| Trial ID: | L1851 |
| Source ID: | NCT03513874
|
| Associated Drug: |
Metformin
|
| Title: |
Metformin Plus Insulin on Non-obese Autoimmune Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus|Autoimmune Diabetes
|
| Interventions: |
DRUG: Metformin|DRUG: Insulin
|
| Outcome Measures: |
Primary: Mean amplitude of glycemic excursions (MAGE), MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study., 6 months|Change in C-peptide, C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study., 6 months | Secondary: Change in HbA1c, 6 months|Change in daily insulin dose, 6 months|Change in body mass index (BMI), 6 months|Change in lipid profiles, Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol, 6 months|Adverse effects, Adverse effects are recorded at each time-point of the follow-up, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Second Xiangya Hospital of Central South University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-08-01
|
| Completion Date: |
2021-04-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-03-18
|
| Locations: |
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03513874
|
