A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

开始日期2012-08-01

申办/合作机构

Biodel, Inc.

100 项与 Ultra-rapid-acting insulin analogues(Albireo Pharma, Inc.) 相关的临床结果

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100 项与 Ultra-rapid-acting insulin analogues(Albireo Pharma, Inc.) 相关的专利（医药）

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178

项与 Ultra-rapid-acting insulin analogues(Albireo Pharma, Inc.) 相关的文献（医药）

2024-12-01·Journal of Diabetes and its Complications

Subcutaneous rapid-acting insulin analogues in mild to moderate diabetic ketoacidosis: A meta-analysis of randomized controlled trials

Review

作者: de A. De H. Morais, Beatriz A. ; Francisco, Hugo Valinho ; Parolin, Salma Ali El Chab ; Defante, Maria L R ; Prizão, Vitória M ; De Hollanda Morais, Beatriz A de A ; De Hollanda Morais, Beatriz A. de A. ; Mendes, Beatriz X. ; de Souza, Mariana M. ; Defante, Maria L.R. ; Prizão, Vitória M. ; de Souza, Mariana de Moura ; Mendes, Beatriz Ximenes

INTRODUCTIONDiabetic Ketoacidosis (DKA) is commonly treated with intravenous (IV) regular insulin. However, patients with less severe DKA may benefit from a subcutaneous (SC) scheme.METHODSWe systematically searched PubMed, Cochrane, and Embase for randomized controlled trials (RCTs) comparing SC rapid-acting insulin analogue (RAIAs) with IV regular insulin. Risk ratios (RR) were used to compare treatment effects for binary outcomes and mean differences (MD) for continuous data with the corresponding 95 % confidence intervals (CI). P values <0.05 were considered statistically significant. We used the R version 4.3.2 for statistical analyses.RESULTSOur meta-analysis included eight RCTs encompassing 415 patients. No statistically significant differences were found between RAIAs and IV regular insulin in the treatment of mild to moderate DKA in the pediatric and adult population in the primary outcome of time until DKA resolution (MD 0.00 h; 95 % CI -1.27 to 1.28; P = 1.00). Both treatments showed comparable results in the secondary outcomes total insulin usage (P = 0.65), time until hyperglycemia resolution (P = 0.22), length of hospital stay (P = 0.11), the incidence of hypoglycemia (P = 0.15) and DKA recurrence (P = Not estimable). There were no reports of death, cerebral edema, or venous thrombosis in the studies.CONCLUSIONIn this meta-analysis of eight RCTs we found that SC RAIAs and regular IV insulin are comparable in resolving mild to moderate DKA in children and adults. PROSPERO registration: CRD42023485032.

2024-10-18·Journal of diabetes science and technology

Impact of Ultra-Rapid Insulin on Boost and Ease-Off in the Cambridge Hybrid Closed-Loop System for Individuals With Type 1 Diabetes.

Article

作者: Hartnell, Sara ; Lakshman, Rama ; Bally, Lia ; Boughton, Charlotte ; Mader, Julia K ; Thabit, Hood ; Royston, Chloë ; Wilinska, Malgorzata E ; Nwokolo, Munachiso ; Allen, Janet M ; Hovorka, Roman ; Evans, Mark L ; Leelarathna, Lalantha ; Ware, Julia

OBJECTIVEThe objective was to evaluate the safety and efficacy of ultra-rapid-acting insulin with the Boost and Ease-off features of the Cambridge hybrid closed-loop system.METHODSA secondary analysis of Boost and Ease-off from two double-blind, randomized, crossover hybrid closed-loop studies comparing (1) Fiasp to insulin aspart (n = 25), and (2) Lyumjev to insulin lispro (n = 26) was carried out. Mean glucose on initialization of Boost and Ease-off, change in glucose 60 and 120 minutes after initialization, duration and frequency of use, mean glucose, and time in, above, and below target glucose range were calculated for periods of Boost use, Ease-off use, or neither.RESULTSParticipants used Boost for longer with Fiasp than insulin aspart (median [interquartile range, IQR] = 75 [53-125] minutes vs 60 [49-75] minutes; P = .01). Mean glucose on Boost initialization with Fiasp was 238 ± 62 mg/dL compared with 218 ± 45 mg/dL with insulin aspart (P = .08). Fiasp use resulted in a greater glucose reduction 120 minutes after Boost initialization [-59 ± 34 mg/dL vs -43 ± 31 mg/dL; P = .02]. There were no statistically significant differences in sensor glucose endpoints during Boost or Ease-off periods between Fiasp and aspart. There were no statistically significant differences during Boost or Ease-off periods when comparing Lyumjev with insulin lispro. There were no safety issues when using Boost and Ease-off with ultra-rapid insulins.CONCLUSIONSThe use of Fiasp and Lyumjev during Boost or Ease-off resulted in comparable safety and efficacy to using insulin aspart and lispro.

2024-08-01·Diabetes Technology & Therapeutics

Are New Ultra-Rapid-Acting Insulins Associated with Improved Glycemic Control and Reduced Hypoglycemia in Comparison to Conventional Rapid-Acting Insulins for Individuals with Type 1 and Type 2 Diabetes? A Systematic Review and Meta-Analysis

Review

作者: Galdón Sanz-Pastor, Alba ; Ampudia-Blasco, Francisco Javier ; Villar-Taibo, Rocío ; Barajas Galindo, David ; Fernández-Rubio, Elsa ; Simó Servat, Andreu

Introduction: This study aimed to compare efficacy and safety of ultra-rapid-acting insulin analogs (URAIs; faster aspart [FAsp], ultra-rapid lispro [URLi], and technosphere insulin [TI]) with rapid-acting insulin analogs (RAI) in individuals with type 1 (T1D) or type 2 diabetes (T2D). Methods: Searching for randomized control trial comparing the effects of URAI versus RAI that lasted at least 12 weeks, we initially selected 15 studies for analysis. Three studies involving TI were excluded due to a high degree of heterogeneity. The final meta-analysis included only 12 studies with either FAsp or URLi. Results: Mealtime URAI significantly reduced overall early 1 h postprandial glycemia in individuals with T1D (-20.230 mg/dL [95% confidence interval, 95% CI -24.040 to -16.421]; P < 0.001; I² = 33.42%) and those with T2D (-9.138 mg/dL [95% CI -12.612 to -5.663]; P < 0.001; I² = 0%). However, the significant reduction in 2 h postprandial glucose remained only in individuals with T1D (-17.620 mg/dL [95% CI -26.047 to -9.193]; P < 0.001; I² = 65.88%). These benefits were lost when URAI was administered postmeal. At 24-26 weeks, there was no significant difference in HbA1c between groups, but at 52 weeks, a slight reduction in HbA1c with mealtime URAI was observed (-0.080% [95% CI -0.147 to -0.013]; P = 0.019; I² = 0%). No difference in weight or the rate of severe or confirmed hypoglycemia was observed. Only individuals with T1D showed a small, but significant increase in early 1-h hypoglycemia with URAI (1.468 [95% CI 1.235 to 1.747]; P < 0.001; I² = 0%). Conclusion: Mealtime URAI improves 1 and 2 h postprandial glycemic control compared to RAI without increasing hypoglycemia or weight gain.

项与 Ultra-rapid-acting insulin analogues(Albireo Pharma, Inc.) 相关的新闻（医药）

2021-06-15

·GlobeNewswire

ADOCIA Announces M1Pram Clinical Data Presentation at the

LYON, France, June 15, 2021 (GLOBE NEWSWIRE) -- ADOCIA (Euronext Paris: FR0011184241 – ADOC), a clinical-stage biopharmaceutical company specializing in the development of innovative formulations of proteins and peptides, announced today Adocia will have an oral presentation on the bi-hormonal treatment M1Pram (ADO09) at the 81st Scientific Sessions of the American Diabetes Association which will be held June 25-29, 2021, as a virtual event. Topline results of this positive study were shared in a press release distributed on September 15, 2020. In this oral presentation, Gregory Meiffren, Clinical Development Director at Adocia will present the study and its key results. Adocia is currently studying M1Pram in a Phase 2 study, with results expected in Q2 2022. About the American Diabetes Association Scientific Sessions The American Diabetes Association’s Scientific Sessions offer researchers and health care professionals from around the globe an exclusive opportunity to share ideas and gain knowledge about the recent advances in diabetes research, treatment and care. Attendees will have access to more than 3,000 original research presentations, take part in thought-provoking speaking engagements with leading diabetes experts, and expand their professional networks. About Adocia ADOCIA is a clinical-stage biotechnology company that specializes in the development of innovative formulations of therapeutic proteins and peptides for the treatment of diabetes, obesity and metabolic diseases. In the diabetes field, Adocia’s portfolio of injectable treatments is among the largest and most differentiated of the industry, featuring five clinical-stage products and several pre-clinical products. The proprietary BioChaperone® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone® to each protein for a given application. Adocia’s clinical pipeline includes four novel insulin formulations for prandial treatment of diabetes: two ultra-rapid formulations of insulin analog lispro (BioChaperone® Lispro U100 and U200), a combination of basal insulin glargine and rapid acting insulin lispro (BioChaperone® Combo) and one combination of a prandial insulin with amylin analog pramlintide M1Pram. The clinical pipeline also includes an aqueous formulation of human glucagon (BioChaperone® Glucagon) for the treatment of hypoglycemia. Adocia’s preclinical pipeline for diabetes treatment includes bi-hormonal combinations: two combinations of rapid acting insulin analogs and Pramlintide (BioChaperone® Lispro Pram and BioChaperone® Aspart Pram), and a combination of insulin glargine with GLP-1 receptor agonists (BioChaperone® Glargine Liraglutide). Adocia recently added a cell therapy initiative focused on development of a hydrogel scaffold for use in people with type 1 diabetes. The first patent application supporting this program has been filed. Adocia’s preclinical pipeline for the treatment of obesity includes two bi-hormonal products: a combination of glucagon and exenatide (BioChaperone® Glucagon Exenatide) and a combination of pramlintide and exenatide (PramExe). Contact Adocia Disclaimer

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床1期	-	Albireo Pharma, Inc.	-
1型糖尿病	临床1期	澳大利亚	Biodel, Inc.	-
1型糖尿病	临床1期	澳大利亚	Biodel, Inc.	-
1型糖尿病	临床1期	-	Albireo Pharma, Inc.	-