± 2.55 mmol/L in the Placebo group) after 12 weeks. The difference between the two groups was 1.49 ± 2.33 mmol/L (p < 0.0001). After 12 weeks, 65.2% of patients had 2-h plasma glucose |
| doi_str_mv | 10.3390/jcm11051390 |
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To evaluate the efficacy and safety of 12-week Subetta therapy in correcting 2-h plasma glucose in patients with IGT, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to insulin receptor β-subunit and endothelial NO synthase, Subetta increases the sensitivity of insulin receptors by activating the insulin signaling pathway. Oral glucose tolerance test (OGTT), fasting plasma glucose (FPG), and glycated hemoglobin (HbA1c) were examined at screening, after 4 and 12 weeks. In Per Protocol population, 2-h plasma glucose in the Subetta group decreased by 2.05 ± 2.11 mmol/L (versus 0.56 ± 2.55 mmol/L in the Placebo group) after 12 weeks. The difference between the two groups was 1.49 ± 2.33 mmol/L (p < 0.0001). After 12 weeks, 65.2% of patients had 2-h plasma glucose <7.8 mmol/L. FPG remained almost unchanged. HbA1c tended to decrease. The number of adverse events did not differ in both groups. Subetta treatment is beneficial for patients with IGT; it also prevents progression of carbohydrate metabolism disorders.</description><identifier>ISSN: 2077-0383</identifier><identifier>EISSN: 2077-0383</identifier><identifier>DOI: 10.3390/jcm11051390</identifier><identifier>PMID: 35268481</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Antibodies ; Body mass index ; Carbohydrates ; Chronic illnesses ; Clinical medicine ; Clinical trials ; Diabetes ; Disease ; Double-blind studies ; Gastrointestinal surgery ; Glucose ; Hypertension ; Insulin resistance ; Laboratories ; Metabolic disorders ; Obesity ; Overweight ; Patients ; Plasma ; Substance abuse treatment ; Weight control</subject><ispartof>Journal of clinical medicine, 2022-03, Vol.11 (5), p.1390</ispartof><rights>2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). 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Subetta treatment is beneficial for patients with IGT; it also prevents progression of carbohydrate metabolism disorders.</description><subject>Antibodies</subject><subject>Body mass index</subject><subject>Carbohydrates</subject><subject>Chronic illnesses</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Disease</subject><subject>Double-blind studies</subject><subject>Gastrointestinal surgery</subject><subject>Glucose</subject><subject>Hypertension</subject><subject>Insulin resistance</subject><subject>Laboratories</subject><subject>Metabolic disorders</subject><subject>Obesity</subject><subject>Overweight</subject><subject>Patients</subject><subject>Plasma</subject><subject>Substance abuse treatment</subject><subject>Weight control</subject><issn>2077-0383</issn><issn>2077-0383</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNpdkk1v1DAQhiMEotXSE3dkiQsSDdixkzgcKi1LKSsVWrXLOfLHhPXKiRfbabX9of09OGqpFnywx-Nn3pmRJ8teE_yB0gZ_3KieEFySZD_LDgtc1zmmnD7fsw-yoxA2OC3OWUHql9kBLYuKM04Os_s5-gG3aL7deifUGkWHLm7AK9cDWg5htGZAVxBMiGJQgNLtUkQDQwzo1sQ1WvZbYTxodGZH5QKglbPgJ_YTWq1hih1tgl2HBPqeTKNSMPhj9MWN0kL-OWXQx-jSCgXS5Qs3RO-sheS7EoN2vblL6otEGSUsWnmT9qR22nXJoXYoQehadBB3k_t6lBCjeJW96IQNcPR4zrKfX09Xi2_5-cXZcjE_zxXDTczrUmnGteBayoZSxnGjtZZloygBRllZgqirSnS64LUkQpBKEilKyUpSKV7RWXbyoLsdZQ966s0L22696YXftU6Y9t-XwazbX-6m5Q3BvC6TwLtHAe9-jxBi25ugwFoxgBtDW1SU1wWe_nGWvf0P3bjRD6m9iaprhhkvEvX-gVLeheCheyqG4HYamXZvZBL9Zr_-J_bvgNA_6IG_pQ</recordid><startdate>20220303</startdate><enddate>20220303</enddate><creator>Mkrtumyan, Ashot</creator><creator>Ametov, Alexander</creator><creator>Demidova, Tatiana</creator><creator>Volkova, Anna</creator><creator>Dudinskaya, Ekaterina</creator><creator>Vertkin, Arkady</creator><creator>Vorobiev, Sergei</creator><general>MDPI AG</general><general>MDPI</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20220303</creationdate><title>A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta</title><author>Mkrtumyan, Ashot ; 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To evaluate the efficacy and safety of 12-week Subetta therapy in correcting 2-h plasma glucose in patients with IGT, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to insulin receptor β-subunit and endothelial NO synthase, Subetta increases the sensitivity of insulin receptors by activating the insulin signaling pathway. Oral glucose tolerance test (OGTT), fasting plasma glucose (FPG), and glycated hemoglobin (HbA1c) were examined at screening, after 4 and 12 weeks. In Per Protocol population, 2-h plasma glucose in the Subetta group decreased by 2.05 ± 2.11 mmol/L (versus 0.56 ± 2.55 mmol/L in the Placebo group) after 12 weeks. The difference between the two groups was 1.49 ± 2.33 mmol/L (p < 0.0001). After 12 weeks, 65.2% of patients had 2-h plasma glucose <7.8 mmol/L. FPG remained almost unchanged. HbA1c tended to decrease. The number of adverse events did not differ in both groups. Subetta treatment is beneficial for patients with IGT; it also prevents progression of carbohydrate metabolism disorders.</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>35268481</pmid><doi>10.3390/jcm11051390</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Antibodies Body mass index Carbohydrates Chronic illnesses Clinical medicine Clinical trials Diabetes Disease Double-blind studies Gastrointestinal surgery Glucose Hypertension Insulin resistance Laboratories Metabolic disorders Obesity Overweight Patients Plasma Substance abuse treatment Weight control |
| title | A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta |
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