| Trial ID: | L4591 |
| Source ID: | NCT05426018
|
| Associated Drug: |
Sy-009 Capsules
|
| Title: |
The Efficacy and Safety of Different Doses of SY-009 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: SY-009 capsules
|
| Outcome Measures: |
Primary: Changes of HbA1c compared with baseline at 12 weeks, Changes of HbA1c in each dose group compared with baseline at 12 weeks of treatment, 12 weeks | Secondary: Changes of HbA1c compared with baseline at 8 weeks, Changes of HbA1c in each dose group compared with baseline at 8 weeks of treatment, 8 weeks|Changes of maximum blood glucose increase (0-180min) after breakfast compared with baseline at 12 weeks, Changes of maximum blood glucose increase (0-180min) after breakfast in each dose group compared with baseline at 12 weeks of treatment, 12 weeks|Proportion of subjects with HbA1c ≤ 7%, 8 weeks，12 weeks|Proportion of subjects with HbA1c ≤ 6.5%, 8 weeks，12 weeks|Changes of blood glucose at 2h after breakfast compared with baseline, 12 weeks|Changes of insulin at 2h after breakfast compared with baseline, 12 weeks|Changes of C-peptide at 2h after breakfast compared with baseline, 12 weeks|Change of GLP-1 from baseline 2h after breakfast, 12 weeks|Change of GIP from baseline 2h after breakfast, 12 weeks|Change of mean fasting blood glucose from baseline, 12 weeks|Change of fasting blood glucose from baseline, 4 weeks，8 weeks，12 weeks|change of mean blood glucose value at 7 time points from baseline, Based on SMPG test,the change of mean blood glucose value at 7 time points from baseline, 4 weeks，8 weeks，12 weeks|Changes of blood glucose at 2h after meal compared with baseline, Based on SMPG test,the Changes of blood glucose at 2h after meal (breakfast, lunch and dinner) compared with baseline, 4 weeks，8 weeks，12 weeks|Changes in insulin resistance (HOMA-IR) from baseline, 12 weeks|Islet of Langerhans β Cellular function (HOMA- β） Change from baseline, 12 weeks|Blood drug concentration level, 4 weeks，8 weeks，12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-07-01
|
| Completion Date: |
2023-10-01
|
| Results First Posted: |
|
| Last Update Posted: |
2022-06-21
|
| Locations: |
The Second Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China|The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China|The first hospital of Hebei Medical University, Shijiazhuang, Hebei, China|Changsha Central Hospital, Changsha, Hunan, China|Chengdu Fifth People's Hospital, Chengdu, Sichan, China|Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05426018
|
