Clinical trials: T1DM
Diabetes Mellitus, Type 1
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar.
- Trial name
- NCT03341299
- Testing
- LY900014, Insulin Lispro
- Where
- 2 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Eli Lilly and Company
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)
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
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
Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.
- Trial name
- NCT00760526
- Testing
- Continuous glucose monitor, Home blood glucose monitor
- Where
- 5 sites in United States
- Volunteers
- 146 people
- Sponsor
- Jaeb Center for Health Research
Type 1 Diabetes Mellitus
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
The purpose of this study is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.
- Trial name
- NCT02558491
- Testing
- Decision Support System, Usual Care
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Daniel Chernavvsky, MD
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
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
New Strategies for Postprandial Glycemic Control Using Insulin Pump Therapy
Achieving near-normoglycemia has been established as the main objective for most patients with type 1 diabetes (T1DM). However, insulin dosing is an empirical process and its success is highly dependent on the patients' and…
- Trial name
- NCT01550809
- Testing
- iBolus, tBolus (traditional bolus)
- Where
- Spain
- Volunteers
- 12 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
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)
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, Type 1 Diabetes
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer…
- Trial name
- NCT04398030
- Testing
- coil-reinforced soft polymer indwelling cannula, soft Teflon indwelling catheter
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Capillary Biomedical, Inc.
Diabetes Mellitus, Type 1, Overweight and Obesity
ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and…
- Trial name
- ACT1ON DP3 (NCT03651622)
- Testing
- Hypocaloric, low carbohydrate diet, Hypocaloric, moderate low fat diet, Mediterranean diet, no caloric restriction
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.
- Trial name
- NCT02666430
- Testing
- Mylan's insulin glargine, Lantus®
- Where
- 81 sites in United States, Canada and 6 more
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Type1 Diabetes Mellitus
Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients
To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.
- Trial name
- T1DM AP (NCT03353792)
- Testing
- CL/AP system, usual diabetic care
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Yale University
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
Type 1 Diabetes
Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion
This study will be an open-label, cross-over study as subjects will be studied under both study conditions - suspension of subcutaneous insulin infusion via pump during treatment with insulin alone (control) vs.
- Trial name
- NCT02673138
- Testing
- canagliflozin, basal interruption without canagliflozin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Yale University
Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
- Trial name
- inTandem3 (NCT02531035)
- Testing
- Sotagliflozin
- Where
- 135 sites in United States, Argentina and 17 more
- Volunteers
- 1,405 people
- Sponsor
- Lexicon Pharmaceuticals
Type 1 Diabetes Mellitus
T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes.
- Trial name
- Treg (NCT01210664)
- Testing
- Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- University of California, San Francisco