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Clinical Trial Details

Trial ID: L5900
Source ID: NCT04217291
Associated Drug: Sy-004
Title: The Efficacy and Safety of Different Doses of SY-004 in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: SY-004|OTHER: SY-004 matching placebo
Outcome Measures: Primary: Changes in Glycosylated Hemoglobin A1c (HbA1c), Changes in Glycosylated Hemoglobin A1c relative to baseline at 16 weeks compared to placebo., 16 weeks | Secondary: the proportion of subjects whose Glycosylated Hemoglobin A1c (HbA1c) was less than 7%., At the end of 16 weeks, the proportion of subjects whose Glycosylated Hemoglobin A1c was less than 7% ., 16 weeks|The proportion of subjects with Glycosylated Hemoglobin A1c (HbA1c) < 6.5%, The proportion of subjects with Glycosylated Hemoglobin A1c \< 6.5% at 16 weeks after administration of SY-004., 16 weeks|Changes in Glycosylated Hemoglobin A1c (HbA1c), The change of Glycosylated Hemoglobin A1c relative to the baseline after 8 weeks of treatment with SY-004., 8 weeks|the proportion of subjects whose Glycosylated Hemoglobin A1c (HbA1c) was less than 7%, At the end of 8 weeks, the proportion of subjects whose Glycosylated Hemoglobin A1c was less than 7% ., 8 weeks|The proportion of subjects with Glycosylated Hemoglobin A1c (HbA1c) < 6.5%, The proportion of subjects with Glycosylated Hemoglobin A1c \< 6.5% at the end of 8 weeks., 8 weeks|Changes in fasting blood glucose (FPG) relative to the baseline, Changes in fasting blood glucose (FPG) relative to the baseline at 1, 2, 4, 8, 12 and 16 weeks after administration of SY-004., 1、2、4、8、12、16weeks|Changes in postprandial blood glucose auc0-2h, Changes in postprandial blood glucose auc0-2h ( 0-2h blood glucose AUC of Mixed-Meal-Tolerance-Test ) relative to baseline at 16 weeks after administration of SY-004., 16 weeks|Changes in abdominal weight relative to baseline at 8 and 16 weeks., Changes in abdominal weight relative to baseline at 8 and 16 weeks after administration of SY-004., 8、16weeks
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: 2019-12-10
Completion Date: 2021-07-09
Results First Posted:
Last Update Posted: 2022-05-18
Locations: PLA General Hospital, Beijing, Beijing, 100853, China
URL: https://clinicaltrials.gov/show/NCT04217291