Clinical trials: Type 1 Diabetes Mellitus (T1DM)
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
Concurrent Use of Two Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus (T1DM)
The purpose of this pilot study is to evaluate performance of the SEVEN System and the Navigator System when both devices are worn concurrently by subjects with type 1 diabetes mellitus.
- Trial name
- NCT00939289
- Testing
- Continuous Glucose Monitoring
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- DexCom, Inc.
Hypoglycemia, Diabetes Mellitus, Type 1
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)
- Trial name
- NCT03895697
- Testing
- dasiglucagon
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Zealand Pharma
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
Diabetes Mellitus, Type 1
Subcutaneous Administration of Otelixizumab to T1DM Patients
This study will assess the subcutaneous administration of otelixizumab to T1DM patients. The study will provide safety, tolerability, pharmacodynamic and pharmacokinetic information which will enable the identification of…
- Trial name
- RAO112438 (NCT00946257)
- Testing
- Otelixizumab
- Where
- 6 sites in Belgium
- Volunteers
- 33 people
- Sponsor
- GlaxoSmithKline
Treatment of Type I Diabetes Mellitus.
Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type I Diabetes Mellitus (T1DM) patients.
- Trial name
- NCT01947569
- Testing
- Biological
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- DiaVacs, Inc.
T1DM - Type 1 Diabetes Mellitus
The True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus
The purpose of the investigation is to evaluate the performance of the I3 CGM in Pediatric Patients with Type 1 Diabetes Mellitus (T1DM) according to the FDA's special controls for iCGM.
- Trial name
- NCT05908448
- Testing
- 13 CGM (continuous glucose monitor)
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Sinocare
T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus
An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events
This study is an open-label, single-arm, non-randomized trial designed to evaluate the safety and preliminary efficacy of CRG-002 administered via portal vein infusion or transplantation beneath the anterior rectus sheath in…
- Trial name
- NCT07503028
- Testing
- CRG002
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Celregen Therapeutics
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
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e.
- Trial name
- NCT03176524
- Testing
- BioChaperone® glucagon formulation 1, BioChaperone® glucagon formulation 2, GlucaGen® HypoKit®
- Where
- Germany
- Volunteers
- 27 people
- Sponsor
- Adocia
Type 1 Diabetes Mellitus
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.
- Trial name
- NCT02739906
- Testing
- BioChaperone Human Insulin (HinsBet®), Insulin Lispro (Humalog®), Regular human insulin (Huminsulin® Normal)
- Where
- 2 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Adocia
Type 1 Diabetes Mellitus
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and…
- Trial name
- SUBCUE (NCT01189422)
- Volunteers
- 1 people
- Sponsor
- MacroGenics
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
Healthy, Type 1 Diabetes Mellitus
A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it.
- Trial name
- NCT06280703
- Testing
- LY3938577, Insulin Degludec, Insulin Lispro
- Where
- Germany
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Type 1 Diabetes Mellitus
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
Primary Objective: To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.
- Trial name
- NCT01053728
- Testing
- SAR161271, Insulin glargine HOE901
- Where
- Germany
- Volunteers
- 46 people
- Sponsor
- Sanofi
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 Mellitus (T1DM)
The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.
The goal of this randomized controlled study is to assess the clinical performance and safety of Hedia Diabetes Assistant in adults with type 1 diabetes and suboptimal glycemic control in France.
- Trial name
- TEMPO (NCT06819306)
- Testing
- Hedia Diabetes Assistant
- Where
- 6 sites in France
- Volunteers
- 154 people
- Sponsor
- Hedia ApS
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