Clinical Research Directory

A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to * Part A: healthy eating and physical activity * Part B: diabetes tablets (no injection of insulin) * Part C: injection of insulin (with or without diabetes tablets) Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment. Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)

The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood. The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week. About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective. People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.

Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)

The goal of this clinical trial is to learn if starting four kidney disease medicines quickly and together (a rapid treatment approach) is safe and works well in people with type 2 diabetes and chronic kidney disease. The main questions it aims to answer are: * Is it safe to start these medicines over a short period of time? * How often do kidney function changes or high potassium levels occur? * Does this approach lower protein in the urine (a sign of kidney damage)? * How many participants are able to stay on all four medicines over 6 months? Researchers will compare this approach to usual care, where medicines are started one at a time over several months. Participants will: Be assigned by chance to either this approach or usual care Start up to four approved kidney medicines over about 8 weeks (rapid treatment approach) or follow standard care Have regular clinic visits and lab tests to check kidney function and potassium levels Be followed for about 6 months

A Food-Effect Study of CX11 in Healthy Participants

This study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants

Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

This is a randomized, double-blind, placebo-controlled clinical trial. The objective of this trial is to determine whether Lactobacillus paracasei LC19 supplementation has a positive effect on glucose lowering in patients with type 2 diabetes (T2D).

Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes

The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.

LIfestyle MEtabotype Study A

Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose response to food intake remain poorly investigated. The aim of the LIfestyle MEtabotype study (LIME) observational study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes \[T2D\], and absence of prediabetes or T2D). To address this aim, the study will conduct a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping during study center visits and a dietary, glucose, sleep and activity monitoring during the observational phase.

MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study

The goal of this observational study is to understand how metabolic dysfunction-associated steatotic liver disease (MASLD) changes over time in individuals with type 2 diabetes who previously participated in the EPSONIP study. The main questions it aims to answer are: 1. How common are MASLD and advanced liver fibrosis at long-term follow-up? 2. Which factors are associated with progression or regression of liver fat accumulation and liver fibrosis over time? Participants will: * Undergo a clinical examination and review of medical history. * Provide blood, urine, and biobank samples. * Undergo liver assessment using vibration-controlled transient elastography (VCTE). * Undergo magnetic resonance imaging (MRI) to assess liver fat, liver fibrosis, and body composition. * Complete questionnaires regarding lifestyle and physical activity. * Undergo physical activity measurements using accelerometers and additional assessments related to blood pressure and sleep apnea.

Effect of Interactive Video-Based Self-Management Education in Adults With Type 2 Diabetes

This study aims to evaluate the effectiveness of an interactive video-based self-management education program for adults with type 2 diabetes. The education program is designed to support individuals in managing their daily diabetes care and improving their blood glucose control. Participants in this study will be adults diagnosed with type 2 diabetes who are receiving outpatient care. Eligible participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive an interactive video-based education program developed according to the AADE7 Self-Care Behaviors framework. The videos are based on real-life scenarios and encourage active participation and decision-making. Participants in the control group will receive standard diabetes care. The study will assess changes in blood glucose control, diabetes self-management behaviors, and empowerment levels over the study period. Data will be collected using clinical measurements and questionnaires. Participation in this study is voluntary. The results of this study may contribute to improving diabetes education practices and supporting patient-centered care in clinical settings.

A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Tirzepatide Medication

The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of tirzepatide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get tirzepatide and zenagamtide.

Tracking Income Dynamics and Everyday Health Study

Among adults with chronic illnesses like hypertension, diabetes, or HIV, adherence to daily oral medications is essential but often below 50%. Why do medication adherence and preventive health service engagement remain stubbornly low? Scarcity theory offers a novel explanation in the context of poverty. It posits that economic hardship imposes a cognitive burden that shifts attention from long-term goals to immediate needs, reduces future orientation (the relative value placed on immediate vs. future outcomes), and limits mental bandwidth (the cognitive resources needed for decisions), thus undermining behaviors like daily medication adherence and service engagement. To address these gaps, the study's objective is to rigorously test whether and how economic scarcity affects medication adherence and preventive service uptake among older adults with chronic disease, leveraging the naturally occurring monthly fluctuation in scarcity created by the Supplemental Nutrition Assistance Program (SNAP) benefit cycle as a natural experiment. There are three aims: 1. Daily medication adherence will be measured objectively for four months with wireless electronic pill bottle caps (CleverCaps). The investigators will test whether, when, and by how much adherence changes as scarcity fluctuates during the SNAP benefit cycle. 2. The investigators will conduct two easily implementable RCTs to test whether scarcity affects participants' engagement with beneficial services requiring navigation of administrative burdens. In one trial, participants will be randomized to receive an invitation during either a high- or low- scarcity period (i.e., before vs. after SNAP receipt) to a personalized preventive health review that identifies gaps in US Preventive Services Task Force Grade A/B recommendations. In the second, participants will be invited to free financial counseling provided by the City of Philadelphia during a high- or low-scarcity period. The investigators hypothesize invitation response rates will be \>15% higher during low-scarcity periods. 3. Potential mechanisms that link scarcity with health behaviors will be examined by randomizing timing of validated measures of mental bandwidth and future orientation during a period of high- or low-scarcity (i.e., before vs. after SNAP receipt). The investigators hypothesize that there will be differences in several measures between participants who are randomly assessed during high- vs. low-scarcity periods (i.e. before vs. after SNAP receipt). Impact: Demonstrating that scarcity helps to explain low medication adherence and beneficial health-related service uptake can inform patient-centered adherence interventions, clinical care-delivery approaches, health-system strategies, and public health approaches to improve these health behaviors and promote healthy aging.

A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Multimodal Glucose Prediction in Type 2 Diabetes

The primary objective of this research, funded by Samsung Strategic Alliance for Research and Technology, is to develop multi-modal foundation models that integrate Continuous Glucose Monitoring (CGM) data with patient behavior data (food intake, medication, and physical activity) to improve real-time glucose prediction and personalized diabetes management for patients with Type 2 diabetes (T2D), delivered via mobile apps and digital health tools.

Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)

The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.

Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults

The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes. Some metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can: 1. Improve how well the body produces insulin and responds to it, 2. Improve the quality of the particles that carry "bad" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue. To answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA. When included in this study, participants will: A) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.

DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care

GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring. It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.

Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes

This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

DigiDiab Pilot: Impact Study Hospital

GlucoTab is an innovative workflow and decision support tool for standardised diabetes management by healthcare professionals which provides automated and personalised dosage recommendations for different insulin therapy regimens.

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).

Advancing Diabetes Management for People With Physical Disabilities Optimally Through Primary Care-Based Telehealth (ADDOPT)

The purpose of the study is to compare 2 primary care based telehealth interventions- 1) digital health coaching and 2) remote patient monitoring for improving glycemic (blood sugar levels) control and overall health outcomes in individuals with physical disabilities, type 2 diabetes (T2DM) and at least one chronic condition. The project aims to determine which intervention is more effective in reducing blood sugar levels, improving patient-reported outcomes such as diabetes-related distress, and facilitating the implementation of these approaches in real-world primary care settings serving vulnerable populations. The findings intend to inform about optimal telehealth strategies for managing multiple chronic conditions in underserved groups, there by supporting improved health equity and quality of care.

SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.

Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes

It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.

The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial

The hypothesis for this study is that oral Semaglutide, a GLP-1Ra, has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 50-85 years with type 2 diabetes and an increased risk of bone fractures. Treatment involves once daily oral GLP-1Ra semaglutide or matching placebo for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue and bone marrow tests (bone marrow aspiration and biopsy), physical activity assessed by a questionnaire, and direct bone strength measured by microindentation at the start and end of the study.