| Trial ID: | L3499 |
| Source ID: | NCT06007014
|
| Associated Drug: |
Chiglitazar Sodium
|
| Title: |
Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients|Metformin Combined With Insulin Glargine in the Treatment of Type 2 Diabetes Patients Who Still Have Poor Hypoglycemic Effect|128 Patients Were Randomly Assigned 1:1|Metformin and Insulin Glargine Combined With Chiglitazar Sodium Tablets 48mg/ Day Group|Metformin and Insulin Glargine Combined With Placebo Group|InvestigatorInitiate Trial|Changes in HbA1C From Baseline at 18 Weeks of Treatment
|
| Interventions: |
DRUG: Chiglitazar sodium|DRUG: Chiglitazar placebo
|
| Outcome Measures: |
Primary: HbA1C, Changes in HbA1C from baseline, 18 weeks of treatment | Secondary: Insulin, Changes in the daily dose of insulin from baseline, 6 weeks and 18 weeks of treatment|Triglyceride, Changes in the daily dose of triglyceride from baseline, 18 weeks of treatment|Fasting blood glucose, Changes in the daily dose of fasting blood glucose from baseline, 6 weeks and 18 weeks of treatment|Fasting C-Peptide, Changes in the daily dose of fasting C-Peptide from baseline, 18 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Yanbing Li
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
128
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-10-31
|
| Completion Date: |
2025-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-09-13
|
| Locations: |
the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06007014
|
