Clinical trials: T1DM - Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)
The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII)…
- Trial name
- HALO-117-406 (NCT03662334)
- Testing
- Rapid Acting insulin with pre-treatment of rHuPH20
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Halozyme Therapeutics
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
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
The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥…
- Trial name
- NCT02582840
- Testing
- Dapagliflozin 5mg, Dapagliflozin 10mg
- Where
- Japan
- Volunteers
- 42 people
- Sponsor
- AstraZeneca
Hypoglycemia, Diabetes Mellitus, Type 1
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo
- Trial name
- NCT03688711
- Testing
- Dasiglucagon
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Zealand Pharma
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
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, Pregnancy
Orchestra Pregnancy Observational Study in Poland
The aim of this project is to document the use of insulin pump therapy (CSII), including sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1 Diabetes Mellitus benefiting from the Orchestra…
- Trial name
- NCT01779141
- Where
- 24 sites in Poland
- Volunteers
- 481 people
- Sponsor
- Medtronic MiniMed, Inc.
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)
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
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)
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
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 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
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
Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
Primary Objective: •To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin…
- Trial name
- GLITTER1 (NCT03371082)
- Testing
- Gan & Lee Insulin Glargine Injection, Lantus®
- Where
- 85 sites in United States, Czechia and 4 more
- Volunteers
- 576 people
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Type 1 Diabetes
A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus
VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.
- Trial name
- VC01-103 (NCT04678557)
- Testing
- VC-01 Combination Product
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- ViaCyte
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
CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)
The primary objectives of this study are to compare the difference in glycosylated hemoglobin (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous subcutaneous insulin infusion (CSII) versus…
- Trial name
- NCT01848990
- Testing
- Commercial Hylenex® recombinant (hyaluronidase human injection), Precommercial Hylenex recombinant (hyaluronidase human injection), Insulin lispro
- Where
- 39 sites in United States
- Volunteers
- 456 people
- Sponsor
- Halozyme Therapeutics
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