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Clinical Trial Details

Trial ID: L2044
Source ID: NCT05801627
Associated Drug: Sal067
Title: SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: SAL067|DRUG: Placebo
Outcome Measures: Primary: HbA1c change from baseline at week 24, Change From Baseline in Hemoglobin A1c (HbA1c) at week 24, Baseline and week 24 | Secondary: HbA1c change from baseline at week 4,week 12,week 40 and week 52, Change From Baseline in Hemoglobin A1c (HbA1c) at week 4,week 12,week 40 and week 52, Baseline, week 4, week 12, week 40 and week 52|FPG change from baseline at week 4, week 8, week 12, week 16, week 24, week 40 and week 52, Baseline, week 4, week 8, week 12, week 24, week 40 and week 52|Percentage of patients with HbA1c <7.0% and HbA1c <6.5% at week 24 and week 52, Baseline, week 24 and week 52|Percentage of patients required use of rescue therapy at week 24 and week 52, Baseline, week 24 and week 52|Fasting c-peptide change from baseline at week 24 and week 52, Baseline, week 24 and week 52|Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52, Baseline, week 24 and week 52|eatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52, Baseline, week 24 and week 52
Sponsor/Collaborators: Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 408
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-05-06
Completion Date: 2022-05-24
Results First Posted:
Last Update Posted: 2023-04-06
Locations: Peking University Hospital, Beijing, Beijing, China
URL: https://clinicaltrials.gov/show/NCT05801627