A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT05663515 / Not yet recruitingNot Applicable

EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs

EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up.

Start Date17 Jun 2024

Sponsor / Collaborator

AstraZeneca PLC

NCT06252623 / RecruitingPhase 1IIT

A Human Laboratory Study of Exenatide for Reducing the Reinforcing Effects of Cocaine

This study will determine the safety and tolerability of exenatide (Bydureon®) as a pharmacotherapy for cocaine use disorder. An inpatient human laboratory study will be conducted in which the self-administration of cocaine, as well as the subjective and physiological effects of cocaine, are evaluated during maintenance on placebo and exenatide.
Although exenatide (Bydureon) is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, it has not been approved by the FDA to treat cocaine use; therefore, it is called an investigational drug.

Start Date01 Jun 2024

Sponsor / Collaborator

Baylor College of Medicine

100 Clinical Results associated with Exenatide

100 Translational Medicine associated with Exenatide

100 Patents (Medical) associated with Exenatide

3,878

Literatures (Medical) associated with Exenatide

31 Dec 2024·Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology

GLP1R boosts survival, migration and invasion of endometrial cancer cells and protects against ferroptotic cell death

Article

Author: Ruan, Fan ; Li, Wu ; Lyu, Wen ; Liu, Songjun ; Zhang, Xinmei

BACKGROUND:

Despite the strong evidence concerning carcinogenic roles of glucagon-like peptide 1 receptor (GLP1R), the role of this gene in endometrial cancer (EC) remains elusive. This study investigated the properties of GLP1R on EC in vitro.

METHODS:

The expression of GLP1R in EC was detected by RT-qPCR, immunohistochemistry, and western blotting. Cell viability, cell cycle, apoptosis, migration, invasion and ferroptosis were assessed through CCK-8, flow cytometry, wound healing, transwell, DCFH-DA and western blotting, respectively.

RESULTS:

We found that GLP1R was up-regulated in EC than normal specimens. It had the highest expression in AN3CA cells. Cell viability, migration and invasion were significantly reduced, while cell cycle arrest and apoptosis were induced following GLP1R knockdown. The malignant biological behaviours of AN3CA cells were investigated when treated with exendin-4 (GLP1R agonist). Moreover, GLP1R lowered intracellular ROS level and expression of SLC7A11, and FTH1, but mitigated GPX4 expression in AN3CA cells.

CONCLUSION:

In a word, GLP1R was up-regulated in EC and its up-regulation facilitated the proliferative and metastatic potentials, and protected cells from ferroptosis, thereby accelerating EC progression. These data emphasised the potency of GLP1R as a therapeutic agent against EC.

01 May 2024·CNS & neurological disorders drug targets

Clinical Benefits of Therapeutic Interventions Targeting Mitochondria in Parkinson’s Disease Patients

Review

Author: Ciocca, Matteo ; Pizzamiglio, Chiara

Abstract::

Parkinson’s disease is the second most common neurodegenerative disease. Mitochondrial dysfunction has been associated with neurodegeneration in Parkinson’s disease, and several treatments targeting mitochondria have been tested in these patients to delay disease progression and tackle disease symptoms. Herein, we review available data from randomised, double-blind clinical studies that have investigated the role of compounds targeting mitochondria in idiopathic Parkinson’s disease patients, with a view of providing patients and clinicians with a comprehensive and practical paper that can inform therapeutic interventions in this group of people. A total of 9 compounds have been tested in randomized clinical trials, but only exenatide has shown some promising neuroprotective and symptomatic effects. However, whether this evidence can be translated into daily clinical practice still needs to be confirmed. In conclusion, targeting mitochondrial dysfunction in Parkinson’s disease is a promising therapeutic approach, although only one compound has shown a positive effect on Parkinson’s disease progression and symptoms. New compounds have been investigated in animal models, and their efficacy needs to be confirmed in humans through robust, randomised, double-blind clinical trials.

01 Apr 2024·Domestic animal endocrinology

Insulin release from isolated cat islets of Langerhans

Article

Author: Ley, Cecilia ; Strage, Emma M ; Westermark, Gunilla T ; Tengholm, Anders

Feline diabetes mellitus is a common endocrine disease with increasing prevalence. It shows similarities with human type 2 diabetes and is characterized by insulin resistance and deficient insulin secretion. Moreover, cats and humans belong to the very few species that form amyloid depositions in the pancreatic islets. However, little is known about cat islet function and no studies have addressed insulin secretion from isolated islets ex vivo. The aim of this study was to establish a protocol for isolation of islets of Langerhans from pancreata of cats euthanized due to disease, and to evaluate insulin secretion responses to various physiological and pharmacological stimuli. Collagenase digestion of pancreatic tissue from 13 non-diabetic cats and two cats with diabetic ketoacidosis yielded individual islets surrounded by a layer of exocrine tissue that was reduced after two days in culture. Histological examination showed islet amyloid in pancreatic biopsies from most non-diabetic and in one diabetic cat. Islets from non-diabetic cats cultured at 5.5 mM glucose responded with increased insulin secretion to 16.7 mM glucose, 30 mM K⁺ and 20 µM of the sulfonylurea glipizide (2-3 times basal secretion at 3 mM glucose). The glucagon-like peptide-1 receptor agonist exendin-4 (100 nM) had no effect under basal conditions but potentiated glucose-triggered insulin release. Only one of nine islet batches from diabetic cats released detectable amounts of insulin, which was enhanced by exendin-4. Culture of islets from non-diabetic cats at 25 mM glucose impaired secretion both in response to glucose and K⁺ depolarization. In conclusion, we describe a procedure for isolation of islets from cat pancreas biopsies and demonstrate that isolated cat islets secrete insulin in response to glucose and antidiabetic drugs. The study provides a basis for future ex vivo studies of islet function relevant to the understanding of the pathophysiology and treatment of feline diabetes.

102

News (Medical) associated with Exenatide

27 Jun 2024

·www.drugs.com

Exercise + GLP-1 RA Effective for Weight Loss While Preserving BMD

THURSDAY, June 27, 2024 -- For adults with obesity, without diabetes, combining exercise with the glucagon-like peptide-1 receptor agonist (GLP-1 RA), liraglutide , is effective for weight loss, while preserving bone health, according to a study published online June 25 in JAMA Network Open . Simon Birk Kjær Jensen, Ph.D., from the University of Copenhagen in Denmark, and colleagues examined bone health at clinically relevant sites after diet-induced weight loss followed by a one-year intervention with exercise, liraglutide, or both in a secondary analysis of a randomized trial involving adults aged 18 to 65 years with obesity, without diabetes. After an eight-week low-calorie diet, participants were randomly allocated to exercise alone, the GLP-1 RA liraglutide alone, the combination, or placebo for 52 weeks (48, 49, 49 and 49 participants, respectively). The researchers found that the total estimated mean change in weight losses during the study was 7.03 kg in the placebo group and 11.19, 13.74, and 16.88 kg in the exercise, liraglutide, and combination groups, respectively. Bone mineral density (BMD) was unchanged in the combination group versus the placebo group at the hip and lumbar spine. BMD decreased for the liraglutide versus the exercise group at the hip and spine (mean changes, −0.013 and −0.016 g/cm 2 , respectively). "Our findings highlight the importance of combining exercise with GLP-1 RA treatment for bone health," the authors write. Novo Nordisk supplied the liraglutide and placebo pens; Cambridge Weight Plan supplied low-calorie meal replacement products. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

26 Jun 2024

·www.echemi.com

Novo Nordisk's Semaglutide - A Breakthrough in Obesity Management

Semaglutide, the active ingredient in Novo Nordisk's Wegovy®, is a GLP-1 receptor agonist that works by binding to and activating the GLP-1 receptor, thereby exerting its effects in the treatment of obesity. Given that the GLP-1 receptor is involved in the specific brain regions that regulate appetite, the application of Wegovy® in obese patients can significantly reduce hunger, enhance satiety, and decrease food cravings, thereby assisting patients in reducing caloric intake and achieving weight loss. Moreover, through genetic engineering, Wegovy® has been successful in extending its half-life to 7 days, allowing for a once-weekly dosing regimen, providing Chinese patients with a safe and convenient weight management solution. Zhangkezhou, the Corporate Vice President of Pharmaceutical Quality at Novo Nordisk Greater China, stated that Novo Nordisk's research in the field of obesity treatment has spanned over 25 years, and the company has established a solid scientific foundation based on GLP-1RA therapy. The company is committed to comprehensively addressing the overall health of obese patients and aims to provide them with an integrated treatment plan. Looking ahead, Novo Nordisk will continue to lead the innovative breakthroughs in the field of obesity treatment to meet the diverse medical needs of Chinese patients. Zhou Xiaping, the Global Senior Vice President and President of Novo Nordisk Greater China, emphasizes that as a global leader in the field of obesity treatment, Novo Nordisk is dedicated to changing the world's perception, prevention, and treatment of obesity. Coinciding with Novo Nordisk China's 30th anniversary, Wegovy® as the company's latest innovative drug introduced to China will effectively address the unmet medical needs in the field of obesity treatment in China. The company is grateful for the support and guidance from the National Medical Products Administration and relevant government departments in accelerating the introduction of innovative drugs to China, as well as the contributions of researchers and participants in the clinical trials. Novo Nordisk will uphold its mission of "driving change and working together to overcome serious chronic diseases" and focus on patient-centricity, accelerating innovation, and diversifying and comprehensively contributing to the prevention and treatment of chronic diseases in China, supporting the "Healthy China 2030" initiative. It is hereby declared that the approved Wegovy® (for long-term weight management in adults) and the already marketed Ozempic® (for the treatment of type 2 diabetes in adults) are both prescription drugs, targeting different diseases and cannot be substituted for each other. About Wegovy® (semaglutide injection for long-term weight management) Wegovy® is the world's first and currently the only once-weekly GLP-1RA for long-term weight management, providing not only significant weight loss but also multiple health benefits. Wegovy® has been launched in over 10 countries and regions globally. Wegovy® is indicated for long-term weight management in adults with an initial body mass index (BMI) of: - BMI ≥ 30 kg/m² (obesity) - BMI 27 kg/m² to < 30 kg/m² (overweight) with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Wegovy® can achieve an average weight loss of 17% (16.8 kg) and provide multiple health benefits, including reduced waist circumference, decreased visceral fat, improved lipid profile, and delayed progression to type 2 diabetes. In the global STEP clinical trial series covering over 25,000 overweight and obese participants, as well as real-world data studies, Wegovy® has demonstrated good safety and tolerability. Its active ingredient, semaglutide, has up to 94% structural homology with human GLP-1 and has been extensively validated for its safety, used by 5.4 million patients globally. The most common adverse reactions of Wegovy® are mild to moderate transient gastrointestinal events. About the STEP Clinical Trial Series The STEP clinical trial series for Wegovy® (semaglutide injection for long-term weight management) started in June 2018 and has completed 14 trials to date, including 12 global Phase 3 trials, 1 regional Phase 3 trial in East Asia, and 1 regional Phase 3 trial primarily in China. These trials have study durations of 11-24 months, with an average maximum treatment period of 34 months, aiming to evaluate the efficacy, safety, and other health benefits of Wegovy® in the long-term weight management of adults. Overall, the STEP clinical trial data have shown that Wegovy® can significantly reduce the weight of adult overweight and obese patients across different regions, ethnicities, ages, and genders, with or without type 2 diabetes, with an average weight loss of 17% (16.8 kg), and has demonstrated good safety and tolerability.

Phase 3Drug ApprovalClinical Result

25 Jun 2024

·www.biospace.com

Endogenex™ Announces $88 Million Series C Financing to Complete Pivotal Trial of the ReCET™ System in Patients with Type 2 Diabetes

Oversubscribed financing led by strategic investor, with participation from new and existing investors MINNEAPOLIS, June 25, 2024 /PRNewswire/ -- Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes, announced it has closed an oversubscribed Series C financing totaling $88 million. The new capital will be used to complete the pivotal ReCET Clinical Study, which has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA). A group of new investors, including Hatteras Venture Partners, Lumira Ventures, and Orlando Health Ventures, joined an undisclosed strategic lead investor and existing investors Intuitive Ventures, Longitude Capital, Mayo Clinic, and Santé Ventures in the Series C funding. "We are excited to take this significant step forward in our mission to transform diabetes care," said Stacey Pugh, CEO of Endogenex. "This funding will enable us to complete our pivotal clinical study, bringing us closer to offering a groundbreaking solution for type 2 diabetes patients. The therapeutic landscape in diabetes continues to evolve, especially around the earlier use of SGLT2i and GLP-1RA. However, there remains a considerable unmet need to address the underlying pathophysiology and progression of the disease." "We are very proud of the company's progress, and this successful funding round is a testament to Endogenex's innovative technology," said Juliet Tammenoms Bakker, Endogenex Board Chair and Managing Director at Longitude Capital. "This milestone underscores our investors' confidence in the company's vision and the impact it can make in treating the epidemic of type 2 diabetes around the world." About the ReCET Clinical Study The ReCET Clinical Study is a multicenter, prospective, randomized, double-blinded, sham-controlled study assessing the safety and effectiveness of the ReCET System. The pivotal study received IDE approval in November 2023. The study will enroll up to 350 patients at clinical sites in the United States and Australia. About the ReCET™ Procedure ReCET is a novel, endoscopic outpatient procedure that targets the cellular pathology of the duodenum. This pathology may contribute to the development and progression of type 2 diabetes. The ReCET System aims to initiate the body's natural regenerative process by applying highly controlled, non-thermal pulsed electric fields to the mucosa and sub-mucosa duodenal tissue. This approach may help restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels. The ReCET System has been evaluated in feasibility clinical studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. These studies assessed the safety and efficacy of the treatment in adults with type 2 diabetes whose blood glucose levels were inadequately controlled despite using insulin and non-insulin medications. Preliminary outcomes from these studies have been presented at medical conferences globally. The ReCET System has received an FDA Breakthrough Device Designation for treating type 2 diabetes in adults inadequately controlled by glucose-lowering medications. About Endogenex™ Endogenex, founded in partnership with Mayo Clinic, aims to revolutionize treatment options for individuals with type 2 diabetes (T2D). The company's innovations focus on resetting the body's metabolic signaling system by harnessing its natural regenerative capabilities to improve metabolic function. Through the development of the ReCET System and the novel application of precise, controlled, non-thermal pulsed electric fields, Endogenex is establishing a new era in T2D therapy, helping patients regain control of their blood glucose levels and slow disease progression. For more information, please visit . Media Inquiries: Brent Collins bcollins@endogenex.com +1(612) 227-6949

Clinical Study

100 Deals associated with Exenatide

External Link

KEGG	Wiki	ATC	Drug Bank
D04121	Exenatide	A10BJ01	DB01276

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	AstraZeneca AB	28 Apr 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	NL	AstraZeneca PLC	21 Feb 2017
Hypoglycemia	Phase 3	NL	AstraZeneca PLC	21 Feb 2017
Polycystic Ovary Syndrome	Phase 3	US	AstraZeneca PLC	22 Mar 2016
Hyperglycemia	Phase 3	FR	Eli Lilly & Co.	01 Jan 2015
Hyperglycemia	Phase 3	FR	AstraZeneca PLC	01 Jan 2015
Coronary Artery Disease	Phase 3	CZ	Eli Lilly & Co.	01 Jun 2011
Ventricular Dysfunction, Left	Phase 3	CZ	Eli Lilly & Co.	01 Jun 2011
Obesity	Phase 3	US	National Institute of Diabetes & Digestive & Kidney Diseases	03 Mar 2009
Myocardial Infarction	Phase 2	CA	AstraZeneca PLC	01 Feb 2014
Hypothalamic obesity	Phase 2	US	Amylin Pharmaceuticals, Inc.	01 Jan 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03029351 (CTgov)	Phase 4	Kidney Diseases \| Diabetes Mellitus, Type 2 \| Proteinuria	15	Exenatide Extended Release for Inj Susp 2 MG (Exenatide Extended Release)	byrvygqadg(erahstxged) = beitdzxasy xsbwziypqh (mbvgkwbuug, bnjymvhblk - jsyjeecmvm) View more	-	16 Apr 2024
				Placebo (Placebo)	byrvygqadg(erahstxged) = ecyjleconl xsbwziypqh (mbvgkwbuug, kpspwlqvhn - abfwmwohwu) View more
NCT02962492 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	70	Placebo (Placebo Arm:)	jekhfkgxps(ibkufhqjnu) = eneivbwbnl nzsoazferm (ipzrlmazci, jjlzngredt - cucteixket) View more	-	29 Feb 2024
				Dapagliflozin (Dapagliflozin Arm:)	jekhfkgxps(ibkufhqjnu) = anokdqkjdi nzsoazferm (ipzrlmazci, fqxwfnijgg - myiqrcpjgu) View more
NCT01524705 (FLAT-SUGAR, CTgov)	Phase 4	Diabetes Mellitus, Type 2	102	Insulin Glargine+Exenatide+Metformin	kgoxbsswbh(olevkrpqvx) = xswzbkudeg dmobheeaqt (nqjdsgtpcq, cejjqxofok - kgbxjenwyu) View more	-	29 Dec 2023
NCT02621489 (Rebuild study, EASD2023)	Phase 4	Diabetes Mellitus, Type 2 HbA1c	38	Exenatide	inkupmnpyg(tokptpgose) = hwkhpajaka idncnvoftd (oputxshjwb ) View more	Negative	04 Oct 2023
				Standard treatment	inkupmnpyg(tokptpgose) = hugimtmaai idncnvoftd (oputxshjwb ) View more
Rebuild study (ESC2023)	Not Applicable	Diabetes Mellitus, Noninsulin-Dependent, 2	38	Bydureon	ysepdftaii(izojqlskuv) = tnyutzbtuz dsujpqhrbb (vrwwhgvhqw ) View more	-	25 Aug 2023
				Standard treatment	ysepdftaii(izojqlskuv) = vhqbzwvtrz dsujpqhrbb (vrwwhgvhqw ) View more
NCT03331289 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	107	Placebo (Placebo)	ygdwlldwup(iadqsiqulg) = onewhtoeml rnutieppdh (bzhpeutovs, tqdaxajlbg - dpzjkhytnz) View more	-	24 Jul 2023
				Exenatide (Exenatide)	ygdwlldwup(iadqsiqulg) = fuuwwjitjc rnutieppdh (bzhpeutovs, beehslifqr - skmkglujau) View more
NCT02981069 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	90	Dapagliflozin (Dapagliflozin)	jgvwgljcxg(qjkjznmzaf) = yvxucptepz rftsbhflwl (rmfocyicpt, rvrnvxirlo - oxevzxerrx) View more	-	20 Jul 2023
				Placebo (Placebo)	jgvwgljcxg(qjkjznmzaf) = vrjphqmldr rftsbhflwl (rmfocyicpt, ljgnjmrdmd - wkklyuckhz) View more
NCT02251431 (CTgov)	Phase 3	Functional disorder \| Diabetes Mellitus, Type 2 \| Cardio-Renal Syndrome ... View more	57	BYDUREON (Exenatide-extended Release)	qfpdwltbpu(adxbgirtrs) = dmaseppzce kmzkalxscw (qpmhgfyzxc, ctdvytwehi - derdplbuzm) View more	-	17 May 2023
				Placebo (Placebo)	qfpdwltbpu(adxbgirtrs) = svurybmlzd kmzkalxscw (qpmhgfyzxc, znyznytpng - xparmausvc) View more
NCT01154933 (CTgov)	Phase 2	Inflammation \| Type 2 diabetes mellitus in obese	24	exenatide 10 mcg (Exenatide 10 mcg)	jdnmbdsvuy(sguzycwkur) = rxfnmmmdkh qgkqchoqik (ifshqcrxwu, kkxtqxurkc - peirylrjut) View more	-	06 Oct 2022
				placebo (Placebo)	jdnmbdsvuy(sguzycwkur) = khnrdvyman qgkqchoqik (ifshqcrxwu, rcycgepsad - tcqrgwnmqg) View more
EASD2022	Not Applicable	Fractures, Bone	-	GLP-1RA	hpewzkyclk(lqnfaaibxz): HR = 0.89 (95% CI, 0.76 - 1.05)	Positive	22 Sep 2022
				DPP-4i

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis