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Clinical Trial Details

Trial ID: L2198
Source ID: NCT03141073
Associated Drug: Hms5552
Title: Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: HMS5552|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in HbA1c, The change of HbA1c from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment, 24 weeks | Secondary: The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline, The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment, 24 weeks|The change of fasting plasma glucose (FPG) from baseline, The change of fasting plasma glucose (FPG) from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment, 24 weeks|The proportion of subjects with HbA1c < 7.0%, HbA1c response rate by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment, 24 weeks|The change of HbA1c from baseline at each visit over time, except at Week 24, The change of HbA1c from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects at each visit over time, except at Week 24, 24 weeks|Incidence of Treatment-Emergent Adverse Events over time, including incidence of adverse events, incidence of hypoglycemic events, physical examination, vital signs, 12-lead ECG, clinical laboratory examinations (routine blood test, blood biochemistry and routine urine test)., 52 weeks
Sponsor/Collaborators: Sponsor: Hua Medicine Limited | Collaborators: Covance
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 767
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-10-15
Completion Date: 2021-02-28
Results First Posted:
Last Update Posted: 2021-08-26
Locations: Hua Medicine Limited, Shanghai, China
URL: https://clinicaltrials.gov/show/NCT03141073