Clinical trials: T1DM
Type 1 Diabetes Mellitus
Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System
In this protocol the investigators plan to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged…
- Trial name
- MDB005 (NCT01390259)
- Testing
- Open-Loop, Closed-Loop
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Virginia
Diabetes Mellitus
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM.
- Trial name
- NCT02691247
- Testing
- CLBS03 Low Dose, CLBS03 High Dose
- Where
- 15 sites in United States
- Volunteers
- 113 people
- Sponsor
- Lisata Therapeutics, Inc.
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 Mellitus
Siplizumab in T1DM
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0.
- Trial name
- DESIGNATE (NCT05574335)
- Testing
- Siplizumab
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
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)
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)
Type 1 Diabetes Mellitus
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).
- Trial name
- NCT00870818
- Testing
- Blood samples for safety, Patient reported outcome questionnaires, Analysis of T-cell subsets
- Where
- United States
- Volunteers
- 219 people
- Sponsor
- MacroGenics
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 Mellitus
Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp
An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.
- Trial name
- NCT03369067
- Testing
- Tandem t:slim X2 with Control-IQ Technology + Dexcom G6, Dexcom CGM G5, Continuous Subcutaneous Insulin Infusion
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness…
- Trial name
- NCT02302963
- Testing
- AP System (DiAs or inControl) with USS Virginia
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- University of Virginia
Diabetes Mellitus, Type 1
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8…
- Trial name
- NCT02750267
- Testing
- Diabetes Assistant (DiAs) with Closed-Loop
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Virginia
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
Hypoglycemia
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy…
- Trial name
- NCT03667053
- Testing
- dasiglucagon, GlucaGen HypoKit
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 42 people
- Sponsor
- Zealand Pharma
Diabetes Mellitus, Type 1
Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents
The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels…
- Trial name
- NCT01890954
- Testing
- Diabetes Assistant (DiAs)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Virginia
Type1 Diabetes Mellitus
Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes
The purpose of this study is to reduce the frequency of hypoglycemia and severe hypoglycemic events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM).
- Trial name
- DSS (NCT03093636)
- Testing
- Continuous Glucose Monitor (CGM)+Decision Support System (DSS), Continuous Glucose Monitor (CGM) alone
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus
Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM
This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit…
- Trial name
- NCT00476788
- Testing
- Omnipod Insulin Management System
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham