Clinical trials: T1DM - Type 1 Diabetes Mellitus
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.
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)
Type 1 Diabetes Mellitus
A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)
The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior…
- Trial name
- NCT02059161
- Testing
- MK-1293, Lantus™, Prandial Insulin
- Volunteers
- 508 people
- Sponsor
- Merck Sharp & Dohme LLC
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, 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, 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
Hypoglycemia
Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of…
- Trial name
- NCT02081014
- Testing
- G-Pen Mini™ (glucagon injection)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Xeris Pharmaceuticals
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, Type 1 Diabetes
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days.
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes Mellitus, Insulin-Dependent, 1
- Trial name
- FEXIS (NCT04503564)
- Testing
- coil-reinforced soft polymer indwelling cannula
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Capillary Biomedical, Inc.
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
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
Type 1 Diabetes Mellitus
Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)
The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in…
- Trial name
- NCT01275131
- Testing
- Insulin aspart, Recombinant human hyaluronidase PH20 (rHuPH20)
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Halozyme Therapeutics
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
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
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating.
- Trial name
- NCT04276207
- Testing
- LY900014, Insulin Lispro
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Type 1 Diabetes Mellitus
A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life.
- Trial name
- CBT (NCT03549104)
- Testing
- Fear Reduction Intervention, Attention Control
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Illinois Chicago
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
Hypoglycemia, Diabetes Mellitus, Type 1
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for hypoglycemia rescue of adult patients with type 1…
- Trial name
- NCT02656069
- Testing
- G-Pen (glucagon injection), Lilly Glucagon (glucagon injection [rDNA origin])
- Where
- 7 sites in United States, Canada
- Volunteers
- 80 people
- Sponsor
- Xeris Pharmaceuticals