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Clinical Trial Details

Trial ID: L4174
Source ID: NCT04218734
Associated Drug: Dbpr108
Title: A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: DBPR108|DRUG: metformin hydrochloride|DRUG: placepo
Outcome Measures: Primary: Change in HbA1c (%) from baseline to week 24, The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo, baseline, 24 weeks | Secondary: Percentage of HbA1c ≤ 6.5%, Proportion of patients achieving HbA1c ≤ 6.5% at week 24, 24 weeks|Percentage of HbA1c ≤ 7%, Proportion of patients achieving HbA1c ≤ 7% at week 24, 24 weeks|Change in HbA1c (%) from baseline to week 12, The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo, baseline, 12 weeks|Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24, The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo, Baseline, 12 weeks and 24 weeks|Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24, The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo, Baseline, 12 weeks and 24 weeks|Change in body weight from baseline to week 12 and week 24, The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo, Baseline, 12 weeks and 24 weeks
Sponsor/Collaborators: Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 214
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-01-14
Completion Date: 2021-06-03
Results First Posted:
Last Update Posted: 2021-06-28
Locations: Peking Union Medical College Hospital, Beijing, China
URL: https://clinicaltrials.gov/show/NCT04218734