Regulatory authorities using identical trial data made substantially different decisions regarding both safety and efficacy of hypoglycemic drugs. The differences in initial indication wording between Japan and the other authorities suggest that trial data and T2D are interpreted differently in these regions (British Journal of Clinical Pharmacology)
Diabetes News
Category: Research
Use of Metformin and Cardiovascular Effects of New Classes of Glucose-Lowering Agents: A Meta-analysis of Cardiovascular Outcome Trials in Type 2 Diabetes
As strategy-driven, head-to-head RCTs comparing SGLT-2i, GLP-1RA, or DPP-4i with metformin (and their combination with metformin) while ensuring glycemic and weight equipoise are unlikely to become available in the future, sharing and analyzing individual-level data from already conducted RCT would help to inform the evidence for the best first-line treatment(s) in subjects with type 2 diabetes and confirm or refute our finding (Diabetes Care)
Coded diagnoses from general practice electronic health records are a feasible and valid alternative to self-report to define diabetes cases in research
ICPC-coded diagnoses of DM from general practice electronic health records are a feasible and valid alternative to self-reported diagnoses of DM (Primary Care Diabetes)
Adults with early-onset type 2 diabetes (aged 18–39 years) are severely underrepresented in diabetes clinical research trials
Guidelines for early-onset adult type 2 diabetes are extrapolated predominantly from evidence in older individuals. Strategies to support the participation of individuals with early-onset adult type 2 diabetes in future research are imperative to ensure guidelines for these high-risk individuals are evidence-based (Diabetologia)
How Valid Are the New Hypoglycemia Definitions for Use in Clinical Trials?
The deeper analysis of data from the well-powered SWITCH studies does support that the new IHSG level 2 definition compared with the previous ADA definition can result in statistically more robust findings when comparing insulins (Diabetes Care)
How representative of a general type 2 diabetes population are patients included in cardiovascular outcome trials with SGLT2 inhibitors? A large European observational study
In large T2D populations within Europe, consistent patterns of representativeness of CVOTs were found when applying the main enrolment criteria. The DECLARE‐TMI 58 trial had the highest representativeness, indicating that it included and examined patients who are most representative of the general T2D patients in the studied countries (Diabetes, Obesity and Metabolism)
How Representative are the Patients Included in the CV outcome Trials with SGLT2 Inhibitors of a General Type 2 Diabetes Population?
In large T2D populations from Europe, consistent patterns of representativeness for CVOTs were found when applying main enrollment criteria. DECLARE‐TMI 58 showed the highest representativeness, indicating that it includes and examines patients who are most representative of the general T2D patient in the studied countries (Diabetes, Obesity and Metabolism)
Cardiovascular and mortality events in type 2 diabetes cardiovascular outcomes trials: a systematic review with trend analysis
In contrast to real-world data, there was no evidence of an improvement in all-cause and cardiovascular mortality in type 2 diabetes participants included in control arms of randomised clinical trials across 5 decades. Further studies should investigate whether and how dissimilarities in populations, procedures, and assessments of exposures and outcomes explain the differences between real-world setting and clinical trials (Acta Diabetologica)
Positive 15-month results with Diamyd® in Type 1 diabetes
When all patients have been followed for 15 months in the diabetes trial DIAGNODE-1, where the diabetes vaccine Diamyd® is given directly into the lymph node, a clearly positive and clinically relevant effect is seen in improving the clinical course and maintaining the endogenous insulin production in newly diagnosed type 1 diabetes (Diamyd Medical)
European diabetes research and its funding, 2002–2013
The European diabetes burden in disability-adjusted life years increased by one third between 2002 and 2012, but its output of research papers has decreased from 44% to 36% of the world total. This decrease needs to be reviewed in the context of European non-communicable disease research policy (Diabetic Medicine)
Stepwise reprogramming of liver cells to a pancreas progenitor state by the transcriptional regulator Tgif2
This study uncovers the reprogramming activity of TGIF2 and suggests a stepwise reprogramming paradigm, whereby a ‘lineage-restricted’ dedifferentiation step precedes the identity switch (Nature)
Hypoglycemia Evaluation and Reporting in Diabetes
Importance for the Development of New Therapies
Minority underrepresentation in cardiovascular outcome trials for type 2 diabetes
To determine the clinical trial representation of black or African American people, we reviewed the published data from the seven cardiovascular outcome trials instigated by the 2008 FDA mandate for evaluating cardiovascular risk for new therapies in type 2 diabetes (The Lancet Diabetes & Endocrinology)
Generation of stem cell-derived β-cells from patients with type 1 diabetes
These results show that T1D SC-β cells could potentially be used for the treatment of diabetes, drug screening and the study of β-cell biology (Nature)
Brown Adipose Tissue Exhibits a Glucose-Responsive Thermogenic Biorhythm in Humans
In this study, we explored the relationship between hBAT and glucose metabolism in a series of whole-body and in vitro studies in humans. We hypothesized that hBAT regulates glucose fluxes and plays a determinative role in whole-body glucose homeostasis (Cell Metabolism)
Metabolomics and Type 2 Diabetes: Translating Basic Research into Clinical Application
The use of metabolomics for predicting T2D comorbidities is gaining momentum, as are our approaches for translating basic metabolomics research into clinical applications. As a result, metabolomics has the potential to enable informed decision-making in the realm of personalized medicine (Journal of Diabetes Research)
Generex Provides Update on Success of Buccal Insulin Formulation Enhancement Project
The outstanding results of these dog studies coupled with the positive findings from the in vitro work provide support and confidence to move forward as quickly as possible with the remaining clinical and regulatory work necessary to achieve FDA approval of the enhanced Generex Oral-lyn™ formulation (Generex)
Productivity of authors in the field of diabetes: bibliographic analysis of trial publications
The past two decades have seen an explosive increase in the number of published clinical trials regarding glucose lowering treatment. Some authors have made a disproportionate contribution to the therapeutic evidence base; one third of the RCT evidence base on glucose lowering drug treatment for diabetes was generated by <1% of authors.(BMJ)
The Streetlight Effect in Type 1 Diabetes
In this Perspective, we consider notions in T1D research that should be subject to bold question and provide additional concepts, many somewhat orphan to research efforts, whose investigation could lead to a means for truly identifying the cause of and a cure for T1D (Diabetes)
Role of the gastrointestinal ecosystem in the development of type 1 diabetes
This review examines the current knowledge of the role of the GI ecosystem in T1D and indicates the extensive opportunities for further investigation that could lead to biomarkers and therapeutic interventions for disease prevention and/or modulation (Pediatric Diabetes)
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