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Acmopatide Shows Promise in Improving Metabolic Outcomes for Type 1 Diabetes Patients

Acmopatide Shows Promise in Improving Metabolic Outcomes for Type 1 Diabetes Patients

A new signal-based glucagon-like peptide 1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist, acmopatide, has demonstrated positive results in a phase 2 clinical trial for patients with type 1 diabetes who are also overweight or obese. According to Klara Klein, MD, and colleagues at the University of North Carolina at Chapel Hill, preclinical trials indicated that acmopatide improved glycemic control, reduced food intake, and promoted weight loss. The phase 2, double-blind trial involved 111 patients with type 1 diabetes and a BMI of at least 27 kg/m2. Participants were randomly assigned to receive one of three doses of acmopatide (1.8 mg, 4.1 mg, or 6.6 mg) or a placebo. The primary endpoint was the percent change from baseline in hemoglobin A1C (HbA1C) at week 16, with secondary endpoints including changes in body weight and insulin dose. The study found that acmopatide, particularly at the 4.1 mg and 6.6 mg doses, led to significant reductions in HbA1C and body weight, as well as...

The mistake diabetes specialists see after people start GLP-1 meds

The mistake diabetes specialists see after people start GLP-1 meds

Experts say GLP-1 drugs are just one part of diabetes care. Adding a continuous glucose monitor improves results.

China's 30-Day Drug Approval Process Attracts U.S. Biotech First-in-Human Trials

China's 30-Day Drug Approval Process Attracts U.S. Biotech First-in-Human Trials

China's 30-Day Drug Approval Process Attracts U.S. Biotech First-in-Human Trials

Vir Biotechnology Stock Surges Over 10% Following Positive Hepatitis Delta Trial Results

Vir Biotechnology Stock Surges Over 10% Following Positive Hepatitis Delta Trial Results

Vir Biotechnology Stock Surges Over 10% Following Positive Hepatitis Delta Trial Results

AI Integration in Clinical Trials Raises Significant Data Security Concerns for Healthcare and Biotech Sectors

AI Integration in Clinical Trials Raises Significant Data Security Concerns for Healthcare and Biotech Sectors

The increasing integration of Artificial Intelligence (AI) in healthcare and biotech research, particularly within clinical trials, is introducing new and complex data security challenges. While AI is becoming an expected part of daily operations, with 75% of U.S. health systems using at least one AI application, it also creates additional vulnerabilities for sensitive patient records and proprietary research data. Healthcare remains a prime target for cybercriminals, with the average data breach costing $7.42 million and taking 279 days to identify and contain. The 2024 Change Healthcare ransomware attack, which affected 192.7 million individuals due to a single missing control, highlights the severe consequences of security lapses. AI models and their training datasets are now valuable targets for attackers, necessitating robust data protection strategies that extend to every model, dataset, and environment involved in clinical trial information. The FDA and EMA have jointly released ten guiding principl...

American Diabetes Association VP Resigns Amid Editorial Boycott Over NIH Funding Cuts Protest

American Diabetes Association VP Resigns Amid Editorial Boycott Over NIH Funding Cuts Protest

Christian Kohler, Vice President for Professional Publications at the American Diabetes Association (ADA), has resigned in protest over the organization's handling of an editorial boycott. The boycott stemmed from an incident at the ADA's Scientific Sessions conference in June in New Orleans, where five attendees were ejected for distributing copies of a 'Diabetes Care' editorial concerning the impact of National Institutes of Health (NIH) funding cuts. The protest occurred outside the hall where NIH director Jay Bhattacharya was scheduled to speak. Kohler's resignation, submitted on November 6, reflects his profound disappointment with the ADA's response to these events and its failure to resolve the resulting crisis of confidence within the diabetes research community. The journal 'Diabetes Care' has suspended its editorial review of new manuscripts due to the boycott, with approximately 400 manuscripts unhandled since its inception.

Researchers Propose Framework to Standardize Ayurvedic Clinical Trial Protocols

Researchers Propose Framework to Standardize Ayurvedic Clinical Trial Protocols

A team of researchers, including Satyajit Pandurang Kulkarni, Bharat Rathi, Shweta Parwe, and Pallavi Kulkarni, has introduced a methodological framework and eleven candidate reporting extensions aimed at standardizing clinical trial protocols for Ayurvedic whole-system interventions. This proposal builds upon the EQUATOR Network guideline development process, seeking to integrate principles of reproducibility, transparency, and open science into Ayurvedic research. The initiative addresses long-standing challenges in applying conventional protocol reporting frameworks to individualized, multi-modal interventions characteristic of Ayurveda. While the updated SPIRIT 2025 statement includes an open-science section with 34 minimum protocol items, its applicability to the multi-modal logic of Ayurvedic research has been unclear. The proposed framework specifically examines how these open-science provisions can be systematically operationalized within Ayurvedic clinical trials. The candidate extensions are desi...

The supplement behind the C15:0 trend is now available as a gummy

The supplement behind the C15:0 trend is now available as a gummy

The popular Fatty15 supplement is now available in gummy form. Discover the benefits of C15:0, ingredients, flavor and current pricing.

Medicare Part B Expands Coverage for Continuous Glucose Monitors for Seniors with Diabetes

Medicare Part B Expands Coverage for Continuous Glucose Monitors for Seniors with Diabetes

Medicare Part B now provides coverage for Continuous Glucose Monitors (CGMs) for eligible seniors managing diabetes. These small wearable devices continuously track glucose levels in the fluid under the skin, transmitting readings to a receiver or smartphone app. This technology aims to replace frequent finger-stick tests and offers real-time insights into blood sugar fluctuations, alerting users or caregivers to dangerous highs or lows. To qualify for coverage, seniors typically need a diagnosis of Type 1 or Type 2 diabetes managed with insulin, or a documented history of problematic low blood sugar. Additionally, regular blood sugar testing (often four or more times daily) must be part of their current diabetes management. A prescribing physician's order confirming medical necessity and the patient's or caregiver's ability to use the device properly is also required. While insulin use is a common criterion, some non-insulin cases may qualify if hypoglycemia risk is documented.

Organon to Present New Analysis on VTAMA® (tapinarof) Cream for Atopic Dermatitis at ACAAI Meeting

Organon to Present New Analysis on VTAMA® (tapinarof) Cream for Atopic Dermatitis at ACAAI Meeting

Organon to Present New Analysis on VTAMA® (tapinarof) Cream for Atopic Dermatitis at ACAAI Meeting

Novartis-Sponsored Drug Pelacarsen Fails to Prevent Heart Attacks and Strokes in Crucial Study

Novartis-Sponsored Drug Pelacarsen Fails to Prevent Heart Attacks and Strokes in Crucial Study

An experimental drug, pelacarsen, designed to reduce levels of lipoprotein(a) (Lp(a)) in the blood, unexpectedly failed to prevent heart attacks and strokes in a major study. The research, led by cardiologist Steven Nissen of the Cleveland Clinic, involved 8,350 adults with existing heart disease who were given either pelacarsen or a placebo. While the drug successfully suppressed Lp(a) levels by approximately 78%, this reduction did not translate into a decrease in cardiovascular complications over a five-year period. The findings were presented at an American Heart Association meeting in Chicago and published in the New England Journal of Medicine and NEJM Evidence. Drugmaker Novartis, which sponsored the study, had previously announced the study did not meet its goals without releasing specific details, stating only that it provided 'meaningful evidence' about the relationship between Lp(a) and heart disease.

NYU Study Links Earlier Bedtimes to Increased Weight Loss, Independent of Sleep Duration

NYU Study Links Earlier Bedtimes to Increased Weight Loss, Independent of Sleep Duration

A new study from New York University's Rory Meyers College of Nursing suggests that the timing of sleep onset, rather than the total hours slept, is a significant factor in weight loss. The research, led by Assistant Professor Susan Kohl Malone, involved 196 participants aged 21 to 64, all at high risk of developing type 2 diabetes and consistently sleeping less than 6.5 hours per night. Participants were divided into two groups: one receiving an eight-week lifestyle program and another receiving the same program plus sleep coaching. The study found that individuals who went to bed earlier experienced greater weight loss over the eight-week period, a finding that was independent of how many hours they slept. Each hour of earlier bedtime was associated with approximately 1.3 pounds (0.6 kg) of weight loss. The sleep coaching component helped participants retrain their brains to shift to earlier bedtimes and fall asleep quicker.