| Trial ID: | L2656 |
| Source ID: | NCT05782192
|
| Associated Drug: |
Sal067
|
| Title: |
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: SAL067|DRUG: Alogliptin|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、week16、week24、week 40 and week 52, Baseline、week 4、week 8、week 12、week16、week24、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|Pancreatic 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: |
458
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-06-13
|
| Completion Date: |
2022-03-25
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-23
|
| Locations: |
1. Sun Yat-sen Memorial Hospital, Sun Yat-sen University,, Guangzhou, Guangdong, 510120, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05782192
|
