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
Hypoglycemia
PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to…
- Trial name
- NCT02081001
- Testing
- Novo Nordisk GlucaGen®, G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Xeris Pharmaceuticals
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
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
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
Diabetes Mellitus, Type 1, Type 1 Diabetes
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and…
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Diabetes, Autoimmune, Diabetes type1
- Trial name
- NCT05168657
- Testing
- Bionic Pancreas, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- University of Colorado, Denver
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
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
Diabetes Mellitus, Type 1
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).
- Trial name
- NCT02139943
- Testing
- Canagliflozin 100 mg, Canagliflozin 300 mg
- Where
- 53 sites in United States, Canada
- Volunteers
- 352 people
- Sponsor
- Janssen Research & Development, LLC
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
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
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
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
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
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
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, 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
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
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
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