| Trial ID: | L3529 |
| Source ID: | NCT05366868
|
| Associated Drug: |
Imeglimin
|
| Title: |
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Imeglimin|DRUG: Metformin|DRUG: Vildagliptin
|
| Outcome Measures: |
Primary: Time from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16., From 16 to 156 weeks after the start of study drug administration | Secondary: Time from Week 0 to addition of a type 2 diabetes mellitus medication after Week 16, From 16 to 156 weeks after the start of study drug administration|Time from detection of two consecutive HbA1c levels of 7.0% or higher to addition of a type 2 diabetes mellitus medication after Week 16., From 16 to 156 weeks after the start of study drug administration|HbA1c level, fasting blood glucose level, and their changes from baseline at each measurement point, From 0 to 156 weeks after the start of study drug administration|Maximum decrease in HbA1c level during the observation period, From 0 to 156 weeks after the start of study drug administration|Proportion of patients achieving HbA1c level less than 7.0% at each measurement point, From 0 to 156 weeks after the start of study drug administration|Number of times of achieving HbA1c level less than 7.0% during the observation period, From 0 to 156 weeks after the start of study drug administration|Time from Week 0 to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16 by patient characteristics, From 0 to 156 weeks after the start of study drug administration
|
| Sponsor/Collaborators: |
Sponsor: National Center for Global Health and Medicine, Japan | Collaborators: Sumitomo Pharma Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
567
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-05-26
|
| Completion Date: |
2027-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-11-09
|
| Locations: |
Center Hospital of the National Center for Global Health and Medicine, Shinjuku-Ku, Tokyo, 162-8655, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT05366868
|
