Type2 Diabetes Mellitus Clinical Trial
Official title:
Study on the Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion
A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind, placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week double-blind, placebo-controlled treatment phase and a 4-week follow-up phase. Subjects: Type 2 diabetic patients and coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable at time of screening visit, with suboptimal glycaemic control (HbA1c 7.0-8.5%) on their current anti-hyperglycaemic regimen Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo. Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1. The primary Objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity The Secondary Objective is to assess global heart function, and metabolic systemic effects of dapagliflozin, and glycemic control. The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control, and with coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable, who have already undergone, under routine cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to assess the cardiovascular function. Thus, the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice (according to Standards of Care).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04082091 -
Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention
|
||
| Active, not recruiting |
NCT02248311 -
"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population
|
N/A | |
| Completed |
NCT02653300 -
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
|
Phase 2 | |
| Completed |
NCT03655535 -
Multicenter Study to Evaluate the Effect of BTI320 on Glycemic Control in Type 2 Diabetes
|
Phase 2 | |
| Completed |
NCT03256747 -
Effects of Neuromuscular Electrical Stimulation on Glucose Variability in Patients With Type 2 Diabetes
|
N/A | |
| Withdrawn |
NCT03675074 -
Neujia Anastomosis for Treatment of Obesity and Type II Diabetes
|
N/A | |
| Completed |
NCT05343767 -
Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus
|
N/A | |
| Withdrawn |
NCT03190798 -
Effects of Canagliflozin on Intravascular Volume and Hemodynamics
|
Phase 4 | |
| Withdrawn |
NCT03437330 -
Empagliflozin Effect on Glucose Toxicity
|
Phase 4 | |
| Withdrawn |
NCT03008395 -
Empowerment, Motivation and Medical Adherence (EMMA).
|
N/A | |
| Not yet recruiting |
NCT05539066 -
AI Health Assistant and Type 2 Diabetes
|
N/A | |
| Completed |
NCT03682445 -
Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus
|
N/A | |
| Not yet recruiting |
NCT03239119 -
The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT03259789 -
Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
|
Phase 3 | |
| Recruiting |
NCT03506230 -
Financial Incentives for Low Socioeconomic Diabetic Patients
|
N/A | |
| Completed |
NCT03072407 -
MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM
|
Phase 1 | |
| Completed |
NCT05668442 -
Feasibility of an Online Exercise Community Among Individuals With Type 2 Diabetes
|
||
| Completed |
NCT02956044 -
Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin
|
Phase 1 | |
| Completed |
NCT02964572 -
Effect of Sodium Glucose Co-transporter 2 Inhibitor on Inflammatory Cytokine in Type 2 Diabetes
|
N/A | |
| Completed |
NCT02628392 -
A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
|
N/A |