Type2 Diabetes Mellitus Clinical Trial
- Single-center, prospective, active-controlled, open, randomized, 2 arm parallel,
interventional, exploratory pilot
- Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic
control with metformin-based oral hypoglycemic agents will be prescribed glimepiride
(comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days) as
add-on therapy
- Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3
inflammasome activity from baseline to final timepoint will be assessed.
First among cardiovascular (CV) end point trials of glucose-lowering agents, the EMPA-REG
OUTCOME trial-using 10 or 25 mg/day SGLT2 inhibitor empagliflozin against placebo in 7,020
patients with T2DM who were at increased CV risk-reported a 14% reduction in major CV events
and marked relative risk reductions in CV mortality (38%), hospitalization for heart failure
(35%), and death from any cause (32%) over a median time period of 2.6 years. Though these
results have raised the possibility that mechanisms other than those observed in the
trial-modest improvement in glycemic control, small decrease in body weight, and persistent
reductions in blood pressure and uric acid level-may be at play, it's not clearly known yet.
The inflammatory nature of atherosclerosis is well established. We hypothesized that
empagliflozin might have an inhibitory effect on inflammasome activity in macrophages, thus
contribute to cardioprotective effects in diabetes.
- Single-center, prospective, active-controlled, open, randomized, 2 arm parallel,
interventional, exploratory pilot
- Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic
control with metformin-based oral hypoglycemic agents will be prescribed glimepiride
(comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days) as
add-on therapy
- Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3
inflammasome activity from baseline to final timepoint will be assessed
- Healthy volunteers : effect of 3 day-ketogenic diet on changes in cytokines, metabolites
(IL-1beta, beta-hydroxybutyrate , etc) and inflammasome activity in macrophages
;
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 | |
Completed |
NCT05343767 -
Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus
|
N/A | |
Withdrawn |
NCT03675074 -
Neujia Anastomosis for Treatment of Obesity and Type II Diabetes
|
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 |
NCT02628392 -
A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
|
N/A | |
Completed |
NCT03104738 -
Basal Insulin Strategies Before Surgery
|
N/A |