| Trial ID: | L5015 |
| Source ID: | NCT06789302
|
| Associated Drug: |
Dt2-Sct Intravenous Infusion
|
| Title: |
A Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of DT2-SCT in Subjects with Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: DT2-SCT intravenous infusion|OTHER: Placebo
|
| Outcome Measures: |
Primary: Incidence of Treatment-Emergent Adverse Events (TEAEs) Occurring in Less Than 5% of Participants, 30 months|Change from Baseline in Insulin Requirements at 6 Months Post-Treatment, 30 months | Secondary: Change from Baseline in Glucagon-Stimulated C-Peptide Levels at 6 Months Post-Treatment, 30 months|Change from Baseline in HbA1c Levels, 30 months
|
| Sponsor/Collaborators: |
Sponsor: Global Institute of Stem Cell Therapy and Research
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2025-06
|
| Completion Date: |
2027-12
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-23
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06789302
|
