Type 2 Diabetes Mellitus (T2DM) Clinical Trial
Official title:
Endovascular Denervation for the Treatment of Type 2 Diabetes Mellitus - a Feasible Clinical Trial Protocol
This is a prospective, multicenter, single group feasibility clinical trial to evaluate the safety and efficacy of Endovascular denervation for the treatment of type 2 diabetes mellitus (T2DM) using the Endovascular denervation system (Generator and Catheter).
This is a prospective, multicenter, single group feasibility clinical trial. Patients with T2DM with poor glycemic control, glycated hemoglobin A1c (Hba1c) between 7.5% and 10.5% treatment with at least one to three oral antidiabetic drugs and/or insulin on the basis of metformin. All eligible patients will accept EDN treatment and were evaluated at 7, 30, 60, 90, 180, 365, 730 days post procedure. The primary safety endpoint is the number of composite major adverse events (MAE) * related to the study device and/or the denervation procedure during procedure and within 30 days after the procedure, the primary efficacy is Hba1c changes from baseline to 6 months post procedure. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05102149 -
Study to Evaluate the Safety and Efficacy of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus
|
Phase 3 | |
| Withdrawn |
NCT03423355 -
Dapagliflozin Effect on Erythropoiesis and Physical Fitness
|
Phase 4 | |
| Terminated |
NCT01923389 -
Multiple Dose Study Of PF-05231023 In Obese Adult Subjects
|
Phase 1 | |
| Completed |
NCT02218099 -
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT05607160 -
A Study to Observe How Insulin Glargine 300 U/ml is Working and is Tolerated in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
|
||
| Completed |
NCT05628090 -
A Study of an Existing Database to Assess the Treatment Persistence to Basal Insulin in Type 2 Diabetes Mellitus Patients in a Structured Patient Education Program in India
|
||
| Completed |
NCT03656744 -
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
|
Phase 2 | |
| Completed |
NCT01002807 -
Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
|
Phase 1 | |
| Recruiting |
NCT04943861 -
Human Immunodeficiency Virus (HIV) Food Insecurities
|
N/A | |
| Completed |
NCT02759107 -
A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)
|
Phase 1 | |
| Completed |
NCT02643797 -
Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
|
Phase 3 | |
| Completed |
NCT05294458 -
A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06327815 -
Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM
|
Phase 4 | |
| Completed |
NCT02219646 -
Diabetes & Vardenafil
|
Phase 2 | |
| Recruiting |
NCT05761301 -
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
|
Phase 1/Phase 2 | |
| Completed |
NCT04504396 -
Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy
|
Phase 3 | |
| Completed |
NCT01991093 -
Multiple Electrode Aggregometry & Clopidogrel Resistance
|
||
| Completed |
NCT01871558 -
Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
|
Phase 3 | |
| Completed |
NCT01407003 -
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1/Phase 2 | |
| Completed |
NCT01127308 -
A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
|
Phase 1 |