| Trial ID: | L5332 |
| Source ID: | NCT05054842
|
| Associated Drug: |
Retagliptin Phosphate Tablets、Metformin Sustained-Release Tablets
|
| Title: |
Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Retagliptin phosphate tablets、metformin sustained-release tablets|DRUG: Retagliptin phosphate placebo tablets、metformin sustained-release tablets
|
| Outcome Measures: |
Primary: Changes in HbA1c relative to baseline, After 16 weeks of treatment | Secondary: The proportion of subjects with HbA1c<6.5% and HbA1c< 7% after 16 weeks of treatment, up to 16 weeks of treatment|Changes in fasting plasma glucose relative to baseline, up to 16 weeks of treatment|Changes in 2h postprandial blood glucose relative to baseline, up to 16 weeks of treatment|Changes in body weight relative to baseline, up to 16 weeks of treatment|Percentage of subjects in each group who received remedial treatment, up to 16 weeks of treatment]|The incidence of adverse events of SP2086, From Day 1 to Day 113|The incidence of Hypoglycemic event of SP2086, From Day 1 to Day 113|Evaluate the concentrations of SP2086 in Type 2 diabetes, up to 16 weeks of treatment|Evaluate the concentration of the main metabolite of SP2086 in Type 2 diabetes, up to 16 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
174
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-12-06
|
| Completion Date: |
2023-12
|
| Results First Posted: |
|
| Last Update Posted: |
2023-07-10
|
| Locations: |
Beijing Hospital, Beijing, Beijing, 100000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05054842
|
