Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled,...
Mkrtumyan A., Romantsova T. I., Vorobiev S., Volkova A., Vorokhobina N., Tarasov S., Putilovskiy M., Andrianova E., Epstein O.
Diabetes Research and Clinical Practice
Vol.142, P. 1-9
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.1016/j.diabres.2018.04.044
Аннотация:
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
Ключевые слова:
Add-on therapy; Basal-bolus insulin regime; Released-activity; Subetta; Type 1 diabetes mellitus
antidiabetic agent; glucose; hemoglobin A1c; insulin; placebo; subetta; unclassified drug; antibody; antidiabetic agent; subetta; add on therapy; adult; Article; body mass; body weight; controlled study; diet restriction; double blind procedure; drug efficacy; drug safety; female; follow up; glucose blood level; glycemic control; human; hypoglycemia; insulin dependent diabetes mellitus; intention to treat analysis; major clinical study; male; multicenter study; randomized controlled trial; self monitoring; clinical trial; pathology; Adult; Antibodies; Diabetes Mellitus, Type 1; Double-Blind Method; Female; Humans; Hypoglycemic Agents; Male
Язык текста: Английский
ISSN: 1872-8227
Mkrtumyan A.
Romantsova T. I. Tat`yana Ivanovna 1959-
Vorobiev S.
Volkova A.
Vorokhobina N.
Tarasov S.
Putilovskiy M.
Andrianova E.
Epstein O.
Мкртюмян А.
Романцова Т. И. Татьяна Ивановна 1959-
Воробиев С.
Волкова А.
Ворохобина Н.
Тарасов С.
Путиловскиy М.
Андрианова Е.
Епстеин О.
Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial
Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled,...
Текст визуальный непосредственный
Diabetes Research and Clinical Practice
Elsevier Science Publisher B.V.
Vol.142 P. 1-9
2018
Статья
Add-on therapy Basal-bolus insulin regime Released-activity Subetta Type 1 diabetes mellitus
antidiabetic agent glucose hemoglobin A1c insulin placebo subetta unclassified drug antibody antidiabetic agent subetta add on therapy adult Article body mass body weight controlled study diet restriction double blind procedure drug efficacy drug safety female follow up glucose blood level glycemic control human hypoglycemia insulin dependent diabetes mellitus intention to treat analysis major clinical study male multicenter study randomized controlled trial self monitoring clinical trial pathology Adult Antibodies Diabetes Mellitus, Type 1 Double-Blind Method Female Humans Hypoglycemic Agents Male
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