Diabetes Mellitus Type 1 Clinical Trial
Official title:
A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.
For the first 3 days, patients will be dosed with placebo 45 minutes prior to each of the
day's 3 meals to establish baseline insulin requirements. Patients will be dosed with
exogenous insulin according to their normal sliding scale and each patient's daily insulin
requirement will be documented. The average daily insulin requirements during the 3 day
run-in period will constitute the patient's baseline insulin level.
Following the 3 day run-in, the CGM device will be detached, its data download, and the
patient refitted with the CGM with a fresh cannula for continued monitoring during the 7-day
treatment period.
Patients will be randomized 2:1 to receive ORMD-0801 or placebo for the 7-day double-blind
treatment period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01508065 -
Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
|
||
| Completed |
NCT01788033 -
Effects of XOMA 052 on Insulin Production in Type 1 Diabetes
|
Phase 2 | |
| Active, not recruiting |
NCT01271517 -
Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis
|
Phase 4 | |
| Recruiting |
NCT01800734 -
Mixed Meal Test in Type 1 Diabetes: Optimization of Artificial Pancreas-Pilot Study
|
Phase 4 | |
| Recruiting |
NCT06088615 -
Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry
|
||
| Completed |
NCT02127047 -
Effects of Exercise and Inhibition of Dipeptidyl Peptidase-4 on Insulin Secretion in Subjects With Type 1 Diabetes
|
Phase 2 | |
| Completed |
NCT01689090 -
Diameter Changes of Retinal Vessels During Hypoxia
|
N/A | |
| Completed |
NCT00006505 -
Solitary Islet Transplantation for Type 1 Diabetes Mellitus Using Steroid Sparing Immunosuppression
|
Phase 2 | |
| Not yet recruiting |
NCT06217302 -
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
|
Phase 3 | |
| Recruiting |
NCT02750111 -
Continuous Glucose Monitoring During Intecorse in Young Adults With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT02545062 -
MoCa Test for the Early Detection of Mild Cognitive Impairment During Annual Assessment of Young Adults With Diabetes and in a Control Group Without Diabetes
|
N/A | |
| Completed |
NCT02146651 -
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
|
Phase 2 | |
| Completed |
NCT02538120 -
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients
|
N/A | |
| Completed |
NCT02403375 -
Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes
|
N/A | |
| Terminated |
NCT00896610 -
Natural History of Autoimmune Diabetes and Its Complications
|
||
| Terminated |
NCT02701257 -
The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
|
N/A | |
| Completed |
NCT01334151 -
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
|
Phase 1 | |
| Active, not recruiting |
NCT02624804 -
A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
|
Phase 1 | |
| Completed |
NCT02465411 -
Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections
|
N/A | |
| Completed |
NCT02157155 -
A Study of Intracellular Signaling in Muscle and Fat Cells During Ketosis
|
N/A |