Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of the SynerG TM CGM sensor Integrated with the Niia Essential Insulin Patch Pump System in Persons with Type 1 Diabetes.

Start Date24 Mar 2025

Sponsor / Collaborator-

NL-OMON57171

/ SuspendedNot Applicable

Phoenix: Clinical evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult subjects with Type 1 Diabetes - Phoenix

Start Date06 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with NNC0268-0965

100 Translational Medicine associated with NNC0268-0965

100 Patents (Medical) associated with NNC0268-0965

122,204

Literatures (Medical) associated with NNC0268-0965

31 Dec 2025·ANNALS OF MEDICINE

Bioengineering and omics approaches for Type 1 diabetes practical research: advancements and constraints

Review

Author: Li, Ling ; An, Zhenmei ; Peng, Yihua ; Peng, Xi ; Zhou, Guangju

Insulin dependency arises from autoimmunity that targets the β cells of the pancreas, resulting in Type 1 diabetes (T1D). Despite the fact that T1D patients require insulin for survival, insulin does not provide a cure for this disease or prevent its complications. Despite extensive genetic, molecular, and cellular research on T1D over the years, the translation of this understanding into effective clinical therapies continues to pose a significant obstacle. It is therefore difficult to develop effective clinical treatment strategies without a thorough understanding of disease pathophysiology. Pancreatic tissue bioengineering models of human T1D offer a valuable approach to examining and controlling islet function while tackling various facets of the condition. And in recent years, due to advances in high-throughput omics analysis, the genotypic and molecular profiles of T1D have become finer tuned. The present article will examine recent progress in these areas, along with their utilization and constraints in the realm of T1D.

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Emergency medicine pharmacists’ interventions in the tertiary hospitals’ emergency departments in Malaysia

Article

Author: Teh, Lih Jiuan ; Tan, Shirlyn ; Tan, Sherene Su Ann ; Bhuvanendran Pillai, Anaanthan ; Sia, Rosalind Guen Lin ; Guee, Xin Nee ; Selvaratanam, Manimegahlai ; Koh, Hock Peng ; Koo, Yee Ping ; Wong, Wai Kit ; Chen, Mary Siew Yng ; Ab Jalal, Haliza

Background:

The emergency medicine (EM) pharmacist is an integrated part of the Emergency Department (ED) interdisciplinary team in many countries, including Malaysia. The presence of EM pharmacists in the ED has positively impacted patient outcomes. Data on EM pharmacists' interventions is scarce in the Asian region. In Malaysia, data on interventions done by EM pharmacists in the EDs was unavailable. This study aimed to assess the type of interventions done by EM pharmacists in the ED of tertiary public hospitals in Malaysia.

Methods:

This cross-sectional, multicenter study involved EM pharmacists from 14 tertiary hospitals in Malaysia. All accepted interventions done by EM pharmacists in the ED for patients admitted to the Red (critical) and Yellow (semi-critical) zones from January to June 2022 were extracted from the Clinical Pharmacy Report Form. All data were analyzed descriptively.

Results:

The EM pharmacists documented 1659 accepted interventions on 1584 patients during the study period. Inappropriate regimens (n = 1117, 67.3%) and incomplete prescriptions (n = 339, 20.4%) were the main categories of accepted interventions in ED. Inappropriate drug (n = 574, 34.6%), dose (n = 292, 17.6%), and frequency (n = 176, 10.6%) were the top three subcategory interventions documented under inappropriate regimens. Antimicrobials, antihypertensives, and proton pump inhibitors were the commonest drug intervened under the categories of inappropriate drug intervention. There were 272 (16.4%) accepted interventions on high-alert medications (HAMs). Insulin, enoxaparin, and noradrenaline were the most intervened HAMs.

Conclusion:

Inappropriate treatment regimens were the most common intervention category done by EM pharmacists in Malaysia. The significant number of interventions done by EM pharmacists demonstrated the importance of EM pharmacists as integral members of the EM team. This data can help improve the quality of clinical pharmacy services in the ED and is important for the future expansion of clinical pharmacy services in all EDs across Malaysia, neighbouring countries, and other developing countries.

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Effect of statins and antihyperglycemics on chronic kidney disease in patients with type 2 diabetes mellitus: a retrospective cohort study with a 12-year follow-up

Article

Author: El-Dahiyat, Faris ; Mohammed, Khuloud Jamal ; Al Jaberi, Asma Khaled ; Shahwan, Moyad ; Jairoun, Ammar Abdulrahman ; Al Jawamis, Dina Farhan ; Ping, Chong Chee ; Dawoud, Tasnim ; Ibrahim, Baharudin

Background:

Chronic Kidney Disease (CKD) represents a significant worldwide health challenge, with far-reaching implications for both patients and healthcare systems. This study aimed to identify the incidence of CKD at stages 3-5, analyzed the impact of statin and other antihyperglycemic interventions, on the CKD progression in individuals with T2DM.

Methods:

This was a single-center retrospective cohort study based on data derived from electronic medical records (EMR) of UAE populations with diabetes mellitus, registered at outpatient clinics at Tawam Hospital in Al Ain, UAE, between January 2011 and December 2021. T2DM patients aged ≥ 18 years who had serum HbA1c level ≥ 6.5% and using one of the statin therapies were inclusion criteria. Patients with T1DM, who had undergone permanent renal replacement therapy, with under 1 year of follow-up and missing or incomplete data were excluded from the study. The collected data encompassed socio-demographics, detailed medical history, anthropometric measurements, laboratory analyses, clinical parameters, disease characteristics, and medications.

Results:

Our study included a cohort of 1,003 individuals. We observed 388 subjects developed CKD stages 3-5 across an average monitoring duration of 11.7 years. This resulted in a cumulative incidence of 38.7%, translating to an incidence rate of 38 cases per 1000 person-years. There was a statistically significant difference in the cumulative incidence of CKD stages 3 ± 5 according to statin therapy (P = 0.047). High intensity statin users are more likely to develop a CKD stage 3-5 compared to low/moderate intensity users and to no statin users respectively (44.3% vs 37.9%), (44.3% vs 30.9%). Conversely, the use of Biguanides was associated with a decreased probability of CKD progression (37.9% vs. 52.8%; P = 0.001), whereas Insulin users demonstrated a heightened risk (54.2% vs. 34.1%; P < 0.001).

Conclusion:

The findings emphasise the pivotal role of personalised treatment strategies, particularly concerning statin therapy and other medications, in populations at high risk.

809

News (Medical) associated with NNC0268-0965

26 Jun 2025

·www.prnewswire.com

BioCity's ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria

Second BTD Recognition Highlights Compound's Potential as Next-Generation Broad-Spectrum Renal Therapy SHANGHAI, June 25, 2025 /PRNewswire/ -- BioCity Biopharma ("BioCity") announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its highly selective endothelin receptor type A (ETA) antagonist SC0062 for the treatment of diabetic kidney disease (DKD) with albuminuria. This marks the second BTD for SC0062, following its initial designation for IgA nephropathy (IgAN) with proteinuria, which is conducting in Phase III, underscoring the compound's transformative potential across multiple chronic kidney disease (CKD) indications. The designation is supported by compelling data from the DKD cohort of the Phase 2 2-SUCCEED study, where SC0062 demonstrated: 1) Statistically and clinically significant albuminuria reduction at the 20 mg dose versus placebo. 2) Favorable safety profile with no increase in the risk of fluid retention observed in the SC0062 group. 3) Good safety both as monotherapy and in combination with standard-of-care therapies including SGLT2 inhibitors, RAAS inhibitors, GLP-1 receptor agonists, insulin, and Finerenone (MRA).Most participants in the trial received SGLT2 (sodium-glucose co-transporter-2) inhibitors and RAAS (renin-angiotensin-aldosterone system) inhibitors as background therapies, over 70% received GLP-1 (Glucagon-like peptide-1) receptor agonists and/or insulin, and approximately one-third were on Finerenone (a mineralocorticoid receptor antagonist, MRA). "With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges," said Dr. Ivy Wang, BioCity Co-founder and Executive President. "This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide." Clinical and Commercial Context The completed Phase 2 2-SUCCEED program met all efficacy and safety endpoints in both IgAN and DKD cohorts at 12- and 24-week timepoints. Full DKD results will be presented at an upcoming international congress. DKD, affecting ~20.9 million patients in China (2021), drives the nation's CKD epidemic. Without innovation, age-standardized incidence rates（ASIR）are projected to rise 25% by 2036. Current therapies provide limited protection against progression to end-stage renal disease (ESRD). As an ETA antagonist showing optimized effect for CKD, SC0062 represents a mechanistically distinct approach that: Modulates renal hemodynamics Reduces proteinuria/albuminuria Counters inflammation and fibrosis With its demonstrated clinical benefits and superior selectivity profile, SC0062 is positioned to potentially become a best-in-class renal therapeutic. BioCity remains committed to advancing this promising candidate through late-stage development for multiple kidney disease indications. About SC0062 SC0062 is a novel and unique ETA antagonist characterized by its high selectivity for ETA compared to the endothelin receptor B (ETB). Its strong selectivity for ETA suggests that it has greater potential than non-selective endothelin receptor antagonists for slowing the progression of CKD while avoiding the side effects associated with non-selective medications in the same class used to treat IgAN and DKD and other types of CKD. Preclinical studies showed that SC0062 significantly improved pathological scores in acute and chronic kidney disease models. Completed Phase 1 studies demonstrated good safety, tolerability, and pharmacokinetics, with no signs of fluid retention. SC0062 has completed enrollment in both cohorts (IgAN and DKD) of the Phase 2 2-SUCCEED study. The IgAN cohort has met primary and secondary endpoints, with results published in JASN. The DKD cohort has now also met its primary and secondary endpoints. SC0062 has now received BTD twice from the CDE – first for IgAN with proteinuria and now for DKD with albuminuria. BioCity is conducting initiate two Phase 3 trials: SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). SUCCESS-01 has been launched at Guangdong Provincial People's Hospital, led by Professor Xueqing Yu, President of the hospital and President of the Asia-Pacific Society of Nephrology. About BioCity Biopharma Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC). Currently, SC0062 a highly selective ETA antagonist owned by BioCity, is in development for CKD. A Phase 3 confirmatory trial for IgAN has been initiated in China and a Phase 3 multi-regional clinical trial (MRCT) is being planned. In addition, BioCity has five core novel oncology assets in clinical development, including first-in-class CDH3- and GPC3-targeting antibody drug conjugates (ADCs), WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3. For more information, please visit: LinkedIn: BioCity Biopharma Business & Investment Inquiries: [email protected] | [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Breakthrough TherapyPhase 1

24 Jun 2025

·pmlive.com

Eli Lilly shares promising phase 3 results for once-weekly insulin candidate efsitora alfa

Eli Lilly has shared promising phase 3 results for its once-weekly insulin candidate efsitora alfa in adults with type 2 diabetes (T2D). All three studies met their primary endpoint of non-inferior A1C reduction compared to daily basal insulin, according to data presented at this year’s American Diabetes Association Scientific Sessions. More than 4.3 million people in the UK have diabetes, with T2D accounting for around 90% of all cases. Current treatment options focus on disease management and include diet and exercise, diabetes medications and insulin therapy. It is hoped that an insulin option specifically designed for once-weekly subcutaneous administration could improve adherence rates and quality of life for patients with the chronic condition. QWINT-1, which evaluated efsitora alfa in patients using insulin for the first time, showed that Lilly’s candidate reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52. In the trial, efsitora was titrated across four fixed doses at four-week intervals, as needed for blood glucose control. In QWINT-3 and QWINT-4, which enrolled patients who had previously used daily basal insulin, and those who had previously used daily basal insulin and mealtime insulin, respectively, efsitora was given using traditional insulin dosing, with adjustments based on each patient’s glucose level. At week 26 in QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec. At the same time point in QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine. Efsitora also demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for T2D across all three studies. Jeff Emmick, senior vice president of product development at Lilly, said: “These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach.” Lilly said it is planning to submit global regulatory applications for efsitora as a treatment for adults with T2D by the end of this year. “We look forward to working with regulatory agencies to bring this innovation to patients around the world,” Emmick said.

Clinical ResultPhase 3

23 Jun 2025

·www.prnewswire.com

Mifepristone Shown to Reduce A1C in Patients with Difficult-to-Control Type 2 Diabetes and Hypercortisolism

Study Results Signal Paradigm Shift in Diabetes Care for Patients with Difficult-to-Control Type 2 Diabetes CHICAGO, June 23, 2025 /PRNewswire/ -- New findings from the CATALYST study show that the use of mifepristone resulted in improved blood glucose (blood sugar) control and weight reduction in patients with difficult-to-control type 2 diabetes and hypercortisolism. The results of the largest prospective trial of its kind were presented as a late-breaking symposium at the 85th Scientific Sessions of the American Diabetes Association® (ADA) in Chicago, and simultaneously published in Diabetes Care®. Among patients with type 2 diabetes, more than half do not achieve blood glucose targets as assessed by the hemoglobin A1C test, despite substantial lifestyle efforts and multiple medications. The CATALYST study explored whether hypercortisolism is a contributing factor in people with difficulty achieving A1C targets despite multiple medications. Hypercortisolism is a condition where the body produces too much cortisol, which can raise blood glucose. Part 1 of the CATALYST study, presented at the 84th Scientific Sessions, revealed that hypercortisolism may be a significant contributing factor in one in four patients with difficult-to-control diabetes. Patients with hypercortisolism presenting as uncontrolled type 2 diabetes physically appear the same as those without hypercortisolism, but they do seem to require more medications and have more complications. Part 2 of the CATALYST study was a randomized, prospective, placebo-controlled, double-blind multi-center trial designed to assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult-to-control type 2 diabetes. 136 participants with hypercortisolism received either mifepristone or placebo over a 24-week period to assess the impact on glycemic control and other metabolic parameters. Mifepristone is a medication that reduces the effects of cortisol and is FDA approved for the treatment of elevated blood glucose in patients with hypercortisolism and prediabetes or type 2 diabetes. Mifepristone reduced A1C by 1.5% as compared to a reduction of 0.2% with placebo. The A1C reductions occurred even as many patients decreased or stopped other diabetes medications, including insulin. In addition, treatment of hypercortisolism with mifepristone was associated with nearly 10 pounds of weight loss and a reduction in waist circumference of more than two inches. "These findings demonstrate a potentially promising treatment solution for patients with difficult-to-treat type 2 diabetes and hypercortisolism, a patient population frustrated with poor results of their diabetes care," said John Buse, MD, PhD, from the University of North Carolina School of Medicine and one of the authors of the study. "By treating the root cause—excess cortisol—we saw meaningful improvements in both blood glucose and weight which could be game changing when it comes to managing type 2 diabetes." The authors note that results may translate to expanded screening for hypercortisolism in patients with type 2 diabetes. Future research is needed to understand whether patients with less advanced type 2 diabetes may experience similar benefits, if other cortisol-directed therapies offer similar results, and whether long-term treatment will provide benefits in preventing complications associated with inadequately controlled type 2 diabetes. Research presentation details: Dr. Buse will present the findings at the following symposium along with Drs. Ralph DeFronzo, Vanita Aroda, and Vivian Fonseca: Symposium: Treatment of Hypercortisolism in People with Difficult-to-Control Type 2 Diabetes—Final Results of the CATALYST Trial Presented on Monday, June 23 at 3:15 p.m. CT About the ADA's Scientific Sessions The ADA's 85th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held in Chicago, IL on June 20-23. Thousands of leading physicians, scientists, and health care professionals from around the world are expected to convene both in person and virtually to unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Attendees will receive exclusive access to thousands of original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Join the Scientific Sessions conversation on social media using #ADASciSessions. About the American Diabetes Association The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to end diabetes and helping people thrive. This year, the ADA celebrates 85 years of driving discovery and research to prevent, manage, treat, and ultimately cure—and we're not stopping. There are 136 million Americans living with diabetes or prediabetes. Through advocacy, program development, and education, we're fighting for them all. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (800-342-2383). Join us in the fight on Facebook (American Diabetes Association), Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn (American Diabetes Association), and Instagram (@AmDiabetesAssn). To learn more about how we are advocating for everyone affected by diabetes, visit us on X (@AmDiabetesAssn). Media Contact: [email protected] SOURCE American Diabetes Association WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalClinical Study

100 Deals associated with NNC0268-0965

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	Germany	Novo Nordisk A/S	29 Oct 2019
Diabetes Mellitus, Type 1	Phase 1	Germany	Novo Nordisk A/S	05 Jun 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2024	Not Applicable	-	-	U-500 Insulin	ogailoiyeu(tireryzpki) = qgxlanasix xgsyvqpqbx (hcrsiferrh ) View more	-	14 Jun 2024
				U-100 Insulin	ogailoiyeu(tireryzpki) = keboxbdrbv xgsyvqpqbx (hcrsiferrh ) View more
975-P (ADA2024)	Not Applicable	Diabetes Mellitus, Type 1	49	Ultrarapid insulin analogs (FiAsp)Insulclock Connected Insulin Cap (Ultrarapid insulin analogs (FiAsp))	racmxkefvo(yctrcugicq) = iwlejzsmvy kbpmqndgsg (fpyykukbdr ) View more	-	14 Jun 2024
				Rapid insulin analogs	racmxkefvo(yctrcugicq) = dvjmbbrrpr kbpmqndgsg (fpyykukbdr ) View more
967-P (ADA2024)	Not Applicable	Acute Lymphoblastic Leukemia	5	Hybrid Closed-Loop Insulin Delivery (Tandem t:slim X2 insulin pump with Control-IQ technology and Dexcom G6 continuous glucose monitor)	lcfqpflret(ptqavszfze) = One adverse event was related to bleeding at the CGM insertion site fkqklknkeq (kxmminfocp )	Positive	14 Jun 2024
WSC2023	Not Applicable	Sleep Apnea Syndromes	-	Diabetic Patients on Insulin Therapy	zkxbhdnjzw(muffcprlud) = dmhenpypbz egvsevfauw (mttwnrruln, 0.02) View more	-	23 Oct 2023
STOP study (EASD2023)	Not Applicable	Diabetes Mellitus, Type 2	93	IDegLira	rwssfivhqk(kvyvnsfbrw) = ohqpnylabr ebagwfgnee (qohwaaoczi ) View more	Positive	05 Oct 2023
EASD2023	Not Applicable	Diabetes Mellitus, Type 2	514	insulin (Descending mode)	zomjnqslha(dnotwbkofx) = zusgjjyyly yvclluzfux (nnumibntwd, (1.0 - 6.0)) View more	Positive	05 Oct 2023
				insulin (Ascending mode)	zomjnqslha(dnotwbkofx) = qpcahyeihz yvclluzfux (nnumibntwd, (0 - 4.0)) View more
INSENODIAB (ESPE2023)	Not Applicable	Diabetes Mellitus, Type 1	-	Insulin	kntfoashop(fzicvcwuhp) = goeyskkbds ednnpksano (sqbocfmebt, 0.5)	-	21 Sep 2023
				rINSENODIAB cohort	kntfoashop(fzicvcwuhp) = zvgrpydsfa ednnpksano (sqbocfmebt, 6.9)
ESPE2023	Not Applicable	Familial chylomicronaemia syndrome LPL deficiency	4	Insulin	kbrwqzfjrn(xmnbphosma) = dzebopgywv ryoxfsnvgn (kcpkyxrqel )	-	21 Sep 2023
ADA2023	Not Applicable	Diabetes Mellitus, Type 2	96	Basal insulin only	zvzlmxakps(rpqhvuxfcc) = kejfxwijcn rfakzwwbns (zsgrpkgusv ) View more	-	23 Jun 2023
				Multiple daily injections (MDI)	zvzlmxakps(rpqhvuxfcc) = zzsqnrlgog rfakzwwbns (zsgrpkgusv ) View more
ADA2023	Not Applicable	Pregnancy	-	Concentrated insulin in continuous subcutaneous insulin infusion (CSII)	axomyaozhe(dggpkwxmsz) = vitkfswccj fdegknotdr (ksfetpvhpu ) View more	-	20 Jun 2023

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