Clinical trials: New Onset
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)
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
Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main…
- Trial name
- EPIC (NCT00097773)
- Testing
- Tobramycin solution for inhalation (TOBI), Oral ciprofloxacin
- Where
- 54 sites in United States
- Volunteers
- 304 people
- Sponsor
- Seattle Children's Hospital
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
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)
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, 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)
Atrial Fibrillation New Onset, Hemorrhage
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
- Conditions
- Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval, Ventricular Tachycardia
- Trial name
- NCT01590979
- Testing
- Ranolazine
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Northwell Health
Atrial Fibrillation New Onset
Shared Decision-Making: AFib 2gether Mobile App
Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™.
- Trial name
- AFib 2gether (NCT04118270)
- Testing
- Afib 2gether TM Mobile Application
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Massachusetts, Worcester
Type 1 Diabetes Mellitus, Maturity-Onset Diabetes of the Young, Type 2
Contribution of Hyperinsulinemia vs. Hyperglycemia to Insulin Resistance in Type 1 Diabetes and Maturity Onset Diabetes of the Young, Type 2 (MODY2)
The purpose of this study is to determine the key factors influencing insulin sensitivity in type 1 diabetes (T1DM) and maturity onset diabetes of the young, type 2 (MODY2).
- Conditions
- Type 1 Diabetes Mellitus, Maturity-Onset Diabetes of the Young, Type 2, MODY2, Insulin Resistance
- Trial name
- NCT02971202
- Testing
- Hyperinsulinemic, euglycemic clamp, 20% dextrose
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Diabetes Mellitus, Adult-Onset
Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression.
- Trial name
- 01-DMPT (NCT01002339)
- Testing
- Tacrolimus with rapid steroid withdrawal, Tacrolimus with steroids minimization, CsA with steroid minimization
- Where
- 10 sites in Spain
- Volunteers
- 134 people
- Sponsor
- Armando Torres Ramírez
Posttransplant Diabetes Mellitus
Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant
The purpose of this study is to determine whether sitagliptin is effective in preventing the development of new-onset diabetes after kidney transplant (NODAT).
- Trial name
- NCT01928199
- Testing
- Sitagliptin
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Washington University School of Medicine
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 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
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
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
Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia
Lasix for the Prevention of De Novo Postpartum Hypertension
Primary objective: To evaluate whether oral furosemide can help prevent de novo postpartum hypertension (new-onset high blood pressure after delivery) by reducing blood pressure after delivery in high-risk women.
- Conditions
- Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia, Hypertension, Pregnancy-Induced, Hypertension
- Trial name
- LAPP (NCT04752475)
- Testing
- Furosemide
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Columbia University
Generalized Myasthenia Gravis
A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis
A randomized, double-blind, placebo-controlled multicenter study evaluating the safety and efficacy of Rituximab (Mabthera®) in patients with new onset generalized myasthenia gravis (MG).
- Trial name
- Rinomax (NCT02950155)
- Testing
- Rituximab, Sodium Chloride solution
- Where
- Sweden
- Volunteers
- 47 people
- Sponsor
- Fredrik Piehl
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
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