Ashot Mkrtumyan1, Tatyana Romantsova2, Sergei Vorobiev3, Anna Volkova4, Natalia Vorokhobina5, Sergey Tarasov6, Mikhail Putilovskiy7, Elena Andrianova8, Oleg Epstein9. 1. Moscow Clinical Scientific and Practical Center named after A.S. Loginov, 86, Enthusiastov Sh., 111123 Moscow, Russian Federation. Electronic address: vagrashot@mail.ru. 2. Sechenov First Moscow State Medical University, 8-2, Trubetskaya St., 119991 Moscow, Russian Federation. Electronic address: romantsovatatiana@rambler.ru. 3. Rostov State Medical University, 29, Nakhichevan Per., 344022 Rostov-on-Don, Russian Federation. Electronic address: endocrinrostov@mail.ru. 4. Pavlov First Saint Petersburg State Medical University, 6-8, Lva Tolstogo St., 197022 Saint Petersburg, Russian Federation. Electronic address: volkovaa@mail.ru. 5. Elizavetinskaya Municipal Hospital, 14, Vavilovyh St., 195257 Saint Petersburg, Russian Federation. Electronic address: endocrinology@inbox.ru. 6. OOO "NPF "MATERIA MEDICA HOLDING", 9, 3rd Samotyochny Per., 127473 Moscow, Russian Federation. Electronic address: tarasovsa@materiamedica.ru. 7. OOO "NPF "MATERIA MEDICA HOLDING", 9, 3rd Samotyochny Per., 127473 Moscow, Russian Federation. Electronic address: putilovskiyma@materiamedica.ru. 8. OOO "NPF "MATERIA MEDICA HOLDING", 9, 3rd Samotyochny Per., 127473 Moscow, Russian Federation. Electronic address: AndrianovaEN@materiamedica.ru. 9. The Institute of General Pathology and Pathophysiology, 8, Baltiyskaya St., 125315 Moscow, Russian Federation. Electronic address: epstein@mail.ru.
Abstract
BACKGROUND: To examine efficacy of Subetta as an add-on to insulin therapy in patients with type 1 diabetes mellitus (T1DM) 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 was previously proved to activate insulin signaling pathway. METHODS: A total of 144 randomized patients with poor glycemic control in basal-bolus insulin regime were included in intention-to-treat analysis in Subetta add-on therapy or placebo (n = 72 in both groups). Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), basal and prandial insulin doses, number of hypoglycemia episodes confirmed by self-monitoring of blood glucose were recorded for 36 weeks. RESULTS: The baseline characteristics of subjects did not differ between the two groups. HbA1c mean (±standard deviation) change was -0.59 ± 0.99% (95% CI -0.84 to -0.37) after 36 weeks in Subetta (vs. -0.20 ± 1.14%; 95% CI -0.44 to 0.11 in placebo; p = 0.028). The rate of overall hypoglycemia events was 7.9 per patient year (95% CI 7.1-8.6) in Subetta group and 7.6 (95% CI 6.9-8.4) in Placebo group (p = 0.63). The basal and total insulin doses did not change at the end of 36 weeks in both groups. CONCLUSIONS:Subetta add-on therapy boosting insulin activity and improving glycemic control in patients with T1DM is proved to be beneficial. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01868594.
RCT Entities:
BACKGROUND: To examine efficacy of Subetta as an add-on to insulin therapy in patients with type 1 diabetes mellitus (T1DM) 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 was previously proved to activate insulin signaling pathway. METHODS: A total of 144 randomized patients with poor glycemic control in basal-bolus insulin regime were included in intention-to-treat analysis in Subetta add-on therapy or placebo (n = 72 in both groups). Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), basal and prandial insulin doses, number of hypoglycemia episodes confirmed by self-monitoring of blood glucose were recorded for 36 weeks. RESULTS: The baseline characteristics of subjects did not differ between the two groups. HbA1c mean (±standard deviation) change was -0.59 ± 0.99% (95% CI -0.84 to -0.37) after 36 weeks in Subetta (vs. -0.20 ± 1.14%; 95% CI -0.44 to 0.11 in placebo; p = 0.028). The rate of overall hypoglycemia events was 7.9 per patient year (95% CI 7.1-8.6) in Subetta group and 7.6 (95% CI 6.9-8.4) in Placebo group (p = 0.63). The basal and total insulin doses did not change at the end of 36 weeks in both groups. CONCLUSIONS: Subetta add-on therapy boosting insulin activity and improving glycemic control in patients with T1DM is proved to be beneficial. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01868594.
Authors: Sergey N Avdeev; Alexander A Vizel; Vladimir N Abrosimov; Andrey A Zaicev; Galina L Ignatova; Rustem F Khamitov; Marina P Mikhaylusova; Julia S Shapovalova; Elena F Pavlysh; Basil I Trofimov; Alexander V Emelyanov; Tatiana I Martynenko; Vladimir A Martynenko; Natalia E Kostina; Danila A Chizhov; Olga Yu Chizhova; Natalia A Kuzubova; Elena V Makova; Ekaterina V Makarova Journal: Int J Chron Obstruct Pulmon Dis Date: 2021-05-05