Clinical trials: New Onset Type-1 Diabetes
Diabetes Mellitus, Type 1
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo.
- Trial name
- DEFEND-2 (NCT01123083)
- Testing
- Otelixizumab
- Where
- Italy
- Volunteers
- 179 people
- Sponsor
- GlaxoSmithKline
New-onset Type 1 Diabetes Mellitus
Inducing Remission in Type 1 Diabetes With Alefacept
The purpose of this trial is to test whether a drug called alefacept will slow or halt destruction of the beta cells in the pancreas.
- Trial name
- T1DAL (NCT00965458)
- Testing
- Alefacept
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Omeprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients
The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes…
- Trial name
- IIT (NCT01762644)
- Testing
- Oral Cyclosporine and Oral Omeprazole, Oral Omeprazole
- Sponsor
- Perle Bioscience, Inc.
Type 1 Diabetes Mellitus
A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
This was a study designed to evaluate the efficacy of multiple doses of an investigational drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age) patients with new onset type 1 diabetes mellitus…
- Trial name
- NCT00873561
- Testing
- NBI-6024
- Where
- 21 sites in Canada, Czechia and 6 more
- Volunteers
- 188 people
- Sponsor
- Neurocrine Biosciences
Type 1 Diabetes, Preservation of Insulin Secretion
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine.
- Conditions
- Type 1 Diabetes, Preservation of Insulin Secretion, Newly Diagnosed Type 1 Diabetes, Canakinumab in Type 1 Diabetes
- Trial name
- TN14 (NCT00947427)
- Testing
- canakinumab (anti IL-1beta)
- Where
- 12 sites in United States, Canada
- Volunteers
- 71 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Mellitus, Type I, Diabetes Mellitus, Insulin-Dependent, 1
Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus
Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing ß cells. Although exogenous insulin is widely available, it is not possible for affected individuals to consistently achieve euglycemia…
- Conditions
- Diabetes Mellitus, Type I, Diabetes Mellitus, Insulin-Dependent, 1, Type 1 Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus 1
- Trial name
- NCT01781975
- Testing
- Imatinib Mesylate
- Where
- 9 sites in United States, Australia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Type 1 Diabetes Mellitus
Effects of Gluten Free Diet on Type 1 Diabetes Mellitus in Children
The central hypothesis of this proposal is that a gluten-free diet introduced shortly after diagnosis can reverse or arrest islet destruction in children and adolescents with type 1 diabetes mellitus (T1DM).
- Trial name
- NCT02605564
- Testing
- Gluten Free Diet
- Volunteers
- 18 people
- Sponsor
- Loma Linda University
Type 1 Diabetes Mellitus
Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)
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
- UST1D2 (NCT03941132)
- Testing
- Ustekinumab
- Where
- 2 sites in Canada
- Volunteers
- 66 people
- Sponsor
- University of British Columbia
Type 1 Diabetes (T1D)
PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with…
- Trial name
- PRISE-hATG (NCT07670650)
- Testing
- SAB-142
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- University of Florida
Diabetes Mellitus, Type 1
A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
- Trial name
- STRIDE (NCT06025110)
- Testing
- TCD601
- Where
- 26 sites in Belgium, Italy and 3 more
- Volunteers
- 9 people
- Sponsor
- ITB-Med LLC
Diabetes Mellitus, Type 1
A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II
Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug to be tested in this clinical trial.
- Trial name
- RETAIN (NCT01183455)
- Testing
- Aralast NP
- Where
- 15 sites in United States
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in patients with recently diagnosed type 1 diabetes.
- Trial name
- NCT00960635
- Testing
- 1,25-dihydroxy-vitamin D3 (calcitriol)
- Where
- Germany
- Sponsor
- Institut fur Diabetesforschung, Munich, Germany
Type 1 Diabetes, New Onset
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
This 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…
- Trial name
- WAVE T1D (NCT07061574)
- Testing
- Anti-thymocyte globulin (ATG), verapamil extended-release capsule, Adalimumab
- Where
- 11 sites in United States
- Volunteers
- 120 people
- Sponsor
- City of Hope Medical Center
Type 1 Diabetes
Intervention on New Onset-T1D Children
A pilot proof of concept clinical trial will be performed to demonstrate the restoration of gut barrier integrity by administration of beneficial anti-inflammatory gut microbial strains (Lactobacilli-enriched Vivomixx® probiotic)…
- Trial name
- NCT05767450
- Testing
- Probiotic Vivomixx®
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- IRCCS San Raffaele
Diabetes Mellitus Type 1, Autoimmune Diabetes
Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes
Background: Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells (beta cells) in the pancreas, resulting in their death.
- Trial name
- NCT00837759
- Testing
- Insulin, Lansoprazole, Sitagliptin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Mellitus, Type 1
New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial
The objective of this study is to identify immune intervention strategies that will preserve residual beta cell function at the onset of type 1 diabetes.
- Trial name
- TN02 (NCT00100178)
- Testing
- Mycophenolate mofeteil (MMF), Daclizumab (DZB)
- Where
- 11 sites in United States, Canada
- Volunteers
- 126 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Mellitus, Insulin-Dependent
A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes
The objective of this clinical trial is to investigate whether ladarixin has sufficient activity (preservation of β-cell function and slow-down of the progression of T1D) to warrant its further development (proof of concept…
- Trial name
- NCT02814838
- Testing
- Ladarixin
- Where
- 8 sites in Belgium, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Dompé Farmaceutici S.p.A
Diabetes Mellitus, Type 1 Diabetes
Closed Loop From Onset in Type 1 Diabetes
The purpose of the study is to use a novel treatment approach, the artificial pancreas, after diagnosis of type 1 diabetes (T1D) to improve glucose control with the anticipated improvements of residual C-peptide secretion.
- Trial name
- CLOuD (NCT02871089)
- Testing
- Closed-loop system (Florence M or CamAPS FX), Multiple Daily Injections
- Where
- 7 sites in United Kingdom
- Volunteers
- 96 people
- Sponsor
- University of Cambridge
Diabetes Mellitus, Type 1
Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes
In a Pediatric University Teaching Hospital in Montreal, an Intelligent Distance Patient Monitoring Program was developed to allow for: Automatic download of blood glucose levels Automatic alerts indicating hypoglycemias…
- Trial name
- NCT01401790
- Testing
- Telehomecare (Intelligent Distance Patient Monitoring), Standard education and follow up at diabetes clinic
- Where
- Canada
- Volunteers
- 86 people
- Sponsor
- Huot, Celine, M.D.
Diabetes Mellitus, Insulin-Dependent
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin…
- Trial name
- NCT00357890
- Testing
- Insulin pump therapy, Multiple daily injections using insulin glargine + rapid acting analog
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Nemours Children's Clinic