Type II Diabetes Clinical Trial
Official title:
An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrierâ„¢ Liner vs. Diet Control for the Treatment of Type 2 Diabetes
The purpose of this study is to evaluate the safety and efficacy of a second generation
EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.
This is a randomized, controlled study which will enroll approximately 70 Subjects with Type
2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device
Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will
be offered the EndoBarrier device after 12 months on study at the investigator's discretion
if treatment of the device subjects indicates adequate efficacy. This study will be
conducted at three (3) investigational sites.
The primary efficacy endpoint is:
- Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24
weeks or last visit from baseline between the two groups.
Secondary endpoints are:
- Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit
from baseline.
- Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or
discontinued at week 24 or last visit from baseline.
- Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced
by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from
baseline.
- Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.
- Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12
months.
- Compare physical component summary (PCS), mental component summary (MCS) and quality
adjusted life years (QALYs)via analysis of the SF-36v2 QOL.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04569214 -
The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients
|
Phase 2 | |
| Completed |
NCT02127762 -
The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy
|
N/A | |
| Completed |
NCT01698528 -
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
|
N/A | |
| Active, not recruiting |
NCT05120219 -
A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04893135 -
Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes
|
N/A | |
| Not yet recruiting |
NCT05108350 -
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT02586129 -
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
|
Phase 3 | |
| Completed |
NCT02914743 -
Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes
|
N/A | |
| Completed |
NCT04540016 -
Mass Balance and Biotransformation of [14C]HSK7653 in Human
|
Phase 1 | |
| Completed |
NCT02429258 -
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
|
Phase 4 | |
| Completed |
NCT01055223 -
Fracture Risk With Thiazolidinediones
|
N/A | |
| Terminated |
NCT02365233 -
Fatty Liver Study in Patients With Type II Diabetes
|
Phase 4 | |
| Completed |
NCT05878587 -
Burger Allen Exercises in Knee OA With Type II Diabetes
|
N/A | |
| Completed |
NCT04768673 -
A Study to Investigate the PK and Safety of CKD-393
|
Phase 1 | |
| Not yet recruiting |
NCT05028140 -
Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
|
Phase 3 | |
| Terminated |
NCT01804777 -
Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes
|
Early Phase 1 | |
| Completed |
NCT01619332 -
Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06387433 -
Effectiveness of an mHealth Mobile App
|
N/A | |
| Not yet recruiting |
NCT01591525 -
Diabetes Mellitus Community Based Screening in Minority Populations
|
N/A | |
| Completed |
NCT01881074 -
Periodontal Treatment Response in Type II Diabetic Patients
|