Clinical trials: New Onset Type-1 Diabetes
Type 1 Diabetes Mellitus
Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects
The study was a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on…
- Trial name
- CCFZ533X2207 (NCT04129528)
- Testing
- CFZ533
- Where
- 12 sites in Belgium, Germany and 4 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Type 1 Diabetes
Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes
In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
- Trial name
- NCT01390480
- Testing
- Cholecalciferol
- Where
- Austria
- Volunteers
- 31 people
- Sponsor
- Medical University of Graz
Type 1 Diabetes
Pilot Clinical Trial of Ustekinumab in Patients With New-onset T1D
In type 1 diabetes (T1D), immune defense cells in the body attack and destroy insulin-producing beta cells leaving affected people with a lifelong need for daily insulin injections.
- Trial name
- UST1D (NCT02117765)
- Testing
- Ustekinumab
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of British Columbia
Diabetes Mellitus, Type 1
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 [Ala-Ala],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection.
- Trial name
- AbATE (NCT00129259)
- Testing
- Anti-CD3 mAb, Diabetes Standard of Care Treatment, Iron supplementation
- Where
- 7 sites in United States
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diabetes Mellitus, Type 1
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.
- Trial name
- SUNRISE (NCT03895437)
- Testing
- TOL-3021
- Where
- 23 sites in United States
- Volunteers
- 78 people
- Sponsor
- Tolerion, Inc.
T1DM
Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus
Type 1 Diabetes Mellitus (T1DM) is caused by an autoimmune process that progressively destroys the pancreatic β-cells, and leads to dependence on multiple daily insulin subcutaneous injections according to glucose measurements…
- Trial name
- NCT04412200
- Testing
- Hyperbaric oxygen chamber (HBOC)
- Where
- 2 sites in Israel
- Volunteers
- 36 people
- Sponsor
- Assaf-Harofeh Medical Center
New Onset Type-1 Diabetes
Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes.
- Trial name
- NCT02005848
- Testing
- Alpha-1 Antitrypsin
- Where
- 4 sites in Israel
- Volunteers
- 70 people
- Sponsor
- Kamada, Ltd.
Type1 Diabetes
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study
The purpose of this extension study is to continue to follow the participants who completed the CLVer RCT for up to 3 additional years.
- Trial name
- CLVerEx (NCT06177691)
- Where
- 6 sites in United States
- Volunteers
- 77 people
- Sponsor
- Jaeb Center for Health Research
Diabetes Mellitus, Type 1
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the…
- Trial name
- NCT04270942
- Testing
- teplizumab 1 mg/mL
- Where
- 8 sites in United States
- Volunteers
- 6 people
- Sponsor
- Provention Bio, a Sanofi Company
Diabetes Mellitus, Diabetes Mellitus, Type 1
Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients
Study Objects: Diabetes is an autoimmune disease which is mainly caused an immune reaction to beta cells in the pancreas. In this study, mesenchymal stem cells will be used for immune response modulation and improving…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin-Dependent
- Trial name
- MSCTXT1DM (NCT04078308)
- Testing
- Intravenous Injection of autologous mesenchymal stem cells
- Where
- Iran
- Volunteers
- 20 people
- Sponsor
- Royan Institute
Diabetes Mellitus, Type 1
Beta Cell Rescue in New Onset Type 1 Diabetes With Efalizumab
In this single-center therapeutic study, we will study the ability of efalizumab to protect remaining beta cells in teenagers and young adults who have been newly diagnosed with type 1 diabetes mellitus.
- Trial name
- BRiTE (NCT00737763)
- Testing
- efalizumab
- Sponsor
- Emory University
Type 1 Diabetes Mellitus
Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.
- Trial name
- NCT02044848
- Testing
- Secukinumab
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
Severe Hypoglycemia, Type1diabetes
Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes
The GLUREDIA study investigates the counter-regulatory response (CRR) during hypoglycemia in children with type 1 diabetes (T1D).
- Trial name
- GLUREDIA (NCT06770621)
- Testing
- Insulin-induced hypoglycemia test, Glucagon profile, Biological sample once
- Where
- Belgium
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Type1 Diabetes
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
Randomized trial of youth aged 7-<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system…
- Trial name
- CLVer (NCT04233034)
- Testing
- HCL, verapamil 120mg tablet, non-HCL
- Where
- 6 sites in United States
- Volunteers
- 113 people
- Sponsor
- Jaeb Center for Health Research
Diabetes Mellitus, Type 1
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion.
- Trial name
- DEFEND-1 (NCT00678886)
- Testing
- otelixizumab infusion plus physician determined standard of care
- Where
- 109 sites in United States, Canada and 7 more
- Volunteers
- 272 people
- Sponsor
- GlaxoSmithKline
Type1 Diabetes Mellitus
Ixekizumab Diabetes Intervention Trial (I-DIT)
Although the clinical onset of type 1 diabetes (T1D) is acute, the progression of T1D occurs over many years often in a patchy manner with inflammation in certain lobes of the pancreas, leaving other lobes unaffected and…
- Trial name
- I-DIT (NCT04589325)
- Testing
- Ixekizumab
- Where
- 17 sites in Sweden
- Volunteers
- 127 people
- Sponsor
- Göteborg University
New-onset Type 1 Diabetes Mellitus
Study of Antithymocyte Globulin for Treatment of New-onset T1DM
Antithymocyte globulin (e.g., Thymoglobulin®) is an antibody preparation that is commonly used to treat and prevent organ transplant rejection.
- Trial name
- START (NCT00515099)
- Testing
- Antithymocyte globulin
- Where
- 9 sites in United States
- Volunteers
- 58 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes
The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched…
- Trial name
- NCT02867436
- Testing
- Gluten-free diet
- Where
- 2 sites in Czechia
- Volunteers
- 45 people
- Sponsor
- University Hospital, Motol
Type 1 Diabetes Mellitus
Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes
The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D.
- Trial name
- TN25 (NCT03929601)
- Testing
- Rituximab-pvvr, Abatacept, Sterile Sodium Chloride
- Where
- 19 sites in United States, Australia
- Volunteers
- 74 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes
Microbiome in the Acute Stage of New Onset Paediatric Type 1 Diabetes
The goal of this observational study is to learn more about the microbiome and metabolome of children with type 1 diabetes (T1D). The main questions it aims to answer are: 1.
- Trial name
- NCT06157736
- Where
- Ireland
- Volunteers
- 100 people
- Sponsor
- University College Cork