Clinical Trial Details
| Trial ID: | L5071 |
| Source ID: | NCT04124484 |
| Associated Drug: | Dbpr108 Tablet(50mg), Placebo Matching Dbpr108 Tablet(100mg) |
| Title: | DBPR108 Tablets in Type 2 Diabetes Mellitus Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)|DRUG: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)|DRUG: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)|DRUG: Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg) |
| Outcome Measures: | Primary: HBA1c, Changes in HbA1c compared to baseline at week 12, Baseline, week 12 | Secondary: HBA1c, Changes in HbA1c compared to baseline at week 8, week 4, Baseline, week 8, week4|Fasting plasma glucose, Changes in Fasting plasma glucose compared to baseline at week 4,week 8, week 12, Baseline, week 4，week 8, week 12|2-hour postprandial plasma glucose, Changes in 2-hour postprandial plasma glucose compared to baseline at week 4,week 8, week 12, Baseline, week 4，week 8, week 12|fasting glucagon, Changes in fasting glucagon compared to baseline at week 4,week 8, week 12, Baseline, week 4，week 8, week 12|fasting Insulin, Changes in fasting Insulin compared to baseline at week 4,week 8, week 12, Baseline, week 4，week 8, week 12|active Glucagon-like peptide-1（GLP-1）, Changes in active（GLP-1）compared to baseline at week 4,week 8, week 12, Baseline, week 4，week 8, week 12|The percentage of HbA1c≤6.5% or HbA1c≤7%, The percentage of HbA1c≤6.5% or HbA1c≤7% at week 12, week 12|body weight, Changes in body weight（Kg）compared to baseline at week 4,week 8, week 12, Baseline, week 4，week 8, week 12 |
| Sponsor/Collaborators: | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 276 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2017-10-17 |
| Completion Date: | 2019-06-28 |
| Results First Posted: | |
| Last Update Posted: | 2019-10-15 |
| Locations: | First Hospital of Peking Unversity, Beijing, Beijing, China |
| URL: | https://clinicaltrials.gov/show/NCT04124484 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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