Type 2 Diabetes Mellitus

This pilot study will evaluate the feasibility of using a clinical decision support(CDS) message to support consideration of SGLT2 inhibitor prescribing in patients with type 2 diabetes who recently had acute kidney injury. Participating M Health Fairview primary care clinics will be randomized to either receive the clinical decision support intervention or continue usual care. In intervention clinics, providers or clinic pharmacists will receive a message before a scheduled encounter with an eligible patient. The message is intended to support clinical decision-making about SGLT2 inhibitor use, but prescribing decisions will remain with the patient's usual clinical care team. The study will assess feasibility outcomes, including identification of eligible patients, delivery of clinical decision support (CDS) messages, provider/pharmacist receipt of CDS messages, SGLT2i consideration, SGLT2i prescribing, and availability of follow-up kidney function data in the electronic health record.

This observational study will examine the relationships among diabetes distress, practical barriers to medication use, diabetes self-management, and glycemic control in adults with type 2 diabetes. Participants who meet the study criteria and agree to take part will complete questionnaires about their personal and clinical characteristics, diabetes distress, medication-taking barriers, and diabetes self-management. With their permission, the most recent HbA1c result measured within the previous three months will be obtained from their medical record. No treatment or medication changes will be made for this study. The researchers plan to include at least 137 participants.

Type 2 diabetes (T2D) is a principal driver of cardiovascular-renal-metabolic (CKM) syndrome, where metabolic, renal, and cardiac dysfunction accelerate disease progression. This cross-sectional study aims to classify adult patients with T2D attending outpatient clinics at Assiut University Hospitals across CKM stages (0-4) according to the 2023 American Heart Association (AHA) staging system. Additionally, the study identifies independent clinical and laboratory predictors of advanced CKM stages (Stages 3-4) and quantifies the therapeutic gap regarding guideline-indicated organ-protective medications (SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, statins, and MRAs).

This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime. The goal of the study is to investigate the impact of the Accu-Chek SmartGuide CGM solution on the change in overall time in range (TIR) of blood glucose concentrations of 70-180 mg/dl compared with that using self-monitoring of blood glucose (SMBG).

This cross-sectional study aims to evaluate the association of platelet indices and ABO blood groups with vascular complications in patients with type 2 diabetes mellitus.

Cardiovascular disease is the leading cause of illness and death among individuals with type 2 diabetes mellitus (T2DM). Chronic low-grade inflammation contributes significantly to blood vessel damage, atherosclerosis, and diabetic heart complications. Although conventional inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP) and ferritin are commonly measured, they lack specificity and can be altered by various other health conditions. Soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) is an innate immune receptor biomarker linked to cardiac injury and inflammation, but its diagnostic and predictive value in diabetes-associated cardiovascular complications is not yet well established. The primary purpose of this prospective observational study is to evaluate serum sTREM-1 as an immunoinflammatory biomarker for identifying cardiovascular complications in adults with type 2 diabetes, and to compare its diagnostic performance with hs-CRP and ferritin. Adult participants (aged 18-65 years) with established type 2 diabetes undergoing structured cardiac assessment will have a single venous blood sample drawn alongside their clinical examination, electrocardiogram (ECG), and echocardiogram. Biomarker levels will be compared between participants with confirmed cardiac complications (coronary artery disease, heart failure, or arrhythmias) and those without cardiac complications to determine whether sTREM-1 can improve early cardiovascular risk stratification.

Researchers want to understand what happens to muscle and fat in the body after adults with obesity and/or type 2 diabetes start taking a GLP-1 receptor agonist medication (GLP-1RA), a type of drug already approved and commonly prescribed for weight loss and blood sugar control. This is not a drug trial. No experimental medication will be given. Instead, the study will follow people who are already starting this treatment or having their dose adjusted, as part of their regular medical care, and it will not change or interfere with any decision made by the participant's own doctor. These medications help people lose weight, but not all weight loss is the same. Some of it can come from muscle instead of fat, and losing muscle can affect strength and daily function over time. This study will use a scan called DXA (dual-energy X-ray absorptiometry.) to measure how much muscle and fat change over about one year, along with tests of grip strength, walking speed, and everyday physical performance. About 168 adults will take part at two centers in Mexico: the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City and the Instituto de Diabetes, Obesidad y Nutrición in Cuernavaca. After an initial visit, participants will have a phone check-in at 12 weeks and follow-up visits at 24 and 52 weeks, including blood tests, body measurements, and short questionnaires about diet, physical activity, and muscle health. Some participants may also choose to give an extra blood sample for optional genetic testing; this is voluntary and does not affect participation in the main study. There is no placebo, randomization, cost, or payment involved. All treatment decisions remain with the participant's own physician. By observing these changes under real-world conditions, the study aims to help doctors better protect muscle while patients lose fat during treatment with these medications.

The purpose of this study is to assess the safety, tolerability and effectiveness of RF vapor ablation of the proximal intestinal mucosa. This study will test the hypothesis that RF vapor ablation will result in improvement in glycemic parameters, without Serious Adverse Events (SAE) or Unanticipated Adverse Device Effects (UADE).

This study will examine changes in brain and physical health in adults with type 2 diabetes who are initiating incretin-mimetic therapy (e.g., Ozempic, Mounjaro), and determine whether adding structured exercise provides additional benefits. Participants will be randomized to receive incretin-mimetic therapy alone or incretin-mimetic therapy plus a structured exercise program for 24 weeks. If the participant is randomly assigned to the incretin-based therapy alone group, they will have the opportunity to complete the same structured exercise program after the 24-week study period is complete. Brain health will be assessed through cognitive performance, mental health, and brain-mediated appetite regulation. The study will also assess gut microbiota and motor-cortex neuroplasticity as potential factors associated with changes in brain health, as well as glucose regulation, body composition, physical function, and cardiorespiratory fitness. Assessments will be completed at baseline, 8 weeks, and 24 weeks. Findings will help determine how incretin-mimetic therapy and exercise can be integrated to support brain and physical health in adults with type 2 diabetes.

This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8 healthy participants.

Study ASC30-302 (AURORA-2) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight and T2DM.

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

Type 2 diabetes mellitus (T2DM) and periodontal (gum) disease are closely related conditions that may negatively affect each other. However, oral health is not routinely integrated into diabetes self-management education. This study will evaluate whether a structured diabetes-oral health educational intervention based on the Health Belief Model can improve glycaemic control, periodontal health, self-management behaviours, and quality of life among adults with T2DM in Oman. This multicentre randomized controlled trial will include 290 adults with T2DM. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive six individual, structured diabetes-oral health education sessions over 12 weeks in addition to usual care. The control group will continue to receive standard diabetes care and education. Participants will be followed for 12 months. The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 12 months. Secondary outcomes include periodontal health, diabetes and oral-health self-care behaviours, Health Belief Model constructs, quality of life, psychological well-being, diabetes distress, healthcare utilization, and healthcare costs. The study will also assess the cost-effectiveness of the intervention. Exploratory components will assess previously undiagnosed periodontal disease and examine associations between periodontal changes and the oral microbiome.

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

The GLIDE study looks at how the small blood vessels of the eye respond during the first months of a new diabetes medicine. Two widely used classes of glucose-lowering drugs, GLP-1 receptor agonists and SGLT2 inhibitors, are compared in adults with type 2 diabetes who have no diabetic retinopathy or only early (mild) diabetic retinopathy. When blood sugar (HbA1c) falls quickly after starting treatment, the retina can undergo a brief, temporary worsening before it stabilizes and benefits over the long term. This study asks whether it is the speed of that blood-sugar reduction, which we call "glycemic velocity," rather than the specific drug, that drives early changes in retinal and choroidal blood flow. Participants are patients whose own physician has decided, independently of the study, to start one of these two drugs for the first time. The study does not choose, provide, or change any medicine; it adds only eye imaging, blood tests, and observation. Each participant is followed with specialized, non-invasive eye scans, optical coherence tomography angiography (OCT-A) and structural/choroidal OCT, together with HbA1c and other measurements, at the start of treatment and again over the following months. The main measurement is the change, from the start of treatment to month 3, in the density of the tiny deep-layer capillaries at the center of the retina, measured on OCT-A. The study will test whether faster HbA1c reduction is linked to greater early change in these vessels and, using statistical mediation analysis, will estimate how much of any difference between the two drug groups is explained by glycemic velocity versus a direct drug effect. If glycemic velocity, a factor physicians can influence by adjusting how quickly treatment is intensified, turns out to drive early retinal change, the findings could guide safer treatment strategies and help identify patients who need closer eye monitoring when starting these medicines.

This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aims to assess the efficacy, safety, and PK characteristics of DA-302168S tablets in Chinese T2DM participants, and to provide dose-selection evidence for the Phase III confirmatory trial.

Diabetic kidney disease (DKD) is a frequent microvascular complication in individuals with type 2 diabetes mellitus (T2DM) and a major cause of chronic kidney failure worldwide. Chronic low-grade inflammation and platelet activation contribute significantly to renal microvascular damage. The purpose of this observational study is to evaluate whether routine blood test markers, specifically the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and platelet indices (such as mean platelet volume \[MPV\] and platelet distribution width \[PDW\]), can serve as simple, accessible, and cost-effective biomarkers for identifying the presence and progression of diabetic kidney disease. Participants will include adult patients with type 2 diabetes categorized according to their urinary albumin-to-creatinine ratio (normoalbuminuria, microalbuminuria, and macroalbuminuria) as well as healthy control subjects. Complete blood counts, derived inflammatory indices, and renal parameters will be measured to assess their diagnostic accuracy for DKD.

This study aims to evaluate the efficacy and safety of Hebenrun (a functional food based on natural grain bran) combined with metformin in patients with type 2 diabetes mellitus (T2DM). The study hypothesis is that Hebenrun combined with metformin will achieve a higher complete discontinuation rate of oral hypoglycemic drugs compared to metformin alone. A total of 110 T2DM patients will be randomly assigned (1:1) to the study group (metformin + Hebenrun) or the control group (metformin alone) and followed for 48 weeks. The primary outcome is the complete discontinuation rate of oral hypoglycemic drugs at the end of follow-up.

This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.

The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team. The study aims to answer the following questions: 1. Does the CHW program improve diabetes-related health outcomes, such as blood sugar control? 2. What is the sustainability of the program? 3. Is the program feasible and acceptable? Participants will be invited to attend monthly diabetes education classes led by CHWs and receive weekly mobile health check-ins from CHWs for coaching and to help coordinate care with their clinic team.

This randomized controlled trial aims to evaluate the therapeutic effects of pure Ceylon cinnamon (Cinnamomum verum) supplementation combined with a structured self-efficacy-based educational program on glycemic control, lipid profiles, and neuropathic pain in adult patients with type 2 diabetes mellitus (T2DM) and painful diabetic peripheral neuropathy (PDPN). A total of 900 participants will be randomly assigned to three parallel arms: a standard care control group, a Ceylon cinnamon supplementation group (1,000 mg/day), and a combined intervention group (Ceylon cinnamon supplementation plus the self-efficacy educational program) over a 6-month period. The study hypothesizes that the combined approach will significantly improve glycemic parameters, reduce neuropathic pain severity, and enhance metabolic profiles compared to standard care alone.

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)