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Clinical Trial Details

Trial ID: L2355
Source ID: NCT04161430
Associated Drug: Dbpr108; Placebo Matching Sitagliptin
Title: A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: DBPR108; Placebo matching sitagliptin|DRUG: Placebo matching DBPR108; Sitagliptin; DBPR108|DRUG: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108
Outcome Measures: Primary: Change from baseline in HbA1c (%) compared to placebo comparator at week 24, Change reflects the experimental value (baseline subtract) minus the placebo comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin., Baseline, week 24 | Secondary: Change from baseline in HbA1c (%) compared to active comparator at week 24, Change reflects the experimental value (baseline subtract) minus the active comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin., Baseline, week 24|The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24, Clinical response will be assessed by the percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24., Week 24|Change from baseline in HbA1c (%) at week 12, week 40, week 52, Change reflects the experimental value minus the baseline value at week 12, week 40, week 52. HbA1c represents the percentage of glycosylated hemoglobin., Baseline, week 12, week 40, week 52|The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52, Clinical response will be assessed by the percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52., Week 12, week 40, week 52|Change from baseline in fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24, Change reflects the experimental value minus the baseline value in the fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24. Plasma glucose was measured on a fasting basis or 2 hours after a standard meal, and is expressed as mmol/L. Body weight is expressed as kg., Baseline, week 12, week 24
Sponsor/Collaborators: Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 766
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-01-02
Completion Date: 2022-06-27
Results First Posted:
Last Update Posted: 2022-08-17
Locations: Peking University First Hospital, Beijing, Beijing, 100000, China|the No, 1 People's Hospital of Changsha, Changsha, Huan Province, 410005, China
URL: https://clinicaltrials.gov/show/NCT04161430