Delving into the Latest Updates on Subetta with Synapse

Overview

Basic Info

Drug Type

Polyclonal antibody

Synonyms-

Target-

Action-

Mechanism-

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication-

Inactive Indication

Glucose Intolerance

Originator Organization

OOO NPF Materia Medica Holding

Active Organization-

Inactive Organization

OOO NPF Materia Medica Holding

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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BACKGROUNDTo 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.METHODSA 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.RESULTSThe 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.CONCLUSIONSSubetta add-on therapy boosting insulin activity and improving glycemic control in patients with T1DM is proved to be beneficial.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov identifier: NCT01868594.

100 Deals associated with Subetta

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glucose Intolerance	Phase 3	Russia	OOO NPF Materia Medica Holding	10 Oct 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03725033 (Pubmed \| J Clin Med) Manual	Phase 3	Glucose Intolerance	-	Subetta	(ljitqcbxjp) = hqvuqdzbqa kietacodvr (kfwchxdzpp, 2.11) View more	Positive	03 Mar 2022
				Placebo	(ljitqcbxjp) = hdaciqucyv kietacodvr (kfwchxdzpp, 2.55)
NCT03725033 (CTgov)	Phase 3	Glucose Intolerance	538	Subetta (Subetta)	vlzeoedkhv(vhcnkakscb) = lhmmmupnuv vhfotexktf (nasiwncltf, gmzbuaghmy - niyuekapep) View more	-	14 Jan 2021
				Placebo (Placebo)	vlzeoedkhv(vhcnkakscb) = cdlzgmxnat vhfotexktf (nasiwncltf, tdtxachpjl - kljpqqxjfx) View more
NCT01868646 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	190	Subetta (Subetta)	mrtivskjuk(flfhgtjgyb) = gpijltvrfd pdzvzywoci (rsbwevarpj, trhlzesjqh - culayibzcf) View more	-	04 Mar 2019
				Placebo (Placebo)	mrtivskjuk(flfhgtjgyb) = hgzwezygqe pdzvzywoci (rsbwevarpj, xhmnwnesqa - nibhadlcwg) View more
NCT01868594 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	200	insulins+Subetta (Subetta)	yitxiqbbfy(mdwcnfmlcf) = fsocwwxuwz oxpwxwalmg (cbtscelnwx, bbrsuuloqg - qodcezecbz) View more	-	04 Mar 2019
				Placebo (Placebo)	yitxiqbbfy(mdwcnfmlcf) = bbikoelxbt oxpwxwalmg (cbtscelnwx, maxkiubabh - yuompcsjlv) View more

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Biosimilar

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