Type2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of JY09 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
This study was designed as a multicenter, randomized, open, parallel, positively controlled Phase III clinical study to evaluate the efficacy and safety of Exendin-4Fc fusion protein (JY09) injection in adult subjects with type 2 diabetes mellitus who have poor glycemic control after metformin treatment only. The proposed plan is to enroll 600 subjects with T2DM, using stratified block group randomization with the stratification factor being baseline HbA1c (≤8.5% or >8.5%), and randomly assign them to the 1.2 mg JY09 injection group (n=200 subjects), 2.4 mg JY09 injection group (n=200 subjects) and dulaglutide injection group (n=200 subjects) in a 1:1:1 ratio. The trial was divided into 4 phases, i.e., a screening period of 2 weeks, an introduction period of 4 weeks, a treatment period of 54 weeks (26 weeks for the core treatment period and 28 weeks for the extended treatment period), and a safety follow-up period of 4 weeks. A total of 64 weeks. ;
| 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| Withdrawn |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| Withdrawn |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 |