A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
NCT07061574 ·
Type 1 Diabetes, New Onset
RecruitingThis multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
PhasePhase 1 / Phase 2
TypeInterventional
Age9 Years – 20 Years
WhereSan Francisco, California, United States + 9 more
SponsorCity of Hope Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
NCT07340320 · Type II Diabetes Mellitus
RecruitingThis study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereBirmingham, Alabama, United States + 47 more
SponsorCorxel Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Glucose and Activity Tracking for Sedentary Behavior Interventions in Older People With Type 2 Diabetes (TRACK T2D)
NCT07524205 · Diabetes Mellitus, Type 2
RecruitingThe overarching goal of this explanatory mixed methods study is to evaluate how older people living with type 2 diabetes (T2D) integrate continuous glucose monitor (CGM) and activity data in diabetes self-management, and how this technology supports reduced sedentary behavior (SB) and improved glucose control.
PhaseNA
TypeInterventional
Age55 Years
WhereMinneapolis, Minnesota, United States
SponsorUniversity of Minnesota
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
NCT07351045 · Obesity or Overweight
RecruitingThe 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnniston, Alabama, United States + 202 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
RecruitingThis 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.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 120 more
SponsorBoehringer Ingelheim
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
NCT06112418 · Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome
RecruitingTRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.
PhaseNA
TypeInterventional
Age55 Years
WhereChandler, Arizona, United States + 124 more
SponsorCleerly, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
NCT07533175 · Diabetes Mellitus, Overweight, Obesity
RecruitingThe purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 73 more
SponsorNovo Nordisk A/S
▾Tap for detailsClick for full details — eligibility, all locations, contacts PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
NCT05390892 · Type2Diabetes, ASCVD
RecruitingPRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.
PhasePhase 4
TypeInterventional
Age40 Years – 80 Years
WhereHuntsville, Alabama, United States + 35 more
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System
RecruitingThis multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
PhaseNA
TypeInterventional
Age14 Years – 75 Years
WhereLos Angeles, California, United States + 10 more
SponsorInsulet Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
RecruitingThis project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).
PhaseNA
TypeInterventional
Age18 Years
WhereMinneapolis, Minnesota, United States
SponsorUniversity of Minnesota
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
NCT07564414 · Obesity,
Type 2 Diabetes RecruitingThis clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 302 more
SponsorNovo Nordisk A/S
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
NCT05267626 · Advanced Solid Tumor, Metastatic Cancer,
Cutaneous Melanoma RecruitingThis is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereMiami, Florida, United States + 17 more
SponsorAulos Bioscience, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
NCT07654374 · Obesity, Overweight, Chronic Weight Management
RecruitingThis is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.
PhasePhase 3
TypeInterventional
Age18 Years – 79 Years
WhereBirmingham, Alabama, United States + 73 more
SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus
RecruitingThe 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).
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 208 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
RecruitingThe goal of this clinical trial is to learn if the Diabetes Homelessness Medication Support (D-HOMES) wellness coaching model is effective for adults who speak English or Spanish, have Type 2 diabetes with an HbA1c at or above 7.5, and have recently experienced homelessness. Researchers will compare a one-time education session about diabetes to 10 wellness coaching sessions to see if there are differences between the groups' health outcomes. The main questions it aims to answer are: * Do D-HOMES participants have greater reductions in HbA1c at 3 months than participants who received education? * Do D-HOMES participants have greater reductions in HbA1c at 6 and 12 months compared to those who received education? * Do D-HOMES participants have improvements in blood pressure control, quality of life, self-reported psychological wellness, diabetes distress, and diabetes medication adherence and self-management at 3, 6, and 12 months? * What factors must be considered to make D-HOMES scalable? Participants will: * complete 5 assessments including two baseline assessments and follow-ups at months 3,6, and 12 * participate in a one-time education session or 10 weeks of wellness coaching.
PhaseNA
TypeInterventional
Age18 Years
WhereMinneapolis, Minnesota, United States
SponsorKatherine Vickery
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes
RecruitingA multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks
PhaseNA
TypeInterventional
Age18 Years – 75 Years
WhereLos Angeles, California, United States + 26 more
SponsorInsulet Corporation
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