Clinical trials: New Onset Type-1 Diabetes
Type 1 Diabetes Mellitus
A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes
The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous…
- Trial name
- DIAGNODE-3 (NCT05018585)
- Testing
- Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®, Colecalciferol 2000 IU
- Where
- 60 sites in United States, Czechia and 7 more
- Volunteers
- 321 people
- Sponsor
- Diamyd Medical AB
New-onset Type 1 Diabetes
A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.
The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes (T1D) adult patients with preserved β-cell function.
- Trial name
- NCT04899271
- Testing
- Ladarixin
- Where
- 16 sites in United States, Belgium and 4 more
- Volunteers
- 25 people
- Sponsor
- Dompé Farmaceutici S.p.A
Treatment of Type I Diabetes Mellitus.
Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type I Diabetes Mellitus (T1DM) patients.
- Trial name
- NCT01947569
- Testing
- Biological
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- DiaVacs, Inc.
Diabetes Mellitus, Type 1
Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus
This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre study of 52 weeks treatment duration.
- Trial name
- NCT02284009
- Testing
- Albiglutide weekly injection, Insulin
- Where
- 32 sites in France, Germany and 3 more
- Volunteers
- 67 people
- Sponsor
- GlaxoSmithKline
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
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
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, 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
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
- Trial name
- NCT07222332
- Testing
- Baricitinib
- Where
- 131 sites in United States, Australia and 18 more
- Volunteers
- 300 people
- Sponsor
- Eli Lilly and Company
Type 1 Diabetes
SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes
This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).
- Trial name
- SAFEGUARD (NCT07187531)
- Testing
- High Dose SAB-142, Low Dose SAB-142
- Where
- 68 sites in United States, Australia and 13 more
- Volunteers
- 159 people
- Sponsor
- SAb Biotherapeutics, Inc.
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
Diabetes Mellitus, Type 1
Immune Profile in Subjects With New Onset Type 1 Diabetes
It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes (iLN), which will be distinct from changes observed…
- Trial name
- NCT02801942
- Testing
- Inguinal lymph node fine needle aspirate biopsy, Inguinal lymph node core biopsy, Peripheral blood collection
- Where
- 2 sites in United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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, 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
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.
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
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
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
Type 1 Diabetes Mellitus
Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with…
- Trial name
- NCT02093221
- Testing
- 180 mg/kg Alpha1-PI, 90 mg/kg Alpha1-PI
- Where
- 36 sites in United States
- Volunteers
- 76 people
- Sponsor
- Grifols Therapeutics LLC