Clinical trials: New Onset
Type 1 Diabetes Mellitus
Rituximab in New Onset Type 1 Diabetes
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas.
- Trial name
- TN05 (NCT00279305)
- Testing
- Anti-CD20 (rituximab)
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 87 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes Mellitus
Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus
The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.
- Trial name
- TN09 (NCT00505375)
- Testing
- CTLA-4 Ig
- Where
- 13 sites in United States, Canada
- Volunteers
- 112 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Dermatomyositis
Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis
This is a 5-year project, involving 185 partners from 46 countries ((110 in 21 European Union (EU) States and 75 in 25 extra-EU States)), with a randomised clinical trials (RCT) in juvenile dermatomyositis (JDM): 5-year phase III…
- Trial name
- PRINTOJDMTR (NCT00323960)
- Testing
- 3 MPDN pulse + PDN, 3 MPDN pulse + PDN + CSA, 3 MPDN pulse + PDN + MTX
- Where
- Italy
- Volunteers
- 139 people
- Sponsor
- Istituto Giannina Gaslini
Type 1 Diabetes
New Onset Type 1 Diabetes: Role of Exenatide
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps…
- Trial name
- NCT01269034
- Testing
- Exenatide, Rapid and long acting insulin, long acting insulin + rapid acting + 1.25 mcg Exenatide
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
Diabetes Mellitus, Type 1
ATG-GCSF in New Onset Type 1 Diabetes
This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects…
- Trial name
- ATG-GCSF (NCT02215200)
- Testing
- Anti-Thymocyte Globulin (ATG), Granulocyte colony stimulating factor (GCSF)
- Where
- 13 sites in United States
- Volunteers
- 89 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
Diabetes Mellitus, Type 1
Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab.
- Trial name
- NCT02000817
- Testing
- Otelixizumab
- Where
- 6 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Type 1 Diabetes Mellitus
Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects
The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes…
- Trial name
- TN08 (NCT00529399)
- Testing
- GAD-Alum, GAD-Alum and Aluminum hydroxide, Aluminum hydroxide
- Where
- 15 sites in United States, Canada
- Volunteers
- 145 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Chronic Graft Versus Host Disease
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
- Trial name
- iNTEGRATE (NCT02959944)
- Testing
- ibrutinib, Prednisone
- Where
- 102 sites in United States, Australia and 13 more
- Volunteers
- 193 people
- Sponsor
- Pharmacyclics LLC.
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)
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
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
Epilepsy
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on…
- Trial name
- NCT02201251
- Testing
- Topiramate, Levetiracetam
- Where
- 41 sites in United States, Argentina and 12 more
- Volunteers
- 63 people
- Sponsor
- Janssen Research & Development, LLC
Type 1 Diabetes Mellitus, New-onset Type 1 Diabetes Mellitus
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the…
- Conditions
- Type 1 Diabetes Mellitus, New-onset Type 1 Diabetes Mellitus, T1DM, T1D
- Trial name
- EXTEND (NCT02293837)
- Testing
- Tocilizumab (TCZ), Standard of Care
- Where
- 19 sites in United States, Australia
- Volunteers
- 136 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
Type 1 Diabetes
Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).
- Trial name
- TIDM (NCT00529191)
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Children's Hospital of Philadelphia
Diabetes Mellitus, Type 1
A Research Trial of Aralast in New Onset Diabetes (RETAIN)
The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to…
- Trial name
- RETAIN (NCT01183468)
- Testing
- Aralast NP 45 mg dose, Aralast NP 90 mg dose, Aralast NP 180 mg dose
- Where
- 15 sites in United States
- Volunteers
- 17 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.
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)
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)