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Clinical Trial Details

Trial ID: L6198
Source ID: NCT02750007
Associated Drug: Hs-20004
Title: Tolerability to HS-20004 With Titration Administration in Type 2 Diabetic Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: HS-20004
Outcome Measures: Primary: Number of Treatment Emergent Adverse Events(TEAEs), through study completion, an maximum of 8 weeks | Secondary: Number of Nausea and vomiting during titration, through study completion, an maximum of 8 weeks|Mean Change From Baseline in Body Weight at different dose steps, through study completion, an maximum of 8 weeks|Change in plasma concentration of HS-20004 from baseline at different dose steps, through study completion, an maximum of 8 weeks|Change in plasma concentration of glucose from baseline at different dose steps, through study completion, an maximum of 8 weeks|Change in plasma concentration of insulin from baseline at different dose steps, through study completion, an maximum of 8 weeks|Change in plasma concentration of glucagon from baseline at different dose steps, through study completion, an maximum of 8 weeks|The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients, through study completion, an maximum of 8 weeks
Sponsor/Collaborators: Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-12
Completion Date:
Results First Posted:
Last Update Posted: 2016-04-25
Locations: The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
URL: https://clinicaltrials.gov/show/NCT02750007