Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6457
Source ID: NCT03940183
Associated Drug: Trelagliptin Succinate
Title: Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Trelagliptin Succinate|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: HbA1c, Changes in HbA1c compared to baseline at week 24, Baseline, week 24 | Secondary: HbA1c, Changes in HbA1c compared to baseline at week 16, Baseline, week 16|Fasting blood glucose, Changes in Fasting blood glucose compared to baseline at week 16,week 24, Baseline, week 16,week 24|2-hour postprandial blood glucose, Changes in 2-hour postprandial blood glucose compared to baseline at week 24, Baseline, week 24|fasting insulin, Changes in fasting insulin compared to baseline at week 24, Baseline, week 24|fasting glucagon, Changes in fasting glucagon compared to baseline at week 24, Baseline, week 24|active Glucagon-like peptide-1(GLP-1) level, Changes in active Glucagon-like peptide-1(GLP-1) level compared to baseline at 24, Baseline, week 24|The percentage of HbA1c<6.5% and HbA1c<7%, The percentage of HbA1c\<6.5% and HbA1c\<7% at week 24, week 24|body weight, Changes in body weight(Kg)compared to baseline at week 24, Baseline, week 24|Body Mass Index, Changes in Body Mass Index (kg/m\^2)compared to baseline at week 24, Baseline, week 24
Sponsor/Collaborators: Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 254
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-07-08
Completion Date: 2020-12-28
Results First Posted:
Last Update Posted: 2021-01-12
Locations: Beijing Hospital, Beijing, Beijing, China
URL: https://clinicaltrials.gov/show/NCT03940183