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).

Start Date22 Aug 2019

Sponsor / Collaborator

Xeris Pharmaceuticals, Inc.

NCT03981627 / CompletedPhase 1/2

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.

Start Date06 Jun 2019

Sponsor / Collaborator

Adocia SA

NCT03916640 / CompletedPhase 1

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.

Start Date04 Jan 2019

Sponsor / Collaborator

Adocia SA

100 Clinical Results associated with Pramlintide/Insulin(Adocia)

100 Translational Medicine associated with Pramlintide/Insulin(Adocia)

100 Patents (Medical) associated with Pramlintide/Insulin(Adocia)

Literatures (Medical) associated with Pramlintide/Insulin(Adocia)

01 Oct 2024·Diabetes, Obesity and Metabolism

ADO09, a co‐formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes

Article

Author: DeVries, J. Hans ; Heise, Tim ; Seroussi, Cyril ; Chan, You‐Ping ; Soula, Olivier ; Riddle, Matthew ; Andersen, Grit ; Mégret, Claire ; Eloy, Rosy ; Gaudier, Martin

AbstractAimTo study safety, efficacy and weight loss with ADO09, a co‐formulation of insulin A21G and pramlintide, in type 1 diabetes.Materials and MethodsA randomized, two‐arm ambulatory 16‐week study compared ADO09 with insulin lispro in 80 participants with type 1 diabetes. We compared changes of weight, glycated haemoglobin, glycaemic patterns during continuous glucose monitoring, and insulin doses at baseline and at the end of treatment.ResultsA significant and continuing weight loss, the primary endpoint, was observed with ADO09 compared with lispro as prandial insulin. In the whole group, the weight loss with ADO09 relative to lispro was 2.1 kg. Glycaemic control was relatively good (7.7% mean glycated haemoglobin) in both groups and did not change during treatment. Prandial insulin doses were reduced by 21% in the ADO09 group, whereas basal insulin dosage was not modified. Gastrointestinal symptoms were more frequent with ADO09, but no clear difference in hypoglycaemia was observed.ConclusionsThese results extend previous observations on the efficacy and safety of this insulin/pramlintide co‐formulation. They show a beneficial effect on weight, using less mealtime insulin and without increased hypoglycaemia.

01 May 2023·Diabetes, Obesity and 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

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

AbstractAimPramlintide 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 MethodsThis 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.ResultsGlucose 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.ConclusionsIn 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.

01 Apr 2021·Diabetes, Obesity and MetabolismQ2 · MEDICINE

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

Q2 · MEDICINE

Article

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

AbstractAimTo 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.MethodsAt 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.ResultsCompared 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.ConclusionADO09 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.

News (Medical) associated with Pramlintide/Insulin(Adocia)

15 Jun 2021

·www.globenewswire.com

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

Cell Therapy

100 Deals associated with Pramlintide/Insulin(Adocia)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 2	-	Adocia SA	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Not Applicable	Diabetes Mellitus, Type 1	-	ADO09	(bczldziuol) = pghmzgidkn pqnowlcspn (qydokmvanj ) View more	-	12 Jan 2023
				Insulin aspart	(bczldziuol) = hbbrujmqnd pqnowlcspn (qydokmvanj ) View more
ADO09 (ADA2021)	Not Applicable	Diabetes Mellitus, Type 1	16	ADO09	qxhmbwtwru(bpghjqazhp) = more adverse events (AEs) occurred with ADO09 (22 vs. 10), most AEs were mild and of gastro-intestinal nature (nausea, decreased appetite) lbileljruv (acjzgzrvkv ) View more	Positive	01 Jun 2021
				Insulin aspart
ADO09 (ADA2020)	Not Applicable	Diabetes Mellitus, Type 1	21	ADO09	osntnrapoz(mmkgxwbmru) = more gastrointestinal adverse events (24 vs. 6) observed with ADO09, consistent with typical effect of PRAM yrbxkmmvex (kxayzpsrci )	Positive	01 Jun 2020
ADO09 (EASD2019)	Not Applicable	Diabetes Mellitus, Type 1	24	ADO09	(zibwbyxqcf) = 3 with ADO09, 2 with Ins&Pram hzepknsuny (kgudazikpx ) View more	Positive	18 Sep 2019
				Insulin lispro

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