Type1 Diabetes Mellitus Clinical Trial
Official title:
A Randomized Controlled Trial Comparing 21 Days of Continuous Subcutaneous Insulin Infusion (CSII) Using Hepatic Directed Vesicle (HDV) Insulin to Standard CSII in Type 1 Diabetes Mellitus
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study
This is a single center, double blind, active comparator controlled 2-Way crossover multiple
dose safety, tolerability and efficacy study.
The study will consist of three periods. Total duration will be approximately nine weeks,
including a screening period of up to 14 days, a 7-day run-in period and two 21-day treatment
periods.
Subjects will be screened and then they will undergo a week of baseline CGM. They will then
be randomized to one of two treatment sequences: three weeks of treatment with HDV-lispro
followed by three weeks of treatment with insulin lispro diluted with sterile water to match
the insulin concentration in HDV-lispro, or the same treatments in the reverse order.
A test meal study (standardized liquid test meal) is to be conducted at the beginning of
treatment (baseline study) and at the end of each three week treatment period. As noted
above, frequent blood samples will be collected for glucose and insulin levels during the
first (baseline study) test meal; during the two test meals performed after the two treatment
periods the same sampling for glucose and insulin will be performed, with the addition of
collecting samples for glucagon levels.
Subjects will also perform blinded continuous glucose monitoring throughout the entirety of
the study (7 weeks).
Throughout study, subjects will be asked to perform frequent self-monitoring of blood glucose
(SMBG), at least 6 times per day (before and 60-90 minutes after each meal) during 3 or more
days of each week. This will serve as data for therapeutic decision-making as well as for
data collection.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03623113 -
The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
|
N/A | |
Withdrawn |
NCT03396484 -
Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT03117998 -
Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus
|
Phase 2 | |
Recruiting |
NCT03369821 -
EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)
|
||
Completed |
NCT03202732 -
DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
|
N/A | |
Completed |
NCT03704818 -
Dapagliflozin Effects on Hypoglycemia
|
Phase 1 | |
Recruiting |
NCT03864991 -
Lifestyle Changes and Glycemic Control in T1D
|
N/A | |
Completed |
NCT03725657 -
Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients
|
||
Completed |
NCT02985866 -
The International Diabetes Closed Loop (iDCL) Trial: Protocol 1
|
N/A | |
Completed |
NCT03003806 -
Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study
|
N/A | |
Withdrawn |
NCT04147637 -
FreeStyle Libre Plus Bluetooth Transmitter Adjunct: Can This Improve Glucose Accuracy and Reduce Burden of Hypoglycaemia
|
N/A | |
Completed |
NCT03970889 -
Real-time Reminders To Decrease Late or Missed Meal Boluses
|
N/A | |
Recruiting |
NCT04589325 -
Ixekizumab Diabetes Intervention Trial (I-DIT)
|
Phase 2 | |
Completed |
NCT03367390 -
A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
|
Phase 1 | |
Completed |
NCT03738852 -
Mechanisms for Restoration of Hypoglycemia Awareness
|
Early Phase 1 | |
Completed |
NCT03406585 -
Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes
|
Phase 1/Phase 2 | |
Completed |
NCT03859856 -
Ovarian Reserve in Diabetes Mellitus
|
||
Withdrawn |
NCT04102202 -
BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
|
Phase 1/Phase 2 | |
Terminated |
NCT03353792 -
Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients
|
N/A | |
Recruiting |
NCT03811470 -
China Diabetes Registry by Metabolic Management Center
|