Clinical trials: T1DM - Type 1 Diabetes Mellitus
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
Diabetes Mellitus, Type 1
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
- Trial name
- NCT02580591
- Testing
- Empagliflozin
- Where
- 189 sites in United States, Australia and 22 more
- Volunteers
- 977 people
- Sponsor
- Boehringer Ingelheim
Type 1 Diabetes Mellitus
Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus
In this protocol the investigators plan to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic…
- Trial name
- MDB003 (NCT01418703)
- Testing
- Closed Loop Control (CLC), Open Loop
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Virginia
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
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
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
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
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
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
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
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 Mellitus
The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
This study will enroll eligible subjects into a long-term safety study (Part B). Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5%…
- Trial name
- NCT02582814
- Testing
- Dapagliflozin 5 mg, Dapagliflozin 10mg
- Where
- 24 sites in Japan
- Volunteers
- 151 people
- Sponsor
- AstraZeneca
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 (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
Hypoglycemia, Diabetes Mellitus, Type 1
A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate…
- Trial name
- NCT03216226
- Testing
- dasiglucagon, GlucaGen
- Where
- 7 sites in United States, Austria and 2 more
- Volunteers
- 112 people
- Sponsor
- Zealand Pharma
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
Effects of Metreleptin in Type 1 Diabetes Mellitus
This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with the aim of lowering the total insulin requirements and suppressing the steep fluctuations typically associated with Type 1 Diabetes.
- Trial name
- NCT01268644
- Testing
- Leptin
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Texas Southwestern Medical Center
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
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, 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)