| Trial ID: | L1914 |
| Source ID: | NCT02169531
|
| Associated Drug: |
Ex Vivo Activated Immune Cells
|
| Title: |
Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus
|
| Acronym: |
DISC
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Hyperglycemia
|
| Interventions: |
DRUG: ex vivo Activated Immune Cells
|
| Outcome Measures: |
Primary: Change from Baseline Hemoglobin A1c (HbA1c) at up to 27 weeks., Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks. | Secondary: Change from Baseline Lipid Profile at up to 27 weeks., Lipid profile includes cholesterol, triglycerides, HDL cholesterol and LDL cholesterol., Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks. | Other: Change from Baseline Symptoms at up to 27 weeks., The symptoms include insomnia, anorexia, fatigue, frequent trips to the bathroom, unquenchable thirst and blurred vision., Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks.
|
| Sponsor/Collaborators: |
Sponsor: B & Y Technologies | Collaborators: Guangzhou No.12 People's Hospital|The 12th People's Hospital of Shenzhen City
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-03
|
| Completion Date: |
2016-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-01-13
|
| Locations: |
The 12th People's Hospital of Guangzhou, Guangzhou, Guangdong, 510620, China|The 12th People's Hospital of Shenzhen, Shenzhen, Guangdong, 518001, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02169531
|
