Delving into the Latest Updates on Insulin lispro/Insulin glargine(Adocia SA) with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

BC Combo, BC Combo THDB 0207, BioChaperone Combo

+ [3]

Target

AMYR x INSR

Mechanism

AMYR agonists(Amylin receptor agonists), INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Inactive Indication-

Originator Organization

Adocia SA

Active Organization

Tonghua Dongbao Pharmaceutical Co., Ltd.

Adocia SA

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 4851

The sequence is quoted from: *****

Sequence Code 4857

The sequence is quoted from: *****

Sequence Code 31946

The sequence is quoted from: *****

Sequence Code 31960

The sequence is quoted from: *****

This is a randomised, double-blind, three-period crossover euglycaemic clamp trial comparing pharmacokinetics and pharmacodynamics of BC Combo THDB0207 and Lantus® and Humalog® in subjects with type 1 diabetes.
Each subject will be randomly allocated to one of the 6 treatment sequences and will be administered single subcutaneous doses of BC Combo THDB0207, Lantus®, and Humalog® at three separate dosing visits.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 24-hour clamp procedures have been terminated. Patients will return to the clinical trial centre for outpatient blood sampling visits for analysis of BC449 excipient until 144 hours after each dosing.

Start Date12 May 2022

Sponsor / Collaborator

Adocia SA

[+1]

NCT05373186 / CompletedPhase 1

A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers

This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers.
Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Start Date12 May 2022

Sponsor / Collaborator

Adocia SA

[+1]

NCT05373212 / CompletedPhase 1

A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes

This is a randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects with type 2 diabetes.
Each subject will be randomly allocated to one of four treatment sequences. Each sequence will comprise 3 different single doses of BC Combo THDB0207 (Low dose, Medium dose, and High dose) and one single dose of Humalog® Mix25.
Subjects will come to the clinical trial centre in a fasted state in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Start Date12 May 2022

Sponsor / Collaborator

Adocia SA

[+1]

100 Clinical Results associated with Insulin lispro/Insulin glargine(Adocia SA)

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100 Translational Medicine associated with Insulin lispro/Insulin glargine(Adocia SA)

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100 Patents (Medical) associated with Insulin lispro/Insulin glargine(Adocia SA)

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24

Literatures (Medical) associated with Insulin lispro/Insulin glargine(Adocia SA)

01 Jul 2019·Diabetes, Obesity and MetabolismQ2 · MEDICINE

Better glycaemic control with BioChaperone glargine lispro co‐formulation than with insulin lispro Mix25 or separate glargine and lispro administrations after a test meal in people with type 2 diabetes

Q2 · MEDICINE

Article

Author: Plum‐Mörschel, Leona ; Klein, Oliver ; Anastassiadis, Ernestos ; Meiffren, Grégory ; Mégret, Claire ; Herbrand, Theresa ; DeVries, J. Hans ; Alluis, Bertrand ; Heise, Tim ; Gaudier, Martin ; Soula, Olivier

Because of its physico‐chemical properties, insulin glargine is usually not mixable with rapid insulins. BioChaperone BC147 is a polyanionic amphiphilic polymer, solubilizing insulin glargine at neutral pH, and thus enabling stable glargine formulation with fast‐acting insulin lispro (BioChaperone glargine lispro co‐formulation [BC Combo]). We investigated pharmacokinetic (PK) endpoints and postprandial glucose (PPG) control after administration of BC Combo (75% insulin glargine, 25% insulin lispro), insulin lispro Mix25 (LMix) and separate injections of insulins glargine (75% total dose) and lispro (25% total dose [G + L]) immediately before ingestion of a mixed meal in people with type 2 diabetes mellitus (T2DM), using a randomized, double‐blind, double‐dummy crossover study design. Participants received individualized bolus doses (mean 0.62 U/kg) of BC Combo, LMix or G + L, together with a solid mixed meal (610 kcal, 50% carbohydrate, 30% fat, 20% protein). Insulin dosages were kept constant for each study day. Thirty‐nine participants with T2DM (mean ± SD age and glycated haemoglobin 60.8 ± 7.5 years and 64 ± 6 mmol/mol, respectively) were randomized. BC Combo improved the predefined primary endpoint, early PPG control, compared to LMix (incremental area under the blood glucose concentration–time curve from 0 to 2 hours after the meal [ΔAUCBG,0–2h] reduction of 18%; P = 0.0009) and G + L (ΔAUCBG,0–2h reduction of 10%; P = 0.0450). The number of mealtime hypoglycaemic episodes per participant was lower with BC Combo (22 episodes in 14 participants) compared to LMix (43 episodes in 20 participants; P = 0.0028), but not significantly different from G + L (28 episodes in 19 participants; P = 0.2523). BC Combo demonstrated superior early PPG control with fewer hypoglycaemic episodes compared to LMix and superior early PPG control compared to separate G + L administrations.

01 Jun 2019·Genomics, Proteomics & BioinformaticsQ1 · BIOLOGY

Diversified Application of Barcoded PLATO (PLATO-BC) Platform for Identification of Protein Interactions

Q1 · BIOLOGY

ArticleOA

Author: Qi, Jun ; Que, Jianwen ; Zhu, Jian ; Fiches, Guillaume ; Liu, Shuai ; Hayashi, Tsuyoshi ; Elledge, Stephen J ; Xu, Qikai ; Kong, Weili ; Li, Mamie Z ; Santoso, Netty ; Zhang, Wei

AbstractProteins usually associate with other molecules physically to execute their functions. Identifying these interactions is important for the functional analysis of proteins. Previously, we reported the parallel analysis of translated ORFs (PLATO) to couple ribosome display of full-length ORFs with affinity enrichment of mRNA/protein/ribosome complexes for the “bait” molecules, followed by the deep sequencing analysis of mRNA. However, the sample processing, from extraction of precipitated mRNA to generation of DNA libraries, includes numerous steps, which is tedious and may cause the loss of materials. Barcoded PLATO (PLATO-BC), an improved platform was further developed to test its application for protein interaction discovery. In this report, we tested the antisera-antigen interaction using serum samples from patients with inclusion body myositis (IBM). Tripartite motif containing 21 (TRIM21) was identified as a potentially new IBM autoantigen. We also expanded the application of PLATO-BC to identify protein interactions for JQ1, single ubiquitin peptide, and NS5 protein of Zika virus. From PLATO-BC analyses, we identified new protein interactions for these “bait” molecules. We demonstrate that Ewing sarcoma breakpoint region 1 (EWSR1) binds to JQ1 and their interactions may interrupt the EWSR1 association with acetylated histone H4. RIO kinase 3 (RIOK3), a newly identified ubiquitin-binding protein, is preferentially associated with K63-ubiquitin chain. We also find that Zika NS5 protein interacts with two previously unreported host proteins, par-3 family cell polarity regulator (PARD3) and chromosome 19 open reading frame 53 (C19orf53), whose attenuated expression benefits the replication of Zika virus. These results further demonstrate that PLATO-BC is capable of identifying novel protein interactions for various types of “bait” molecules.

01 Dec 2018·BMC Endocrine DisordersQ4 · MEDICINE

Hyperglycemia-related central pontine demyelinization after a binge-eating attack in a patient with type-2 diabetes: a case report

Q4 · MEDICINE

ArticleOA

Author: Noll, Arno ; Ibe, Richard ; Schreiber, Alexandra ; Girndt, Matthias ; Ackmann, Charlotte ; Katz, Alexandra ; Pliquett, Rainer U

BACKGROUNDHere, we report a case of central pontine demyelinization in a type-2 diabetes patient with hyperglycemia after a binge-eating attack in the absence of a relevant hyponatremia.CASE PRESENTATIONA 55-year-old, male type-2 diabetic patient with liver cirrhosis stage Child-Pugh B was admitted due to dysmetria of his right arm, gait disturbance, dizziness, vertigo, and polyuria, polydipsia after a binge-eating attack of sweets (a whole fruit cake and 2 Liters of soft drinks). A recently initiated insulin therapy had been discontinued for 8 months. A serum glucose measurement obtained 5 days prior to hospitalisation was 38.5 mmol/l (694 mg/dl). The patient graved for sweets since stopping alcohol consumption 8 months earlier. On admission, venous-blood glucose was 29.1 mmol/l (523.8 mg/dl), glycated hemoglobin was 168.0 mmol/mol or 17.6%. No supplementation of sodium chloride was reported. Laboratory exams revealed an elevated serum ammonia level (127.1 μmol/l), rendering a hepatic encephalopathy very likely. After initiation of insulin therapy, capillary glucose normalized, and serum sodium rose from 133 on admission to 144 mmol/l during the hospital stay. In retrospect, the mild hyponatremia on admission was classified as pseudohyponatremia due to hyperglycemia. The patient had an insulin resistance (HOMA-IR 7.8 (normal range < 2.5)). A T2-weighted magnetic resonance imaging (MRI) of the head and a cranial computed tomography scan were obtained demonstrating a symmetric central pontine demyelinization. After 26 days in hospital, the patient was discharged with an inkretin-mimetic therapy (dulaglutide SC, 1.5 mg/week) and an intensified conventional insulin therapy (insulin aspart: 14 units/d in euglycemia, insulin glargin 20 units/d).CONCLUSIONSCentral pontine and/or cerebellar myelinolysis can be caused by sudden, severe, and sustained hyperglycemia, especially when another risk factor (in this case, liver cirrhosis) is present. Functional neurological deficits in the context of hyperglycemia should prompt for the consideration of this differential diagnosis in all diabetes patients.

100 Deals associated with Insulin lispro/Insulin glargine(Adocia SA)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	-	Adocia SA	-
Diabetes Mellitus, Type 1	Preclinical	DE	Adocia SA	14 Mar 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2023	Not Applicable	Diabetes Mellitus, Type 2	1,317	iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) (Insulin naïve)	(uqowddnywy) = amyfqfdrjr yqzunqbnmg (npcbpbhsmh ) View more	-	20 Jun 2023
				Insulin treated	(uqowddnywy) = owhsrhevfc yqzunqbnmg (npcbpbhsmh ) View more
ADA2021	Not Applicable	Diabetes Mellitus, Type 2	442	Fixed ratio combination of insulin glargine 100 U/ml and lixisenatide (iGlarLixi)	(vnzhqphnbe) = rkgfnydqnr fzabgamqjd (yrszzsfahw ) View more	Positive	01 Jun 2021
NCT02915250 (EASD2018)	Phase 1	Diabetes Mellitus, Type 2	-	BioChaperone Combo	mmqekjlsmh(iwsehkwwqo) = numerically fewer subjects experiencing symptomatic hypoglycaemia compared to both Lispro Mix 25 and separate injections of glargine and lispro zplatazxja (kjxanzeyxg )	Positive	02 Oct 2018
				Glargine and Lispro
NCT02514850 (not available, EASD2016)	Phase 1	Diabetes Mellitus, Type 2	24	BioChaperone Combo	jeqnzedumi(fzijitrmpe) = ukvusuazqc lqxwipjgsn (opjyafhrro, 227) View more	Positive	13 Sep 2016
				Lispro	jeqnzedumi(fzijitrmpe) = cedcmxbycx lqxwipjgsn (opjyafhrro, 184) View more
NCT02514954 (EASD2016)	Phase 1	Diabetes Mellitus, Type 1	-	BC Combo	dtfwnpjivp(kzhsakwufr) = sbabzlwjjf ospsejpmgl (vipjmokvdg, (-31 - 166)) View more	Positive	13 Sep 2016
				Lispro Mix 75/25 (LMx)	dtfwnpjivp(kzhsakwufr) = aksljwmuex ospsejpmgl (vipjmokvdg, (20 - 194))
EDICT (Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus Add-on	-	Metformin/pioglitazone/exenatide	(hsbuyvclst) = oiytvkfrns uamiowdkzc (fawaivrjuc )	Positive	01 Mar 2015
				Metformin/sulfonylurea/glargine insulin	(hsbuyvclst) = uyhashrmqy uamiowdkzc (fawaivrjuc ) View more