Type I Diabetes Clinical Trial
Official title:
Ladarixin 400 mg Twice a Day as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Overweight Insulin-resistant Type 1 Diabetic Patients
Objectives Primary study objective: To determine whether orally-administered ladarixin versus placebo adjunctive therapy improves insulin sensitivity in overweight, insulin-resistant (IR) type 1 Diabetic (T1D) adult subjects. Secondary study objectives: To determine whether orally-administered ladarixin versus placebo adjunctive therapy is safe and well-tolerated in overweight, IR T1D adult subjects.
This study is a randomized, placebo-controlled, double-blinded, 2-arm, 2-period crossover phase II trial using the CXCR1/CXCR2 chemokine receptor antagonist ladarixin versus placebo as adjunctive therapy to insulin to improve insulin sensitivity as well as glucometabolic outcomes in adult, insulin-requiring, overweight, IR T1D patients. This trial will randomize 38 male and female patients 21-65 years of age, inclusive, with established insulinrequiring T1D and IR. After a 2:1 randomization into a treatment sequence (either ladarixin followed by placebo, or placebo followed by ladarixin, respectively), patients will be followed up for a maximum of 53 weeks. The study database will be locked when the last patient randomized has completed visit 9 (week 52/53) and data have been cleaned. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05160142 -
Diabetes Inspired Culinary Education
|
Early Phase 1 | |
| Completed |
NCT01928329 -
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
|
Phase 2 | |
| Completed |
NCT02127762 -
The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy
|
N/A | |
| Completed |
NCT00999375 -
Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
|
Phase 2 | |
| Completed |
NCT04279613 -
A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041
|
Phase 1 | |
| Not yet recruiting |
NCT02117518 -
Selective Immunotargeting of Pathogenic CD8 T Cells of Type 1 Diabetes Patients
|
N/A | |
| Withdrawn |
NCT01477476 -
Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes
|
Phase 2 | |
| Terminated |
NCT01308437 -
Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics
|
Phase 3 | |
| Terminated |
NCT01652911 -
A Phase I/II Study of the Safety and Efficacy of Sernova's Cell PouchTM for Therapeutic Islet Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT06242548 -
How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude
|
N/A | |
| Completed |
NCT00351650 -
Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan
|
N/A | |
| Withdrawn |
NCT00361608 -
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
|
N/A | |
| Terminated |
NCT03653533 -
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
|
N/A | |
| Completed |
NCT00340639 -
Management of Type 1 Diabetes Among Adolescents
|
N/A | |
| Completed |
NCT02002130 -
The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes
|
Phase 1 | |
| Completed |
NCT02634216 -
Effects of Capros in Patients With Type-1 Diabetes
|
N/A | |
| Withdrawn |
NCT01623388 -
Epigenetic Modifications of Diabetes Mellitus Type I
|
N/A | |
| Completed |
NCT02612493 -
Obesity and Metabolic Surgery in Patients With Type I Diabetes
|
N/A | |
| Completed |
NCT01843114 -
Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
|
N/A | |
| Withdrawn |
NCT01398670 -
Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics
|
Phase 3 |