A Phase 2, Single-Dose, Randomized, Open-Label, Active-Controlled, Crossover, Pharmacodynamic, and Pharmacokinetic Comparative Study of a Novel Pramlintide-Insulin Co-Formulation in Adults With Type 1 Diabetes Mellitus

This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).

开始日期2019-08-22

申办/合作机构

Xeris Pharmaceuticals, Inc.

NCT03981627 / Completed临床1/2期

A Randomized, Single-centre, Double-blind, 2-period Cross-over Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.

开始日期2019-06-06

申办/合作机构

Adocia SA

NCT03916640 / Completed临床1期

A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

开始日期2019-01-04

申办/合作机构

Adocia SA

100 项与普兰林肽/胰岛素相关的临床结果

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100 项与普兰林肽/胰岛素相关的转化医学

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100 项与普兰林肽/胰岛素相关的专利（医药）

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项与普兰林肽/胰岛素相关的文献（医药）

2023-05-01·Diabetes, obesity & metabolism

A co‐formulation of pramlintide and insulin A21G (ADO09) improves postprandial glucose and short‐term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes

Article

作者: Gaudier, Martin ; Famulla, Susanne ; Mégret, Claire ; Seroussi, Cyril ; Soula, Olivier ; Eloy, Rosy ; Riddle, Matthew ; Andersen, Grit ; Heise, Tim ; Meiffren, Grégory ; Chan, You‐Ping

Abstract:

Aim:

Pramlintide improves postprandial glucose but requires additional injections. We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co‐formulation, in type 1 diabetes (T1D).

Materials and Methods:

This double‐blinded, randomized, two‐period cross‐over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low‐dose group (LD), n = 28] or 40‐75 U [high‐dose group (HD), n = 16]. Glycaemic responses through continuous glucose monitoring, and pharmacokinetics/pharmacodynamics profiles following mixed‐meal‐tolerance tests were evaluated at baseline and at the end of treatment.

Results:

Glucose increments from 0 to 4 h after mixed‐meal‐tolerance test (primary endpoint) were 39% (not statistically significantly) lower with ADO09 in the low‐dose group and 69% lower in the high‐dose group. Mean continuous glucose monitoring glucose during ambulatory treatment was lower with ADO09 than with aspart (LD: –8.2 ± 7.9 mg/dl, p = .0001; HD: –7.0 ± 10 mg/ml, p = .0127), and time‐in‐range (70–180 mg/dl) improved (LD: +4%, p = .0134; HD: +4%, p = .0432). Body weight declined significantly with ADO09 (LD: –0.8 kg; HD: –1.6 kg). Hypoglycaemic events were slightly more frequent with ADO09 versus aspart (LD: 142 vs. 115; HD: 96 vs. 79). Gastrointestinal events occurred more frequently with ADO09 but were generally transient, and no other safety signals were identified.

Conclusions:

In comparison with aspart, ADO09 was well tolerated and effective in T1D across a wide range of dosage, significantly improving the average blood glucose level and body weight during 24 days of ambulatory treatment. Meal test profiles confirmed improvement of glycaemic patterns and other responses with ADO09.

2021-04-01·Diabetes, obesity & metabolism2区 · 医学

ADO09, a co‐formulation of the amylin analogue pramlintide and the insulin analogue A21G, lowers postprandial blood glucose versus insulin lispro in type 1 diabetes

2区 · 医学

Article

作者: Eloy, Rosy ; Ranson, Aymeric ; Famulla, Susanne ; Seroussi, Cyril ; Chan, You‐Ping ; DeVries, J. Hans ; Gaudier, Martin ; Andersen, Grit ; Soula, Olivier ; Heise, Tim ; Charvet, Richard ; Meiffren, Grégory

Abstract:

Aim:

To compare the safety, pharmacokinetics and pharmacodynamics of ADO09 with insulin lispro (Lispro) and separate subcutaneous injections of human insulin and pramlintide (Ins&Pram) in 24 subjects with type 1 diabetes.

Methods:

At three dosing visits, participants received single doses of ADO09, Ins&Pram or Lispro immediately before eating a standardized mixed meal together with 1 g of acetaminophen, which was used as a surrogate marker to evaluate the kinetics of gastric emptying. Premeal blood glucose was adjusted to 126 mg/dL ± 10% by means of insulin and glucose infusions. The insulin dose was 7.5 U and the pramlintide dose was 45 μg. Blood glucose, glucagon and acetaminophen concentrations were assessed as pharmacodynamic endpoints; insulin and pramlintide concentrations were analysed as pharmacokinetic endpoints, and safety and tolerability were assessed.

Results:

Compared with Lispro, ADO09 reduced postprandial blood glucose (ppBG) excursions by more than 95% in the first hour postmeal (mean ± SD ∆AUC BG 0‐1 h: 1.4 ± 9.9 mg*h/dL vs. 43.5 ± 15.3 mg*h/dL; p < .0001). Maximum ppBG was significantly improved with ADO09 (∆BGmax 87.0 ± 35.5 mg/dL) versus both Lispro (109.2 ± 31.1 mg/dL; p = .0133) and Ins&Pram (109.4 ± 44.3 mg/dL; p = .0357). Gastric emptying with ADO09 was similar to Ins&Pram and significantly slower than with Lispro. All treatments were well tolerated and both adverse events and hypoglycaemic events were rare during the meal test procedure.

Conclusion:

ADO09 was well tolerated and markedly reduced ppBG compared with Lispro. ADO09 formulation was generally similar to the separate administration of insulin and pramlintide, except for a better BG level in the 4‐8 h interval postmeal. These positive results warrant further investigations with ADO09.

项与普兰林肽/胰岛素相关的新闻（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

细胞疗法

100 项与普兰林肽/胰岛素相关的药物交易

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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2期	德国	Adocia SA	2019-06-06

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ADO09 (ADA2021)	N/A	1型糖尿病	16	ADO09	顧鑰淵簾願醖齋餘遞鹽(夢築鏇繭憲鏇壓網選餘) = more adverse events (AEs) occurred with ADO09 (22 vs. 10), most AEs were mild and of gastro-intestinal nature (nausea, decreased appetite) 遞糧簾願襯願膚齋範糧 (遞鬱壓鹹蓋淵鹹鹽鑰醖 ) 更多	积极	2021-06-01
ADO09 (ADA2021)	N/A	1型糖尿病	16	Insulin aspart		积极	2021-06-01
ADO09 (ADA2020)	N/A	1型糖尿病	21	ADO09	製選遞鏇繭鬱醖繭糧糧(壓觸夢選網憲夢鏇衊遞) = more gastrointestinal adverse events (24 vs. 6) observed with ADO09, consistent with typical effect of PRAM 鹽壓齋壓遞願簾鏇憲鑰 (簾遞繭觸憲鬱鬱鏇衊憲 )	积极	2020-06-01