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Clinical Trial Details

Trial ID: L2933
Source ID: NCT03414892
Associated Drug: Globalagliatin Hydrochloride
Title: Multiple Ascending Doses of Globalagliatin Hydrochloride in Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hyperglycaemia (Diabetic)|Type 2 Diabetes Mellitus
Interventions: DRUG: Globalagliatin Hydrochloride|DRUG: Placebo
Outcome Measures: Primary: the mean change in glucose area under curve (AUC) from baseline., Compared with placebo, the mean change in glucose AUC from baseline at D28., 28 days | Secondary: the fasting plasma glucose from baseline, Compared with placebo, the fasting plasma glucose from baseline at D7,D14,D21 and D28., 7, 14, 21, 28 days|the changes of MMTT (mixed-meal tolerance test) results from baseline, Compared with placebo, the changes of MMTT (mixed-meal tolerance test) results from baseline at D28, 28 days|the mean changes of average 7-points blood glucose profiles from baseline, Compared with placebo, the mean changes of average 7-points blood glucose profiles from baseline at D7,D14,D21 and D28., 7, 14, 21, 28 days|the mean changes of average 14-points blood glucose profiles from baseline, Compared with placebo, the mean changes of average 14-points blood glucose profiles from baseline at D7,D14,D21 and D28., 7, 14, 21, 28 days|the mean changes of post-prandial blood glucose from baseline, Compared with placebo, the mean changes of post-prandial blood glucose from baseline at D7,D14,D21 and D28., 7, 14, 21, 28 days | Other: genetic: TCF7L2 ( Transcription factor 7-like 2) rs7903146 and GCKR (glucokinase regulatory protein) rs780094 ), The genetic(TCF7L2 rs7903146 and GCKR rs780094)effects on response of SY-004 in T2DM patients., 28 days|the changes of GA (Glycated albumin) from baseline, Compared with placebo, the changes of GA (Glycated albumin) from baseline at D28., 28 days
Sponsor/Collaborators: Sponsor: Yabao Pharmaceutical Group
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2018-01-03
Completion Date: 2019-12-01
Results First Posted:
Last Update Posted: 2020-01-03
Locations: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
URL: https://clinicaltrials.gov/show/NCT03414892